IT Solutions

IT Solutions
Your information technology directory
26| Company Directory
25| Adverse Events
Clinical Project Management
30| Custom Application Development
Data Collection and Management
31| Data Mining and Visualization
Data Warehousing
Document Management
Electronic Data Capture (EDC)
32| Electronic Submissions
IT Consulting
Knowledge Management
Statistical Analysis
Count on the Applied Clinical
Trials 2003 IT Solutions Directory
to learn who provides
applications for clinical trials—
and how to reach them. To find
the right tools for your trials,
search the categorized directory.
33| Training
Trials Management and
Administration Validation
34| Web-Based Software
Wireless/Mobile Technologies
Other Applications
24
APPLIED CLINICAL TRIALS SUPPLEMENT
actmagazine.com
March 2003
DataLabs
DataLabs CTMS
DataLabs CTMS is the first Internet-based product that
integrates the elements of project, data, and document
management into a single application. Based in
Microsoft’s .NET framework and servers, this integrated
approach provides significant benefits, including an accelerated time to market, lower development costs, and
improved research quality.
Datapharm Australia Pty. Ltd.
SMART
SMART (Smooth Monitoring A Resource Tool) was developed by Datapharm to assist project managers of clinical
trials to assess and track monitoring requirements over
several projects and to adjust estimates based on actuals
iteratively. It is quick to use and allows monitoring of
actuals vs. estimated progress milestones.
eResearch Technology, Inc.
Project Assurance
Adverse Events
Aris Global
complaints, nonconformities, vigilance reporting, product
tracking, and more. This easy-to-use and 21 CFR
11–compliant module is fully configurable, scalable, and
secure.
ARISg
The most advanced software for pharmacovigilance and
global regulatory compliance, enables the collection,
coding, reporting, and analysis of clinical and spontaneous adverse events—from multiple sources, in realtime. A global modular system that can be deployed as a
client-server or web-based solution, ARISg is 21 CFR
11–compliant, supports all E2B and MedDRA standards,
and is also available as a Japanese, Kanji-based system.
ARISg has a multiple of add-on options including: personalized Workflow with built-in Safety Alerts, in-depth Ad Hoc
Analysis, Signal Generation and Risk Management with
SafetyMART, and the ability to easily interface with other
applications (e.g., CDMS, EDC, CTMS, Product
Complaints, Drug Registration Tracking systems, etc.). You
can also scan, store, and track documents, as well as link
directly to Documentum.
NetRegulus
StudyExpert See Trials Management/Administration
Sierra Scientific Software, Inc.
Clinical Research Infomation Systemä (CRISä), v7.1
See Trials Management/Administration
Winchester Business Systems, Inc.
adWATCH-e
adWatch helps the clinical trial team track AEs and SAEs
as well as product inquiries and complaints from around
the world. Integrates seamlessly with Protocol Manager,
our clinical trials management system. Automatically
generates CIOMS and MEDWATCH 3500 reports for
electronic submission. Uses MedDRA and/or user defined
dictionaries. Conforms to 21 CFR 11.
Assured Information Systems
PV-Works
PV-Works is the leading workflow-driven pharmacovigilance
system. It is 21 CFR 11 compliant, includes MedDRA
coding and E2B. The software can inherit your own
workflow processes and can be installed on site or run as
an outsourced pharmacovigilance service. Assured and
PV-Works are able to meet your pharmacovigilance system
needs.
Carevoyance Telematics
Catalyst See Wireless/Mobile Technologies
eResearch Technology, Inc.
Clinical Project Management
BBK Healthcare, Inc.
TrialCentralNet
TrialCentralNet is BBK’s e-process management system
for maximizing site enrollment capability through the
creation of relationships with clinical study sites. The
comprehensive suite of Web-based tools includes
modules specific to sponsors, sites and BBK. Providing
ongoing data and communications access in real-time,
TrialCentralNet creates a “virtual community” among key
parties and maximizes productivity.
A full spectrum of consulting and project assurance
services that augment the implementation trial execution
efforts of clients. The spectrum of services includes study
initiation, project management, education, configuration,
technology and regulatory review, research dashboards
and electronic reporting, uniform standards and standard
operating procedures, and migration services. The
Company provides on-site research and technology
advisory services, support services, and a global
customer care 24X7 help desk.
Fortress Medical Systems, Inc.
Clindex
Clindex 2.0 integrates the activities of a clinical department, beginning with database design and methodology,
data entry and tracking of CRFs, through the payment of
CRFs and study monitoring, to the statistical analysis and
archiving of study data. Clindex 2.0 meets all FDA requirements for management and auditing of clinical data.
FW Pharma Systems
IMPACT See Trials Management/Administration
ICTI
Interactive Trial Management Solutions
ICTI provides interactive trial management solutions using
state-of-the-art IVRS development tools. Applications
include centralized patient randomization, drug supply
management, IVRS-based patient unblinding, patient diary
data collection, accelerated patient referral, and
automated information distribution. ICTI is the leader in
clinical trial material management with the introduction of
their powerful forecasting and supply chain management
tool.
Integic Corporation
CRF WorkManager
Integic helps life science customers improve drug throughput with technology and services that accelerate research,
while controlling costly but necessary compliance issues
eSafety Net
An Internet-based adverse event management system.
This application facilitates compliance by sponsors, clinical research organizations, and investigators with regulatory reporting requirements regarding adverse events and
with the sponsor’s or clinical research organization’s own
internal requirements for safety data analysis. Sponsors
or clinical research organizations can configure this application to match their own processes and forms.
ClinLogic
ClinProject
ClinProject is a Clinical Trials Management application
providing real-time insight into study progress. The system
provides crucial information for decisions early in the
study cycle before CRFs have been retrieved and entered
into clinical data management. From site initiation,
through grant payment disbursement, ClinProject is an
end-to-end solution.
MAJARO InfoSystems Inc.
ClinAccess Dictionary Coder
ClinLogic
SAS-powered. Integrates with ClinAccess or as
standalone. Works with any dictionary, including MedDRA,
COSTART, WHO, or custom built. Autoencodes exact
matches. Flexible term search, learning capabilities,
entered word as replacement, etc. to assist with uncoded
terms. Variety of reports. Used with entire system, images
dynamically appear for easy coding.
ClinSite See Trials Management/Administration
NetRegulus
IssueExpert
IssueExpert provides all the tools and capabilities necessary for collecting, documenting, tracking, trending, and
reporting product quality issues including adverse events,
corrective and preventive actions (CAPA), audits,
March 2003
ClinSource
TrialXS/TMS
TrialXS/TMS is the integrated Web-based Trial Management System (CTMS) for your clinical research community.
To plan, conduct, and effectively manage clinical trials
through experience, collaboration, and consistent
workflow. The TrialXS Trial Management System (TMS)
addresses the global management aspects of the entire
clinical research process. Including process planning,
finance and resource management, monitoring tools, and
much more.
actmagazine.com
Check Your Information
If you submitted information for the 2003
IT Solutions directory, please carefully
examine your listings, and contact us
about any problems.
If necessary, we will publish an
addendum with corrected information in a
subsequent ACT issue.
Send corrections to IT Solutions Editor
Applied Clinical Trials
859 Willamette Street
Eugene, OR 97401-6806
fax: (541) 984-5250
e-mail: jkerber@advanstar.com
APPLIED CLINICAL TRIALS SUPPLEMENT
25
IT Solutions company directory
A–C
Acumen Healthcare
Solutions, LLC
604-642-2273
fax: 604-642-2293
info@carevoyance.com
www.carevoyance.com
14252 23rd Ave. North
Plymouth, MN 55447, USA
763-559-8232 ext. 23
fax: 765-559-2821
rjl@acumenhealthcare.com
www.acumenhealthcare.com
Clarinet Systems
Advanced Systems
Development
Clinical DataFax Systems Inc.
2000 Alameda de las Pulgas,
Ste. 154
San Mateo, CA 94403, USA
650-292-5300
fax: 650-292-5302
sefanov@advasys.com
www.advasys.com
Analyse-it Software, Ltd.
P.O. Box 103
Leeds LS27 7WZ, UK
+44 113 210 0708
fax: +44 113 229 8424
info@analyse-it.com
www.analyse-it.com
44040 Fremont Blvd.
Fremont, CA 94538, USA
510-249-9661
eotro@clarinetsys.com
www.clarinetsys.com
25 Main St. West, Ste. 500
Hamilton, ON L8P 1H1, Canada
905-522-3282
fax: 905-522-7284
info@datafax.com
www.datafax.com
ClinicalTrialsNet Inc.
12 John St.
Charleston, SC 29403, USA
843-965-5598
fax: 843-965-5849
info@clinicaltrialsnet.com
www.clinicaltrialsnet.com
Clinitrac
2777 Summer Street
Stamford, CT 06905, USA
203-588-3000
fax: 203-356-1673
spalacios@arisglobal.com
www.arisglobal.com
St. Eriksgatan 113
Stockholm, S-113 43,
Sweden
+46 8 5088 0600
fax: +46 8 5088 0609
info@clinitrac.com
www.clinitrac.com
Assured Information Systems
■ ClinLogic
Aris Global
Equity House, 18 Market Square
St. Neots, Cambs PE19 2AF, UK
+44 1 480 21 22 23
fax: +44 1 480 21 64 95
info@assured.co.uk
www.assured.co.uk
BBK Healthcare, Inc.
320 Needham St., Ste. 150
Newton, MA 02464, USA
617-630-4477
fax: 617-630-5090
bbk@bbkhealthcare.com
www.bbkhealthcare.com
Cardio Control
Mercuriusweg 1
Delft, 2624 BC, The Netherlands
+31 15 750 5000
fax: +31 15 750 5050
peter@cardiocontrol.com
www.cardiocontrol.com
Carevoyance Telematics
1245 W. Broadway, Ste. 300
Vancouver, BC V6H 1G7, Canada
26
18436 Hawthorne Blvd.,
Ste. 208
Torrance, CA 90504, USA
310-921-6025
fax: 310-921-2835
info@clinlogic.com
www.clinlogic.com
ClinSource
Mechelsesteenweg, 455 Bus 2
Kraainem B-1950, Belgium
+ 32 2 766 00 80
fax: +32 2 766 00 81
fdemeyere@clinsource.com
www.clinsource.com
CRF Box
Reservoir Place, 1601 Trapelo
Rd.,
Ste. 241
Waltham, MA 2451
781-466-6100
fax: 781-466-6900
info@crfbox.com
www.crfbox.com
APPLIED CLINICAL TRIALS SUPPLEMENT
Cytel Software Corp.
675 Massachusetts Ave.
Cambridge, MA 02139, USA
617-661-2011
fax: 617-661-4405
info@cytel.com
www.cytel.com
440-443-0082
fax: 216-921-6702
contact@datatraknet.com
www.datatraknet.com
E–F
Dynarand
D–F
DataCeutics, Inc.
1610 Medical Dr., Ste. 300
Pottstown, PA 19464, USA
610-970-2333
fax: 610-970-4884
jamessu@dataceutics.com
www.dataceutics.com
Datafarm Inc.
275 Boston Post Rd., Ste. 2
Marlborough, MA 01752, USA
508-624-6454
fax: 508-624-0848
info@datafarminc.com
www.datafarminc.com
DataLabs
17310 Redhill Ave., Ste. 200
Irvine, CA 92614, USA
949-851-2030
fax: 949-851-2043
info@datalabs.com
www.datalabs.com
Datapharm Australia Pty. Ltd.
56-56A Thompson St.
Drummoyne, NSW 2047,
Australia
+612 9719 2800
fax: +612 9719 2811
info@datapharm.com.au
www.datapharm.com.au
DataSpectrum, Inc.
4700 Falls of Neuse Rd.,
Ste. 400
Raleigh, NC 27609, USA
800-497-1678
fax: 919-431-9961
info@dataspectrum.com
www.dataspectrum.com
DATATRAK Deutschland GmbH
Rochusstrasse 65
Bonn 53123, Germany
+49 228 979 8320
fax: +49 228 979 9492
contact@datatraknet.com
www.datatraknet.com
DATATRAK International, Inc.
6150 Parkland Blvd., Ste. 100
Mayfield Hts, OH 44124, USA
actmagazine.com
55 Francisco St., Ste. 780
San Francisco, CA 94133, USA
(888)794-IVRS(4877)
fax: (415) 362-4525
info@dynarand.com
www.dynarand.com
ePharmaLearning
625 Ridge Pike, Building E, Ste.
402 Conshohocken, PA 19428,
USA
215-643-3318
fax: 215-893-4024
info@epharmalearning.com
www.epharmalearning.com
ePocrates, Inc.
1800 Gateway Dr., Ste. 300
San Mateo, CA 94404, USA
650-227-1700
fax: 650-227-2770
tbrandis@epocrates.com
www.epocrates.com/
trialservices
■ eResearch Technology, Inc.
30 S. 17th St.
Philadelphia, PA 19103, USA
866-669-4324
fax: 908-541-0091
eresearch@ert.com
www.ert.com
Fortress Medical Systems,
Inc.
901 1st St. North
Hopkins, MN 55343, USA
952-238-9010
mjones@fortressmedical.com
www.fortressmedical.com
FW Pharma Systems
Four Brindleyplace
Birmingham, B1 2JB, UK
+44 121 616 5616
fax: +44 121 616 5601
info@fwpharma.com
www.fwpharma.com
G–I
Gupta Programming
213 Goldenwood Circle
Simi Valley, CA 93065, USA
805-577-8877
fax: 413-383-3543
Sunil@GuptaProgramming.com
www.GuptaProgramming.com
Healthcare Technology
Systems, Inc.
7617 Mineral Point Rd.,
Ste. 300
Madison, WI 53717, USA
800-316-2414
fax: 608-827-2444
sales@healthtechsys.com
www.healthtechsys.com
Honeywell/POMS
13655 Dulles Technology Dr.
Herndon, VA 20171, USA
703-793-4400
fax: 703-793-4401
www.poms.com
ICTI
1040 Stony Hill Rd., Ste. 200
Yardley, PA 19067, USA
267-685-4284
fax: 267-685-4262
info@icti-usa.com
www.icti-usa.com
idv Data Analysis & Study
Planning
Wessobrunner Str. 6
Gauting/Munich 82131,
Germany
+49 89 850 80 01
fax: +49 89 850 36 66
idvGauting@aol.com
iMedRIS Data Corp.
36213 Highland Ave.
Yucaipa, CA 92399, USA
909-520-9164
fax: 909-520-0031
Sales@imedris.com
www.iMedRIS.com
InferMed Limited
25 Bedford Square
London WC1B 3HW, UK
+44 20 7291 7410
fax: +44 20 7291 7489
infermed@infermed.com
www.infermed.com
InfoPro Solutions
31365 Oak Crest Dr., Ste. 250
Westlake Village, CA 91361,
USA
818-879-0075
fax: 818-879-7303
info@infoprosolutions
www.infoprosolutions.com
Insightful
March 2003
1700 Westlake Ave. North,
Ste. 500
Seattle, WA 98109, USA
206-283-8802
fax: 206-283-8691
info@insightful.com
www.insightful.com
30 E. 60th St.
New York, NY 10022, USA
877-511-4200
fax: 212-813-2102
mbayer@medidatasolutions.com
www.medidatasolutions.com
Integic Corporation
■ Mini Mitter Co., Inc.
14585 Avion Parkway
Chantilly, VA 20151
703-222-2840
www.integic.com
IntraLinks, Inc.
1372 Broadway, Floor 11
New York, NY 10018, USA
212-543-7700
fax: 212-543-7801
info@intralinks.com
www.intralinks.com
invivodata, inc.
5615 Scotts Valley Dr.,Ste. 150
Scotts Valley, CA 95066, USA
831-438-9550
fax: 831-440-1770
info@invivodata.com
www.invivodata.com
J–N
■ LifeTree Technology
41093 County Center Dr.
Temecula, CA 92591, USA
800-211-2799
fax: 877-659-5433
mmyhre@lifetree-tech.com
www.lifetree-tech.com
Liquent, Inc.
1300 Virginia Dr., Ste. 125
Fort Washington, PA 19034,
USA
800-515-3777
fax: 215-654-7724
info@liquent.com
www.liquent.com
Logos Technologies Ltd.
Chiltern House Feathers Yard
Basingstoke Hampshire,
RG21 7AT, UK
+44 1256 478900
fax: +44 1256 473332
info@logostechnologies.com
www.logostechnologies.com
■ MAJARO InfoSystems Inc.
2350 Mission College Blvd.,
Ste. 700
Santa Clara, CA 95054, USA
408-330-9400
fax: 408-330-9410
info@majaro.com
www.majaro.com
■ Medidata Solutions, Inc.
28
PharmaPros Corporation
245 First St., #1851
Cambridge, MA 02142, USA
978-207-0067
fax: 978-207-0067
Laurine.Pineo@pharmapros.com
www.pharmapros.com
PharmaTech Solutions, Inc.
20300 Empire Ave., Building B-3
Bend, OR 97701, USA
800-685-2999
fax: 541-322-7277
mm@minimitter.com
www.minimitter.com
3534 South College Rd., Ste. I
Wilmington, NC 28412, USA
888-896-7425
fax: 910-392-7275
info@pharmatechsolutions.com
www.pharmatechsolutions.com
Mousley Consulting
■ Phase Forward
Incorporated
608 West Main
Lansdale, PA 19446, USA
484-433-7300
fax: 215-631-1367
aperelli@mousleyconsulting.com
www.clinport.com
1440 Main St.
Waltham, MA 02451-1623, USA
781-890-7878
fax: 781-890-4848
info@phaseforward.com
www.phaseforward.com
NetRegulus
PHT Corporation
One Tower Lane, Ste. 1700
Oakbrook Terrace, IL 60181,
USA
888-707-6900
fax: 630-573-6050
info@netregulus.com
www.netregulus.com
500 Rutherford Ave.
Charlestown, MA 02129, USA
617-973-1820
fax: 617-973-1821
kquinn@phtcorp.com
www.phtcorp.com
O–R
OmniComm Systems, Inc.
2555 Davie Rd., Ste. 110-B
Fort Lauderdale, FL 33317, USA
954-473-1254
fax: 954-473-1256
info@omnicomm.com
www.omnicomm.com
■ PAREXEL International
Corporation
195 West St.
Waltham, MA 02451-1163, USA
781-487-9900
fax: 781-487-0525
parexelclientmaster@parexel.com
www.parexel.com
■ Perceptive Informatics,
Inc.
200 West St.
Waltham, MA 02451
781-487-9900
781-434-5916
techinfo@perceptive.com
wwwperceptive.com
PerMedics, Inc.
1475 South Victoria Court
San Bernardino, CA 92408, USA
877-473-7633
fax: 909-478-5016
moreinfo@permedics.com
www.permedics.com
APPLIED CLINICAL TRIALS SUPPLEMENT
ProIRB Plus, Inc.
6020 44th Ave. North
St. Petersburg, FL 33709, USA
727-545-5314
fax: 727-541-2433
info@proirb.com proirb.com
Propack Data
2000 Regency Parkway,
Ste. 675
Cary, NC 27511, USA
919-465-1741
fax: 919-465-1742
contact.us@propack-data.com
www.propack-data.com
Relsys International, Inc.
16267 Laguna Canyon Rd.
Irvine, CA 92618, USA
949-453-1715
fax: 949-453-1817
info@relsys.net
www.relsys.net
S–T
SAS Institute Inc.
SAS Campus Dr.
Cary, NC 27513, USA
800-727-0025
fax: 919-877-4444
www.sas.com/industry/pharma/
drug_dev.html
Ste. 150 South
Morrisville, NC 27560, USA
919-467-1997
fax: 919-467-1109
info@secassociates.com
www.secassociates.com
■ Sierra Scientific Software,
Inc.
1325 55th St.
Oakland, CA 94608-2609, USA
510-655-2441
fax: 510-217-3519
info@sierraware.net
www.sierraware.net
Stat-Ease, Inc.
2021 East Hennepin Ave.,
Ste. 480
Minneapolis, MN 55413, USA
612-378-9449
fax: 612-378-2152
info@statease.com
www.statease.com
StudyBuilder Limited
John Eccles House
Robert Robinson Ave.
The Oxford Science Park, OX4
4GP, UK
+44 1865 338 092
fax: +44 1865 338 100
info@studybuilder.com
www.studybuilder.com
U–Z
Validation Wizards
International
P.O. Box 100
West Mystic, CT 06388-0100,
USA
860-572-7255
fax: 860-536-9419
Tim_Fields@drumkey.com
www.drumkey.com
Velos, Inc.
2201 Walnut Ave., Ste. 208
Fremont, CA 94538, USA
510-739-4010
fax: 510-739-4018
marketing@veloseresearch.com
www.veloseresearch.com
■ Vital Link.net
14450 NE 29th Place, Ste. 108
Bellevue, WA 98007, USA
425-861-5000
fax: 425-861-5099
info@vitallink.net
www.vitallink.net
SyMetric Sciences, Inc.
Vitalograph Inc
1-2082 Sherbrooke West
Montreal, QC H3H 1G5, Canada
514-935-4562
fax: 514-935-9911
major@symetric.ca
www.SyMetric.ca
8347 Quivira Rd.
Lenexa, KS 66215, USA
913-888-4221
fax: 913-888-4259
pharma@vitalograph.co.uk
www.vitalograph.com
Synteract
Vitalograph Ltd.
5759 Fleet St., Ste. 100
Carlsbad, CA 92008, USA
760-268-8200
fax: 760-929-1419
rholmes@synteract.com
www.synteract.com
Maids Moreton
Buckingham Bucks MK18 1SW,
UK
+44 1280 827120
fax: +44 1280 823302
pharma@vitalograph.co.uk
www.vitalograph.com
Systemsmith
18436 Hawthorne Blvd.,
Ste. 208
Torrance, CA 90504, USA
310-921-2735
fax: 310-921-2835
info@systemsmith.com
www.systemsmith.com
Target Health Inc.
SEC Associates, Inc.
261 Madison Ave., 24th Floor
New York, NY 10016 , USA
212-681-2100
fax: 212-681-2105
julesmitchel@targethealth.com
www.targethealth.com
3900 Paramount Parkway,
TrialTrac, Inc.
actmagazine.com
45 Main St., Ste. 405
Brooklyn, NY 11201, USA
718-237-4000
fax: 718-237-4688
info@trialtrac.com
www.trialtrac.com
Wimmer Systems, LLC
3008 Cochise Dr.
Independence, MO
64057, USA
816-795-5177
fax: 816-795-5177
info@wimmersystems.com
www.wimmersystems.com
Winchester Business
Systems, Inc.
304 Cambrige Rd.
Woburn, MA 01801, USA
781-503-0200
fax: 781-503-0207
sales@wbsnet.com
www.wbsnet.com
March 2003
(professional protocols, process control, data integrity and
government regulations). CRF WorkManager automates
the core of clinical, therapeutic, or device trial processes
using sophisticated document processing and offering
access across multiple geographic locations. It electronically distributes work to data reviewers e.g. CRAs, data
entry staff, medical writers. It has features to integrate
with all major clinical databases and it provides variety of
technologies for taking global clinical trial management
online.
firms. Our combination of clinical trials domain expertise
and technical skill makes Systemsmith the best choice for
all your pharmaceuticals-related custom software development needs.
performed on research subjects in connection with the
Company’s customers’ clinical trials. This service permits
assessment of the safety of therapies by documenting the
occurrence of cardiac electrical charge.
Target Health Inc.
FW Pharma Systems
Target e*CRF See Electronic Data Capture
INITIATOR
Vital Link.net
Multimedia Informed Consent Sessions See Knowledge
Management
IntraLinks, Inc.
IntraLinks
IntraLinks connects business communities and accelerates the intelligent flow of information and documents
among participants. By using IntraLinks as a drug development hub, pharmaceutical companies can communicate
more efficiently with investigators, CROs, IRBs, SMOs,
and other parties while speeding clinical trials. IntraLinks
digital workspaces are fully hosted and supported
24/7/365, and our service has been found to be 21 CFR
11–compliant.
Data Collection/Management
Aris Global
ARISg See Adverse Events
ClinTALK See Wireless/Mobile Technologies
Cardio Control
ABP Perfect
ClinAccess CaseBook See Document Management
PC-based Ambulatory Blood Pressure system. Includes
management of data. Optional software for digital transmission of data.
Clinical DataFax Systems Inc.
ProIRB Plus, Inc.
DataFax
ProIRB
ProIRB is a multi-User, multi-IRB software application
providing productivity and compliance assurance tools for
managing the institutional review board work-flow process
from scheduling to meeting minutes. The application is
developed in MS Access and is currently in use by major
universities and healthcare institutions nationwide.
A complete clinical trials management solution using
CRFs and simple fax technology at the clinical sites and
powerful software at the coordinating center including:
intelligent character recognition from faxed CRFs, query
tracking, standard reports, audit trails, study setup tool,
bookmarked PDFs of patient CRFs, acceptance test kit,
and much more.
Propack Data
ClinicalTrialsNet Inc.
PMX(R) CTM Solution
ClinTriNet
As a result of longtime experience and close cooperation
with leading life sciences companies, PMX(R) CTM represents a software suite tailored for the specific demands
of pharmaceutical development, clinical manufacturing,
and clinical trial management. Our PMX(R) CTM solution is
based on the release-controlled PMX(R) applications wellestablished in the pharmaceutical and biotechnology
industries. It meets the requirements of the highly sensitive and regulated market of clinical studies and complies
with cGMP/GCP guidelines. The process oriented solution,
focuses on both efficiency of the application and the
safety demands of regulatory authorities.
ClinicalTrialsNet has developed a Web-based system that
enables comprehensive data, project, and document
management in a regulatory compliant, on-line environment. Our intuitive user interface makes it easier for you
to focus on trial management, instead of trial software
management. Contact us to bring efficient technology to
your trials!
TrialTrac, Inc.
SiteTrac See Trials Management/Administration
Winchester Business Systems, Inc.
ClinSource
TrialXS/CRF See Electronic Data Capture
Winchester Business Systems develops software applications for pharmaceutical, biotechnology, and medical
device companies designed to improve drug and product
development processes. Winchester implements systems
for multisite/multivendor clinical trials projects, electronic
data collection, workflow management and project
management systems, information management, and
exception reporting for decision support.
Custom Application Development
Insightful
InferMed Limited
MACRO See Electronic Data Capture
invivodata, inc.
invivosystem
invivodata’s electronic patient diary system combines
behavioral and clinical science with handheld and Web
technology to deliver real-time patient self-report data in
clinical trials. invivodata’s science-based diary methods
and proven technology optimize patient compliance and
study sensitivity to maximize confidence in trial data.
Liquent, Inc.
Xtent
Liquent Xtent is an XML-driven engine that instantly
converts information to XML so it can be more widely
used and easily distributed. It works by rendering source
content to XML while retaining document fidelity, structure, content, and metadata. Liquent Xtent technology
increases granularity by breaking content into component
parts.
TrialXS/PDE
Logos Technologies Ltd.
TrialXS/PDE offers flexible possibilities to filter the output
based on countries, sites, patients, or data status.
TrialXS/PDE guarantees highly secured and encrypted
data transfer.
ALPHADAS See Electronic Data Capture
CRF Box
CRF Box eDiary Suite See Electronic Data Capture
Datapharm Australia Pty. Ltd.
eCRF See Electronic Data Capture
MAJARO InfoSystems Inc.
ClinAccess PowerServer
Validated SAS-powered clinical data management software
with integrated dictionary autoencoder, data clarification
system, workflow, imaging, and Web components. Study
setup wizards, automated forms tracking, CRF images
received from scan, fax, or file links directly to data for
view throughout system. Completely operational within 30
days. Easily customizable by client.
DataSpectrum, Inc.
Statistical Analysis & Reporting
MAJARO InfoSystems Inc.
DataSpectrum is an innovative data and statistical
services company, providing the ability to use EDC, paper,
and fax data collection methods in one study, in one
validated system, using Oracle Clinical. This gives you the
flexibility to pick a site based on patient enrollment and
quality—not the site’s technological ability.
ClinAccess Web See Web-Based Software Services
Mini Mitter Co., Inc.
Actiwatch Actigraphy Monitors See Electronic Data
Capture
NetRegulus
S+SeqTrial
S+SeqTrial is an S-PLUS software library for designing,
monitoring, and analyzing clinical trials using group
sequential methods. The main design focus is choosing
the sample size that allows the clinical trial to discriminate between the null and alternative hypotheses, thereby
answering the scientific questions of interest.
eResearch Technology, Inc.
ActivityExpert See Electronic Data Capture
eData Management
StudyBuilder Design Consultancy See IT Consulting
An Internet-based technology for collecting, editing, and
managing clinical trial data in any computing environment.
Customers use this technology to analyze data, resolve
incomplete or erroneous data entries, and support early
locking of the database for a particular trial. This product
easily integrates with a wide variety of third-party applications for imaging, workflow, and data analysis.
Systemsmith
eResearch Technology, Inc.
Services Systemsmith is a Microsoft Certified Partner
EXPeRT
focused on custom software development for clinical
trials. We have experience developing mission-critical
systems for large sites, CROs, and patient recruiting
Intelligent, workflow-enabled data handling and distribution of paper-based and digital ECG data and images as
well as analysis and cardiologist interpretation of ECGs
APPLIED CLINICAL TRIALS SUPPLEMENT
Clinical IVR Systems See Electronic Data Capture
ClinSource
Custom application development
30
Expedite and standardize new development based on prebuilt and validated best practices clinical trial reporting
templates. Reuse and customize best practices templates
to individual clinical trial studies. Ideal environment for
leveraging and reusing existing SAS code. Ensure compliance by using best practices SOP and validation documentation for IQ and OQ requirements.
Healthcare Technology Systems, Inc.
Clinport See Trials Management/Administration
StudyBuilder Limited
Gupta Programming
Best Practices Clinical Trial Reporting Templates
Aris Global
MAJARO InfoSystems Inc.
Mousley Consulting
INITIATOR is a complete solution for improving productivity
and access to both operational and planning data in the
Phase 1 arena. Using electronic data capture techniques,
INITIATOR provides fast access to real-time, quality
assured data. And the system automates many laborintensive tasks to ensure that studies are conducted cost
effectively.
actmagazine.com
NetRegulus
RegistryExpert
RegistryExpert allows users to link and track products,
patients, care facilities, capital equipment, medical
professionals, and more. Register and track capital equipment and products by product number, serial/lot number,
date, or your own system. Features multiple address
capability to quickly locate patients with products in critical situations.
PerMedics, Inc.
Encaptor EDC System
Encaptor enables data managers obtain trial data in real
March 2003
time from anywhere in the world. Complex case report
forms with validation and edit checks are designed easily
using design templates. The XML based system is 21 CFR
11–compliant with audit trail and multi-level security
features. PerMedics’ software suite includes trial management solutions.
PharmaPros Corporation
NetRegulus
ReportExpert
ReportExpert provides detailed, Web-enabled internal
analytical reporting for decision makers, as well as regulatory reporting for all phases of a product’s life cycle.
Includes a library of standard reports and intuitive tools to
create unlimited ad hoc reports, charts, and graphs.
Generates and emails regularly scheduled reports.
DataVal See Other Applications
PharmaPros Corporation
Data Warehousing
NCompass
NCompass is a comprehensive clinical systems environment that provides Clintrial, Clintrace, CRFTrack, DataVal
and other 3rd party products as an integrated web-based
solution. NCompass includes all the software, services,
and technical support needed to run clinical trials.
comprehensive audit trails. If you need a system to
accommodate off-line and/or on-line data entry without
changing your database, TracIt2k can do it affordably.
Cardio Control
Recollect
ECG event recorder system for acquisition of high-resolution ECG data. System can record up to 180 minutes of
data, 1 or 2 channels.
Clinical DataFax Systems Inc.
DataFax See Data Collection/Management
Liquent, Inc.
Clinitrac
IDRAC
Clinitrac Patient Diary, Clintrac Visit Diary
Wireless patient diary that enables collection and monitoring of patient data in real-time.
See Training
IDRAC is a global regulatory intelligence database that
helps to accelerate your product’s entrance into the worldwide marketplace by delivering highly focused information
on ever-changing requirements. It brings together all the
information you need to stay up-to-date on regulatory
requirements in 30 countries.
SyMetric Sciences, Inc.
Vital Link.net
SyMetric Clinical Data Management system
Vital Source See Data Collection/Management
StudyBuilder Limited
Complete Introduction to StudyBuilder Training Course
Comprehensive data management system for clinical
trials including full support for double data entry, multivariate data validation, data dictionary, autoencoders for all
standard dictionaries (ICD9, MedDRA, WHO, etc.), query
management, flexible export to ASCII, HTML, and SAS,
etc. Complies with all regulatory requirements. For more
information, please visit our Web site.
Document Management
Aris Global
REGISTER See Knowledge Management
Synteract
IntraLinks, Inc.
SynCoder
IntraLinks See Clinical Project Management
SynCoder is an SAS application that implements the
MedDRA terminology, as well as COSTART and WHO-DRUG
dictionaries, for coding adverse event and medication text
reported during clinical trials or post-marketing. The
product requires SAS v8.1 or higher, and works with SAS
v6 or v8 databases.
TrialTrac, Inc.
TrialWorks
TrialWorks is clinical trials management software designed
for sponsors and CROs. It's easy to use, quick to implement, customizable, and 21 CFR 11 compliant. Our
integrated design is comprehensive, and tracking includes
investigator payments and earnings, patient information,
essential documents, clinical supply inventory, and every
step in between. TrialWorks is also available through our
e-Service-we are your ASP.
Vital Link.net
Vital Source
The Vital Source clinical data management system
(CDMS) is a flexible and secure data repository. Its
intuitive format ensures that any user, regardless of
computer skill level, can set up an effective study
database, collect and export data into a statistical analysis tool, and quickly generate study reports.
Vitalograph Ltd.
Spirotrac Centralized Spirometry System See Electronic
Data Capture
Wimmer Systems, LLC
DaCS (Data Compliance System)
DaCS is the original stand-alone 21 CFR 11 compliance
solution for Microsoft Excel, providing security, audit trails,
and true electronic signatures in a low-cost, low-overhead,
and customizable solution. Free demonstration software
allows you to conduct a full evaluation before purchasing.
Data Mining/Visualization
ClinSource
Insightful Miner
Insightful Miner Desktop Edition is the first affordable, nocompromise data mining workbench that gives new data
miners and skilled modelers the ability to deploy predictive intelligence throughout the enterprise.
March 2003
TrialXS/CRF
TrialXS/CRF is a Web-enabled CRF design tool to create,
design, program, and change Clinical Research Forms in a
fast, accurate, remote, and secure environment. It works
fully integrated with the TrialXS trial management and data
capture system.
CRF Box
CRF Box eDiary Suite
Electronic Patient Diary solution to collect primary and
secondary efficacy data from all patient populations.
Incorporating PDA handheld devices and mobile phones
using worldwide communications technology, pharma
companies are able to collect high-quality data reliably on
a global scale. Trial visibility and control is provided
through online role based portal and reporting technology.
Liquent, Inc.
CoreDossier
DataLabs
CoreDossier lets you easily and efficiently manage multiple, simultaneous report and submission dossiers. The
backbone of this product suite is its unparalleled PDFrendering technology, which ensures that exact page
fidelity is maintained at all times. With a single, cohesive
interface, it works with no modification on most document
management systems.
DataLabs CTMS See Clinical Project Management
Liquent, Inc.
CoreReports
CoreReports is Liquent's browser-based publishing
solution designed specifically for organizations that use
Documentum and want to extend publishing capabilities
to multiple departments. By using CoreReports to ensure
that your documentation––from R&D through clinical trials
––is properly formatted, you gain a significant head start
in producing and submitting high-quality dossiers.
MAJARO InfoSystems Inc.
ClinAccess CaseBook
An imaging component, designed to take advantage of full
integration with our PowerServer product. Receives
images from fax, scan or file format making this “case
book oriented” imaging system very flexible. Recently we
added OCR (optical character recognition) capabilities for
use in situations where appropriate. Integration with
PowerServer not only eliminates duplicity of efforts and
simplifies validation, it keeps the image tied to the data at
all times. Combined with a group of management tools for
annotating forms, multiple view, and search tools,
workflow capabilities make this component revolutionary
in clinical data management.
Datapharm Australia Pty. Ltd.
eCRF
eCRF is a remote data capture tool allowing sites to enter
clinical data offline at the site and send clinical trial data
electronically to Datapharm’s secure server. Fields are
programmed with edit checks and database lookups allowing quick access to clean data which can be viewed on the
Web. System setup and maintenance is cost effective.
DataSpectrum, Inc.
Oracle Clinical RDC See Data Collection/Management
DATATRAK Deutschland GmbH/
DATATRAK International, Inc.
DATATRAK EDC
DATATRAK International, Inc., with offices in Cleveland,
OH, and Bonn, Germany, specializes in electronic data
capture using DATATRAK EDC. The product suite operates
in centralized or stand-alone modes, and offers state-ofthe-art security and real-time data entry and review.
Electronic site assessment, Web-based training offered.
Dynarand
Electronic Diaries
Dynarand's Interactive Voice Response (IVR) and Webbased Electronic Diaries are a convenient, user-friendly
means of collecting patient data and improving patient
compliance. They provide an economic alternative to other
diary collection methods.
ePocrates, Inc.
Winchester Business Systems, Inc.
Honors Trial Feasibility Research See Trials Manage-
Health Agency Tracking
ment/Administration
The Health Agency Tracking system tracks all documents
associated with queries and responses made by and to
regulatory agencies. Automatic workflow notifies all interested parties and initiates action items for resolution of
the query. Maintains complete audit trail. Conforms to 21
CFR 11 regulations for electonic records and signatures.
TrialXS/PDE See Data Collection/Management
Insightful
ClinSource
Electronic Data Capture
eResearch Technology, Inc.
eData Entry
An electronic data capture (EDC) system permitting investigators to use standard Internet browser tools to input
data into a centralized database in an online or offline
environment. eData Entry accommodates traditional
manual, paper-based data entry, data entry using the
Internet and other forms of electronic data transmission.
eData Entry can also capture data in the form of
electronic images.
Acumen Healthcare Solutions, LLC
TracIt2k EDC System
Healthcare Technology Systems, Inc.
TracIt2k is the most affordable and flexible EDC solution
available today. Quickly and easily create, design and
modify your own e-CRFs complete with error checks and
Clinical IVR Systems
Led by three distinguished medical professionals, Healthcare Technology Systems (HTS) is the world leader in
actmagazine.com
APPLIED CLINICAL TRIALS SUPPLEMENT
31
developing and delivering clinical IVR systems to gather
data directly from patients. HTS offers more than 30 IVR
clinical rating scales, including the HAMD and the McGill
Pain Questionnaire, plus research and clinical expertise.
PHT Corporation
StudyBuilder Limited
LogPad
StudyBuilder Enterprise Server See Web-Based Software
Electronic patient diary
Services
StudyBuilder Limited
InferMed Limited
StudyBuilder Enterprise Edition
MACRO
StudyBuilder Enterprise Edition ($4999/study designer;
no site/subject/data manager fees) Integrated study
design, data management, and collection software
package. Use wizards and drag-and-drop to design and
deploy your study. Includes data collection/management
system for Web, palmtop, and desktop computers and
integrates data from spirometers, etc. automatically.
MACRO is InferMed’s electronic data collection solution
for clinical trials. MACRO is an easy-to-use system that
can guide you smoothly through the transition from paper
to electronic clinical data capture systems. MACRO has
intuitive, interactive tools for study definition, on-line and
off-line remote data entry and study monitoring. MACRO is
the only independent EDC system fully integrated with
Oracle Clinical.
Target Health Inc.
Target e*CRF
LifeTree Technology
ICTM, ILMS
LifeTree Technology is a proven performer with the vision,
capabilities and resources expected in a web-based EDC
partner. LifeTree’s ICTM is uniquely easy to learn, deploy
and maintain. Our web-based Double Data Entry eases
the transition from paper to EDC. ILMS is a 21 CFR
11–compliant laboratory sample inventory management
system. With comprehensive ASP services, 24/7 support
and independently confirmed compliance, LifeTree
Technology is leading the transition from paper to EDC.
Logos Technologies Ltd.
ALPHADAS
Logos Technologies is a global provider of System
Solutions for Drug Research to the world’s Pharmaceutical
and Clinical Research Organisations. Our market leading
products, ALPHADAS and Smart Patient Diary Card have
successfully improved our clients study efficiency,
provided compliant data, achieved a faster database
closure, as well as dramatically reducing cost. Logos
Technologies prides itself on its high-quality solutions
which meet GCP & FDA regulatory compliance such as 21
CFR 11.
e*CRF is a proprietary Internet-based remote data entry,
data management, and project management system,
created and managed exclusively by Target Health Inc.
Data are entered through a Web interface (browser)
directly to a remote database. No software is installed
and the system is fully functional even if used with a 28.8
modem. The system is validated and 21 CFR 11–compliant. An NDA was recently approved which used the
system. The FDA site audit was flawless.
Advanced Systems Development
Clinical IT systems implementation consulting
Implementation and integration consulting services for
Oracle Clinical, TMS, AERS, and other IT clinical systems.
DataCeutics, Inc.
IT Support and Services for the Clinical Research
Environment
DataCeutics is the leader in Clinical Information Technology. DataCeutics offers products and services from three
business lines: Clinical Systems Services (CSS), Clinical
Reporting Services (CRS), and Computer Systems Compliance Services (CSCS). DataCeutics performs turnkey
implementations of the leading clinical data management
systems, comprehensive validation services, SAS
Programming, and clinical reporting solutions
Datafarm Inc.
Vital Link.net
Clinical Information Technology Consulting See
Vital Tracker
Electronic Submissions
The Vital Tracker application is a powerful yet easy-to-use
electronic data capture system. Through key features such
as automated edit checks, Vital Tracker saves time and
improves the validity and integrity of the study data. The
system is available either Web-based or through the Vital
Link solution for clinical trials.
eResearch Technology, Inc.
Project Assurance See Clinical Project Management
InfoPro Solutions
Clinicopia Suite See Trials Management/Administration
Vitalograph Inc
StudyBuilder Limited
Electronic PEF/FEV1 Diary system
StudyBuilder Design Consultancy
As above for data transfer or via mobile phone direct from
patients’ homes.
StudyBuilder Design Consultancy ($599 per hour on-site,
$299 per hour off-site). Outsource study design and
implementation based on StudyBuilder products to our
consultants including protocol and paper case report form
design (includes layout, development of validation criteria,
documentation and testing). Typical project requires
between 40 and 160 hours of consultancy.
Vitalograph Ltd.
Medidata Solutions, Inc.
Spirotrac Centralized Spirometry System
Medidata RAVE
Vitalograph has been a world leader in respiratory
diagnostics for almost 40 years. The Centralized Spirometry System transmits encrypted data everyday via email
from investigator sites direct to the sponsor or via a
dedicated and unique over-read software system where
data quality is ensured on a daily basis. Alternatively, the
clinic software can be interfaced with an Internet EDC
system for data exchange.
Medidata RAVE offers an integrated suite of clinical trial
solutions including Electronic Data Capture, study and site
management, and patient diaries. Our “zero client” application is quick to learn, easy to use. You select hardware,
software, and connectivity; as long as you can access the
web, your trials commence with split-second page turns.
IT Consulting
Systemsmith
Services See Custom Application Development
Knowledge Management
Mini Mitter Co., Inc.
Actiwatch Actigraphy Monitors
Actiwatches are wrist-worn, 17.5-g medical devices for
monitoring subject activity and analyzing sleep and circadian rhythm patterns. Used for supplementing patient
diaries with objective data, verifying subject compliance
with trials protocol, and tracking treatment efficacy.
Actiwatch-Score includes an LED touchpad for patient
input of subjective rating on pain levels, anxiety, etc.
NetRegulus
ActivityAnywhere See Wireless/Mobile Technologies
NetRegulus
ActivityExpert
ActivityExpert is an entirely Web-based solution that
enables any authorized person to input information into
NetRegulus’ PQIntelligence Software System. This product
is ideal for vendors, field representatives, auditors, clinical trial personnel, and others who require limited access
to the system’s functionality.
OmniComm Systems, Inc.
TrialMaster
OmniComm Systems provides Web-based applications for
the collection and primary validation of clinical trial data.
Our applications include electronic CRFs, patient enrollment tracking, randomization, email communication,
reporting, trial management, and more.
Electronic Submissions
Aris Global
E2B Gateway
Designed as a stand-alone, secure, user-friendly webbased application, E2B Gateway comes with built-in
Cyclone Interchange software, can connect to any pharmacovigilance system, and facilitates the transfer and
management of compliant E2B files to global and local
regulatory authorities. And with E2B Gateway, companies
can easily exchange critical safety information with global
trading partners
Datafarm Inc.
Clinical Information Technology Consulting
Datafarm provides electronic document publishing, clinical
data management, statistical analysis and reporting,
document management systems, and custom application
development solutions. Functionally, Datafarm solutions
maximize the quality of publishing and efficiency of
document life-cycle management.
MAJARO InfoSystems Inc.
APPLIED CLINICAL TRIALS SUPPLEMENT
The most comprehensive global drug registration and
tracking system. Compliant with the latest regulatory
guidelines, REGISTER provides for reliable and accurate
product information (e.g., preferred name, ingredients,
International birth date, registration renewals formulations, approval status, registration number, etc), global
monitoring of activities, and compliance for manufacturing
and QC regulations.
eResearch Technology, Inc.
eResearch Community
A central command and control portal that provides realtime information related to monitoring clinical trial activities, data collection, and safety. This Internet-based tool,
which includes research dashboard and health education
modules, allows participants in the clinical trial to follow
the progress and conduct of a study based on frequently
updated data using the Internet. The participant can
analyze data and generate reports in a broad variety of
formats that permit early strategic intervention in the clinical trial.
Insightful
ment
InFact
SAS Drug Development See Knowledge Management
Encaptor EDC System See Data Collection/Management
32
REGISTER
ClinAccess PowerServer See Data Collection/Manage-
SAS Institute Inc.
PerMedics, Inc.
Aris Global
actmagazine.com
InFact is currently the only commercial technology of its
kind to embody human-like intelligence, thereby empowering knowledge workers and decision-makers to make
better decisions faster in a wide range of critical, highvalue business areas.
March 2003
MAJARO InfoSystems Inc.
Stat-Ease, Inc.
ClinAccess Dictionary Coder See Adverse Events
Design-Ease Software
NetRegulus
PQIntelligence
PQIntelligence is a 21 CFR 11–compliant software suite
that provides enterprise-wide, Web-enabled data management specifically for the medical products industry.
Working in the background, PQIntelligence organizes,
automates, and manages clinical, regulatory, and other
product quality data, while you focus on what you do best
—developing and marketing your product.
distribute supplies, manage the financial aspects of a trial,
and electronically view clinical trial data on the Internet.
Design-Ease is an entry-level program for design and
analysis of two-level and general factorial screening experiments. Detect main effects and interactions that lead to
breakthrough improvements. In addition, the software
handles any number of categorical factors at any number
of levels, thus offering extreme flexibility for most screening needs.
Training
SAS Institute Inc.
SAS Drug Development
ePharmaLearning
By streamlining research activities, providing centralized
web-based data access, automating processes for complying with government regulations and industry standards,
and offering core data transformation, analysis, and exploration tools, SAS Drug Development provides the intelligence needed to make more informed clinical and
business decisions, ultimately bringing drugs to market
more quickly and efficiently.
eMeetings, eLearning See Web-Based Software Services
Vital Link.net
Validation Wizards International
Multimedia Informed Consent Sessions
Validation Wizard for Application User Teams
Multimedia consent sessions improve adherence to clinical trial protocols and significantly increase patient retention within the trial. These sessions use 3-D animations,
text, and exam questions to educate subjects and verify
their understanding. Multilingual presentation and content
written at a 6–8th grade level guarantees subjects can
easily understand the information.
Validation Wizard for Application User Teams is a “read and
click” application that trains the trainer and the user team
in the ABCs of computerized system validation (CSV) for
user acceptance of regulated systems. Wizard teaches a
common-sense approach for integrating CSV into the
normal workflow of regulated areas.
StudyBuilder Limited
FW Pharma Systems
IMPACT
IMPACT is the market leader in Clinical Trials Management
Software. It is designed to assist pharmaceutical companies, CROs, device manufacturers, and biotech companies
in managing research activities—ranging in scale from
single site to large multinational, multi site studies, and
from first use in man to single or multi-country marketing
studies. IMPACT will give you total flexibility in the level of
detail tracked, while maintaining complete consistency
across the user base. Most importantly, IMPACT’s vision is
to support what people do in their day-to-day jobs and help
them make decisions based on the latest enrollment,
payment and milestone information across countries and
sites.
Complete Introduction to StudyBuilder Training Course
Complete Introduction to StudyBuilder Training Course
($499/CD-ROM, DVD, video). An interactive multimedia
guide to using StudyBuilder tools for study design, data
collection and management.
FW Pharma Systems
INITIATOR See Data Collection/Management
Honeywell/POMS
POMS CMS
Statistical Analysis
Trials Management/Administration
Manufacturing execution systems for clinical supplies
manufacturing.
idv Data Analysis & Study Planning
Rancode Plus 3.6
Program for randomizing trial subjects according to the
permuted block scheme with constant or varying block
size. It prepares random code lists, sealed envelopes, and
stick-on labels. Rancode Professional comes with many
facilities for working in a validated environment according
to GCP and FDA regulations. Partial decoding possible
according to a predefined subject list. System(s):
DOS/Windows 98/2000/NT/XP/ME.
Aris Global
Analyse-it Software, Ltd.
globalTRIALS
iMedRIS Data Corp.
Analyse-it Clinical Laboratory
iRIS (internet Research Information System) See Web-
Analyse-it! Method evaluation software for Microsoft Excel.
Includes NCCLS and IFCC protocols, Altman-Bland and
NCCLS bias-plots, Deming, Passing-Bablok and Kappa
method comparisons, NCCLS EP5 imprecision, NCCLS
EP6 linearity, IFCC reference ranges, ROC curves, and
sensitivity and specificity analysis. Visit our Web site to
download a free 30-day trial.
A comprehensive web-based clinical trials project management system (CTMS) for the collection, management,
sharing, analysis, and reporting of study performance data.
With remote data entry support via a standard web
browser, globalTRIALS enhances study set-up, project
management, study-metrics, and tracking, study subject
enrollment, supplies tracking, adverse event tracking,
electronic document exchange, and tracking, etc.
Cytel Software Corp.
ClinLogic
East
ClinProject See Clinical Project Management
Software: The industry standard solution for design,
interim monitoring and simulation of flexible clinical trials.
With East, you can make better decisions sooner about
your trials, stop futile studies early, easily design and
simulate sequential studies and pick the best study
design for your needs, and bring drugs to market sooner.
DataSpectrum, Inc.
Statistical Analysis & Reporting See Data
Based Software Services
InfoPro Solutions
Clinicopia Suite
The Clinicopia Suite is the world’s first purpose-built, industry-specific clinical trials supplies management system
developed from the ground up to meet the unique needs
and concerns of all the groups associated with clinical trial
materials supply. The Suite consists of Clinicopia Supply
Chain, Clinicopia Drug Accountability, Clinicopia Process
Execution, Clinicopia Labeling, and Clinicopia Forecasting.
ClinLogic
ClinSite is a comprehensive solution for SMOs and
research sites, managing all aspects of clinical trial participation from prospecting and enrollment to grant payments
and patient stipends. The system tracks visits and procedures and can enforce protocol visit windows. ClinSite also
includes call center management, media effectiveness,
and medical records.
Collection/Management
Mousley Consulting
Clinport
ClinPort is an Internet portal for clinical study management. It integrates all departments and clinical systems of
your company into one efficient trial management tool
providing immediate cost savings with a modest investment. Clinport applications include Clin Binder, Clin Safety,
IVRS, Clin Reports, Trial Supply, and Clin Contacts.
ClinSource
Gupta Programming
TrialXS/TMS See Clinical Project Management
Data Collection/Management
Datapharm Australia Pty. Ltd.
SMART See Clinical Project Management
idv Data Analysis & Study Planning
Nnpar 1.0
DataSpectrum, Inc.
Program for planning and interpreting sample size and
related topics within the framework of the Wilcoxon-MannWhitney test. Target parameters include sample size,
alpha, beta, and the smallest detectable difference
expressed as Mann-Whitney statistic. It supports tests for
difference and tests for equivalence/non-inferiority, onesided and two-sided. System(s): DOS/Windows
98/2000/NT/XP/ME.
Statistical Analysis & Reporting See Data
Collection/Management
S-PLUS
S-PLUS is the premier solution for exploratory data analysis and statistical modeling. With over 4,200 data analysis functions, including the most comprehensive set of
robust and modern methods available anywhere, S-PLUS
allows you to perform more insightful analyses, create
revealing graphics and make more informed business
decisions.
MAJARO InfoSystems Inc.
ClinAccess SureStart See Data Collection/Management
March 2003
StudyExpert streamlines the management of clinical trial
and other study data, while complying with the FDA’s
Guidance for Industry: Computerized Systems Used in
Clinical Trials and 21 CFR 11. Features intuitive tools to
enter, track, verify, query, view, and export case report from
data as well as input and oversee key management information.
ePocrates, Inc.
DocAlert(r) Messaging See Wireless/Mobile
PerMedics, Inc.
Technologies
Surveyor Trial Management System
ePocrates, Inc.
Honors Trial Feasibility Research
Insightful
NetRegulus
StudyExpert
Best Practices Clinical Trial Reporting Templates See
Using our ePocrates Honors, connect with over 77,000
verified physicians to learn about the likelihood of being
able to recruit certain patient types as well as the feasibility of other aspects of your clinical trial protocol.
ePocrates will program, host, and collect your feedback
data using an online survey system.
Surveyor is a software application designed for single and
multisite clinical trials management. Surveyor tracks trial
progress including enrollments, patient status, resource
management, financials, and IRB activity. Patient tracking
tools include automated scheduling, screening, adverse
events and visit completion reports. The Web-based
software aids HIPAA compliance and simplifies trial
management with unlimited reporting capability. PerMedics’ software suite includes data capture solutions and
services.
eResearch Technology, Inc.
eStudy Conduct
PharmaTech Solutions, Inc.
An Internet-based technology to set up clinical trials, establish standards, track study activities, plan resources,
Patient Recruitment, Interactive Voice Response
Systems, Outcomes Research Implementation Support,
Consumer Affairs Support See Other Applications
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APPLIED CLINICAL TRIALS SUPPLEMENT
33
Propack Data
Web-Based Software Services
PMX(R) CTM Solution See Clinical Project Management
Wireless/Mobile Technology
Sierra Scientific Software, Inc.
Acumen Healthcare Solutions, LLC
Aris Global
Clinical Research Infomation Systemä (CRISä), v7.1
TracIt2k EDC System See Electronic Data Capture
ClinTALK
Aris Global
globalTRIALS See Trials Management/Administration
Enables companies to easily connect to other disparate
systems (e.g., CDMS, safety, financial, and other systems)
in order to share critical information in real-time.
ClinicalTrialsNet Inc.
Carevoyance Telematics
ClinTriNet See Data Collection/Management
Catalyst
The Clinical Research Information Systemä (CRISä), v7.1
provides a fully integrated, fully interactive application that
captures, archives, and reports data across the entire clinical enterprise. Supporting electronic or manual entry and
export of data, CRIS incorporates CDM, CTMS, materials
management, and safety data management and accelerated reporting functions
Dynarand
TrialTrac, Inc.
Integrated Study Management
SiteTrac
Dynrand's Interactive Voice Response (IVR) and Web-based
Systems provide integration of real-time data to simplify
project management, reduce human error, and save time
and money. Automated notifications and summary reports
provide the additional tools that make the systems an
optimal solution for study management.
SiteTrac is clinical trials management software tailored to
the needs of SMOs, research institutions, sites, and AROs.
It’s easy to use, quick to implement, customizable and
HIPAA compliant. Our integrated design is comprehensive,
and tracking includes patient information, essential
documents, investigator earnings and sponsor payments,
patient/study searching, and every step in between.
Velos eResearch
Velos eResearch is a transformational trial management
solution that supports investigators, study teams and
sponsors through the entire research process—including
protocol design, patient feasibility assessment, study
administration, project management and trial execution—
thus expediting the research process, enhancing quality
and improving access to data by integrating systems,
aggregating information and centralizing processes.
Validation
Interactive Investigators’ Meetings, online meetings, eLearning, and eCollaboration solutions for clinical research professionals delivered by clinical research professionals.
iMedRIS Data Corp.
iMedRis has designed a Web-based trials management
system that integrates with our Web-based IRB application.
Submissions, AEs, and updates all flow seamlessly
between each of the modules thus cutting time and paperwork for all. Sites also have ability to capture and export
data using our new Data Capture module.
ICTM, ILMS See Electronic Data Capture
Clinical IT systems implementation consulting See IT
MAJARO InfoSystems Inc.
Consulting
ClinAccess Web
PV-Works See Adverse Events
Coming this year, data entered via Web directly into SAS
datasets. Uses PDF, with online validation. Serves data back
(available dynamically as entered) for review, reporting. Data
clarification processing, including query resolution and tracking, with dynamic access to images. Easily combine data
from Web, OCR, and/or in-house entry.
DataCeutics, Inc.
Medidata Solutions, Inc.
IT Support and Services for the Clinical Research
Environment See IT Consulting
Medidata 4sight
Analyse-it Software, Ltd.
Analyse-it Clinical Laboratory See Statistical Analysis
Assured Information Systems
The EthIR LAN family brings PDA and laptop users the
immediate benefits of dedicated high speed network access
using popular software applications such as AvantGo, web
clippings, Eudora web browsing, E*Trade stock transaction,
email access, etc. Installation of the EthIR LAN into a
10/100 Base-T or 802.11b backbone for network access is
seamless due to its internal DHCP functionality.
iRIS (internet Research Information System)
LifeTree Technology
Advanced Systems Development
Clarinet Systems
EthIR LAN
ePharmaLearning
eMeetings, eLearning
Velos, Inc.
Using handheld PDAs, our turn-key solutions prompt
subjects to report data in real-time, while continuously
monitoring for adverse events and assuring trial protocol
adherence. Better quality data, reduced time to database
lock, and safe management of adverse events results in
expedited trials significantly reduced risk for our customers
and their subjects.
Clinitrac
Clinitrac Patient Diary, Clintrac Visit Diary See
Electronic Data Capture
ePocrates, Inc.
DocAlert(r) Messaging
ePocrates DocAlert(r) messaging program allows the
pharmaceutical industry a unique, effective method of
communicating their recruitment needs direct-to-physicians.
The messaging program works on a handheld device
platform and allows for bi-directional communication.
ePocrates is able to target your trial recruitment message by
physician specialty and geographic location.
invivodata, inc.
invivosystem See Data Collection/Management
Logos Technologies Ltd.
SMART Patient Diary Card
Honeywell/POMS
POMS CMS See Trials Management/Administration
Relsys International, Inc.
Argus Safety
Relsys International is the leading developer of specialized
software for managing product risk associated with pharmaceuticals and medical devices. The company’s software
solutions empower manufacturers to meet current product
safety regulations and internal quality objectives. Argus
Safety is the world’s top-selling global drug safety software
solution.
Medidata 4sight joins the core technology philosophy of
Medidata’s clinical research products with opportunities for
online communications packages for post-approval trials and
registries. Online newsletters, surveys, forums, and
downloadable or linked content (such as white papers, webcasts, and other resources) are prebuilt and ready for rapid
branding and deployment with trial-specific content.
Logos Technologies is a global provider of System Solutions
for Drug Research to the world’s Pharmaceutical and Clinical
Research Organisations. Our market leading products,
ALPHADAS and Smart Patient Diary Card have successfully
improved our clients study efficiency, provided compliant
data, achieved a faster database closure, as well as dramatically reducing cost. Logos Technologies prides itself on its’
high quality solutions which meet GCP & FDA regulatory
compliance such as 21 CFR 11.
Medidata Solutions, Inc.
NetRegulus
Medidata RAVE See Electronic Data Capture
ActivityAnywhere
OmniComm Systems, Inc.
TrialMaster See Electronic Data Capture
PerMedics, Inc.
SEC Associates, Inc.
Surveyor Trial Management System See Trials Manage-
Computer system compliance consulting
ment/Administration
SEC Associates provides system compliance consulting and
computer validation services for the pharmaceutical,
biotechnology, and medical device industries. SEC’s experienced consultants assist clients with regulatory compliance
assessments, vendor audits, 21 CFR 11 training, procedure
development, requirements analysis and planning, documentation, and execution of computer validation and life cycle
activities.
StudyBuilder Limited
Inside StudyBuilder See Training
ActivityAnywhere is a supplemental module to our ActivityExpert data collection and workflow management tool. It allows
users to record data using intuitive forms right at a field,
clinical trial, or manufacturing site using portable devices
such as Windows-based PC tablets or laptops.
PHT Corporation
LogPad See Electronic Data Capture
PharmaPros Corporation
NCompass See Data Collection/Management
StudyBuilder Limited
StudyBuilder Limited
Capture
StudyBuilder Enterprise Edition See Electronic Data
MyStudyBuilder.com
MyStudyBuilder.com ($4999 per quarter)
MyStudyBuilder.com is the one stop data hosting service for
studies designed with StudyBuilder software. Locate at
MyStudyBuilder.com and your study will have a private Web
site built and deployed on dedicated servers within a few
hours.
Vitalograph Inc
Electronic PEF/FEV1 Diary system See Electronic Data
Capture
Other Applications
Winchester Business Systems, Inc.
ComPac GxP
Velos, Inc.
ComPac GxP software from Winchester Business Systems is
the only complete 21 CFR 11 solution for Lotus Notes and
Domino. It allows an organization to make its existing or
future Notes Based applications 100% compliant with 11
regulations. ComPac GxP bolts on to the existing applications with minimal disturbance to the original code.
Velos eResearch See Trials Management/Administration
34
APPLIED CLINICAL TRIALS SUPPLEMENT
Vital Link.net
Vital Tracker See Electronic Data Capture
actmagazine.com
Clarinet Systems
EthIR LAN See Wireless/Mobile Technologies
Dynarand
Electronic Diaries See Electronic Data Capture
March 2003
Dynarand
Integrated Study Management See Web-Based Software
Services
PharmaPros Corporation
CRFTrack See Data Collection/Management
PharmaPros Corporation
DataVal
DataVal is a suite of flexible, validated, easy-to-use PL/SQL
programs for use in the design and development of edit
checks. Using DataVal can significantly reduce the effort in the
development and testing of edit checks, and increase consistency across studies for discrepancy management. DataVal is
integrated with Phase Forward’s Clintrial 4.
PharmaTech Solutions, Inc.
Patient Recruitment, Interactive Voice Response Systems,
Outcomes Research Implementation Support, Consumer
Affairs Support
PharmaTech Solutions is a Patient Management Organization
(PMO) serving the pharmaceutical and healthcare industry. We
pride ourselves on focusing on the patient in clinical and
commercialization programs. We provide services that accelerate enrollment of thoroughly qualified patients and maximize
patient compliance and retention. Our clinical and marketing
experts understand disease states, the challenges of enrolling
a clinical trial, the importance of collaboration with investigator
sites and our responsibility in educating and communicating
with patients.
SEC Associates, Inc.
Computer system compliance consulting See Validation
Wimmer Systems, LLC
DaCS (Data Compliance System) See Data
Collection/Management
March 2003
actmagazine.com
APPLIED CLINICAL TRIALS SUPPLEMENT
35