Bioanalytical Laboratories

B I O A N A LY T I C A L L A B O R AT O R I E S
BIOANALYTICAL
LABORATORIES
At PRA Health Sciences, we recognize that the world of clinical development is
complex and dynamic, and we’ve designed our bioanalytical laboratories to meet
those challenges. Proactive with our science and always looking to the future, we
provide the technology, innovative approaches, and high scientific standards
required to deliver industry-leading laboratory services.
“The proximity of our labs
to our clinics allows us to
handle the most time-critical
sample analysis.”
PETER KETELAAR,
Vice President,
Bioanalytical Laboratory Services
EXPERIENCE
PRA’s GLP-compliant laboratories are strategically
located close to our Phase I Clinical Research
Centers to foster innovative cross-functional team
collaboration and to facilitate rapid analyses of
time-critical samples. Our early phase environment
enables clients to advance studies to the next
phase much faster and clearly differentiates our
bioanalytical laboratories and clinical pharmacology units as centers of excellence.
EXPERTISE
N o . O F YE A RS P ROVI D I NG
B IO A N ALYTI CA L SE RVI CE S
30
2
25
PRA’s bioanalytical laboratories are managed, staffed, and supported by industry-leading experts
who have the scientific knowledge and experience necessary to successfully deliver the most
complex of studies.
G L OBA L P K / P D B IOA NA LY T IC A L S E RV IC E S
Laboratories in the US and The Netherlands
• harmonized
• GLP compliant
• Watson LIMS
Close to Phase I clinics to facilitate complex adaptive trials
Pharmaceutical analysis at QC lab for drug manufacturing
Isotope analysis to support human ADME study designs
N o . O F G L OB A L HA R MONIZED
B IO A N ALYTI CA L LA B S
A SSEN, NL
L E NE XA, U SA
N o . O F LC -MS/ MS MAC HINES
small
molecules
Flow Cytometry laboratory to evaluate early efficacy
Cell-based assay lab to demonstrate immunogenicity
1,000+ validated methods
I N N O VAT I O N
We provide analytical capabilities for small and large molecules supporting
GLP pre-clinical and Phase I-IV clinical trials. Our GLP-compliant facilities
adhere to the latest stringent global regulatory guidelines (e.g. FDA and
EMA) and expectations. Our technology investments and innovative
service offerings are a key component of our goals and strategies for
developing solutions for our clients.
SERVICE OFFERINGS
OUR
SCIENTIFIC
EXPERTISE
MAKES THE
COMPLEX,
SIMPLE.
Biohazard laboratory to handle infectious samples
LARGE
MOLECULES
LC-MS/MS, including ABSciex 6500
HPLC & UPLC Equipment
Ligand Binding Assays
Clinical Chemistry Laboratory
(Stimulation assays, enzymatic activity)
Flow Cytometry Unit
Radioisotope Laboratory
Biohazard Laboratory
PK of Small Molecules
PK of Large Molecules
Immunogenicity Assays
Biomarker/PD Assays
GMP Pharmaceutical Analysis
Co-located with PRA Clinic
EUROPE
NORT H A M ERICA
Global
Facilities
Our harmonized
global facilities
enable our
clients who
use both
of PRA's
bioanalytical
laboratories
to benefit from
transferring
assay methods
(small and large
molecules)
between
Europe and
the US.
No one understands the daily pressure
of tight deadlines better than the
people who depend on and help drive
clinical drug research – from the
millions of patients worldwide to the
devoted scientists who work tirelessly
on their behalf. At PRA, our bioanalytical
laboratory teams know that in today's
environment, a spared moment could
mean a missed opportunity to get even
a step closer to advancing meaningful
treatments to market.
To maximize time in early phase clinical
research, we have located our laboratories
near our Phase I units and developed
harmonized operating procedures
with all of our early stage clinics.
We are motivated by the role we
play helping to get safe and
effective treatments to patients.
And we are inspired knowing
that with our clients, we are
giving patients more time
to spend with loved ones.
PRA
PRA Health
Health Sciences
Sciences conducts
conducts comprehensive
comprehensive Phase
phase I-IV
I-IV biopharmaceutical
biopharmaceutical drug
drug development.
development.
To
To learn
learn more
more about
about our
our solutions,
solutions, please
please visit
visit us
us at
at prahs.com
prahs.com or
or email
email us
us at
at prahealthsciences@prahs.com.
prahealthsciences@prahs.com.