Safety and Risk Management

SAFETY & RISK MANAGEMENT
SAFETY & RISK
MANAGEMENT
Minimizing patient risk is crucial as we work with sponsors to bring new products to the
marketplace. Now more than ever, regulatory authorities emphasize the importance of
a comprehensive safety infrastructure. The development of risk minimization strategies
suitable for the whole life cycle of the project is imperative. That’s why PRA Health
Sciences provides a comprehensive range of pharmacovigilance solutions for the entire
product life cycle. We deliver flexible and customized services with the ultimate goal
of minimizing risk and protecting patient safety. We work in a cross-functional fashion
with other solution areas, such as Post Marketing and Therapeutic Expertise, to better
assist clients with the effective management of their drug safety information.
EXPERIENCE
EXPERTISE
N o. OF SAFETY & RISK MANAGEMENT
PERSONNEL
200+
6
60+
For 20+ years, PRA has provided comprehensive pharmacovigilance services across all phases and key
therapeutic areas. Clients who choose PRA acquire not only additional safety personnel, but also a
dedicated, nimble team fully concerned with their needs and patient safety, while providing the proven
knowledge and therapeutic experience required to ensure quality data.
PHASE 1
PHASE 3
PHASE 4
occurs once
occurs at nonspecified intervals
PV/Risk Management Plan
SAE/ADR/MDR Management
Medical Monitoring
N o. OF DRUG SAFETY CENTERS
N o . OF COUNTRIES IN OUR CENTRAL
REPOSITORY OF REGULATORY
REPORTING REQUIREMENTS
PHASE 2
Definition of Safety Profile/
Benefit-Risk Assessment
Development Safety Update Report
Data Pooling/Data
Monitoring Board
Pooled Analysis
Integrated Analysis
of Safety/Efficacy
Periodic Safety Update Report
Post-Authorization Study
occurs throughout
occurs at specified
intervals
I N N O VAT I O N
WE ARE
DEDICATED TO
MINIMIZING RISK
AND PROTECTING
PATIENT SAFETY
• Investment
protection
• Meaningful
products
• Cost-effective
safety services
• Multiple levels of
accountability
• Global process
improvement
initiatives
• Customized, holistic
management
solutions
“Globally deployed, our teams deliver
expert services with local knowledge.
Our understanding of local cultures and
their nuances helps us dig deeper and more
effectively identify adverse events – some
of which might go unreported without this
awareness. We are committed to ensuring
the highest levels of patient safety."
SABINE RICHTER,
VP, Safety & Risk Management
• Comprehensive
safety infrastructure
• Nimble problemsolving approach
• Sophisticated,
versatile systems &
data analysis
Philadelphia
USA
Charlottesville
USA
• Global teams, local
safety knowledge
• Phase I-IV regulatory
expertise
• Highly experienced
in pharmacovigilance
standards & practices
• Operational solutions
& efficiencies
• In-depth patient care
& safety program
• High-quality data
Swansea
UK
Mannheim
Germany
S ingapore
Asia
São Paulo
Brazil
From the patients and their families who expect effective
medicines, to sponsors striving to develop meaningful
disease treatments, and finally to our team of professionals
who tirelessly scrutinize these products to assure their
safety – it’s all about people. PRA's global teams focus on
product safety every day. While collecting and analyzing
real-world data, we are mindful of the millions of people
that our work touches. The skills and dedication of our
scientists and safety experts are unparalleled – and patients
deserve nothing less as we work to mitigate and minimize
risk in the use of innovative therapeutic products.
Pharmacovigilance demands more of us than just collecting
the most comprehensive data and meeting the expectations
of clients and health authorities. To fully understand
what it takes to protect the public, we have to know and
appreciate where they call home. Our people understand
the nuances and foundations of each country’s culture,
customs, and standards of medical practice. This knowledge
enables us to make quality, ethically informed decisions
that help keep patients safe.
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.