We provide a comprehensive range of drug safety services to help minimize risk and protect patient well-being.
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them. From versatile technologies and targeted data collection and analysis to in-depth reporting and regulatory compliance, we provide a comprehensive range of pharmacovigilance services throughout the product life cycle to detect, assess, understand, and prevent adverse effects or any other drug-related issues, ultimately making patients’ lives better.
Watching out for you and your patients
Pharmacovigilance & Patient Safety
In our central repository of regulatory reporting requirements
With ten centralized Drug Safety Centers located throughout Europe, Asia, and the Americas, our global team works cross-functionally with other solution areas such as Real World Solutions and Therapeutic Expertise to help our clients effectively manage their drug safety information.
Our sophisticated yet versatile electronic data capture (EDC) system gathers and analyzes safety data so we can detect risks early. Critical safety information can be securely shared with regulatory authorities and other stakeholders instantaneously, and our electronic tracking system provides transparency of our compliance with global regulations during audits and inspections.
Pharmacovigilance and Patient Safety
PRA provides a comprehensive range of pharmacovigilance solutions for the entire product life cycle. We deliver flexible and customized services with…
Sponsor and CRO Pharmacovigilance Alliances
Outsourcing pharmacovigilance activities is a standard business practice in a continuously expanding market segment. In the past, outsourced safety…
Risk Management Services
PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify…
Aggregate Safety Reports
PRA Health Sciences (PRA) is dedicated to ensuring quality Aggregate Safety Reports are delivered to our sponsor and MAH partners. Our experienced…
A proactive and thorough approach to safety monitoring, profiling, and reporting
Well-planned data exchange and clearly defined responsibilities are essential in the development of safe medicines. Our approach to safety monitoring, profiling, and reporting enables us to identify potential safety concerns early and ensure compliance with today’s ever-changing regulatory environment.
We assign a Medical Director with specific expertise in the concerned therapeutic area to each project and offer trend analysis through signal detection and management and strengthened safety monitoring through our support of Data Monitoring Committees and Central Adjudication Committees. Our medical and safety experts continuously monitor and pinpoint potential safety concerns as early as possible to protect the security of your patients and the integrity of your product.
Our Safety Teams have extensive training and detailed guidance in the compilation of Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs). Each report summarizes relevant safety information, assesses safety scientifically, and evaluates benefits and risks in an integrated approach.
Meaningful, accurate benefit-risk management
We stay abreast of existing regulations and emerging trends and understand the current regulatory landscape and industry resource needs for iterative benefit-risk management. By leveraging our medical and scientific expertise from across our global teams, with our skilled project management and strict attention to quality control, we can assure high-quality delivery and regulatory compliance.Learn more about our Risk Management Planning capabilities.
Global Clinical Regulatory Services Newsletter
This quarterly eNewsletter will keep you informed of regulatory news and trends as it relates to the clinical development industry and insights from…
European Union Medical Devices Regulation: Electronic Labeling
The May 2017 release of a new MDR in the Official Journal of the European Union marked the start of a three-year transitional period within the…
A single product candidate that provides clinical benefit across multiple indications and patient populations allows more conditions to be treated…