Effective post-marketing pharmacovigilance

Post-marketing pharmacovigilance programs remain a vital part of any biopharmaceutical company’s overall risk management strategy.  Because Phase III clinical trials typically enroll no more than a few thousand patients, they cannot answer every question about a product’s risks and side effects, such as:

• Are there rare events that will only manifest themselves when more people use the product? 
• Are there specific risks for certain populations, such as younger or older people, or those with other conditions? 
• Are the risks different if a drug is taken over a long period of time for a chronic condition?

Phase IIIb and Phase IV post-marketing pharmacovigilance programs typically monitor the use of a product in a larger population and over a longer period of time – gathering data on reported adverse events and other safety concerns to ensure that a product’s benefit/risk profile remains acceptable.  Many biopharmaceutical companies are also bolstering their pharmacovigilance efforts by expanding their Phase IIIb clinical trial programs, which are conducted during the regulatory review process.  This approach gives companies the opportunity to gather additional safety and efficacy data – allowing them to gain a greater understanding about their products’ characteristics in real-world settings so they can work with the agency throughout the review process to refine a product’s safety profile. 

PAREXEL has extensive experience in Phase IIIb and Phase IV trials, as well as other post-marketing studies such as non-interventional trials and patient registries.  Our experience encompasses a wide range of therapeutic areas, patients, and trial sites around the world.  In just the past three years, we have been involved in more than 220 Phase IV studies enrolling more than 330,000 patients at 29,000 sites across the globe.  PAREXEL also has specific regulatory expertise in pharmacovigilance, including the European Union Risk Management Plan (EU-RMP) and the FDA’s guidances on Premarketing Risk Assessment, the Development and Use of Risk Minimization Action Plans (RiskMAP), and Good Pharmacovigilance Practices.

Equally important, PAREXEL offers its pharmacovigilance partners a comprehensive suite of eClinical technologies that are essential to the efficient and cost-effective operation of large post-marketing studies.  In short, we have the proven people, processes, and technology to help your company meet the unique challenges of large, late-stage pharmacovigilance trials.