We design the perfect strategy to optimize your outcome.
We’re in the middle of a healthcare revolution, and no one knows exactly where we’ll end up. That’s why we’ve assembled a team of world-class experts to ensure you’re always headed in the right direction and can benefit from the latest insights and capabilities.
Our people are what make us great and, with experts in every major discipline, we understand today’s ever-changing drug development landscape unlike anyone else. No matter the scientific or medical complexities of the indication, the changing regulatory landscapes around the world, or the data and technological capabilities required to deliver ground-breaking virtual studies, we have the expertise to design the perfect strategy to optimize your outcome.Speak to our research experts today
A core aspect of the drug development landscape has been and always will be an intimate expertise in therapeutic areas. Our experts will partner with you to design protocols that not only ease the burden of participation, but use the latest advancements in scientific knowledge, data capture, and study design to help you achieve success.
Global Regulatory Affairs
Regulatory compliance is not just another box that needs to be checked off in the drug development lifecycle. The truth is, without strategic regulatory compliance, no drug makes it to market—and every drug in development that doesn’t make it to market means less revenue to continue research on other promising and life-changing molecules.
Pharmacovigilance & Patient Safety
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.
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…
Regulatory Technology Services
In our latest case study, PRA’s Regulatory Technology Services team discuss their understanding of drug regulation and the technology that supports…
Plain Language Summaries - Keeping the End in Mind: Key Considerations for Creating Plain Language Summaries
Plain language summaries (PLS), also known as lay summaries and trial results summaries, educate participants and the public about clinical trial…