Peri- and Post-Approval Services
Optimized patient access requires strong evidence of value, effectiveness and safety
Biopharmaceutical companies are needing more and more evidence to prove value and effectiveness in post-approval settings, including how to communicate this evidence to payers, health authorities and other decision-makers.
- Does the treatment improve patient outcomes and is it safe in the real world?
- Which patients will most benefit from the treatment?
- Is the treatment worth the price paid and does it deliver good value for the price?
Questions like these are just the tip of the iceberg when bringing a pharmaceutical, biotech or medical device product to market. Translating favorable pre-approval clinical trial results into success in the real world can be one of the most daunting parts of the product development process. Although the industry continues to witness advancements in analytical methods and technologies, gain greater access to novel data sources and develop new approaches to harness patient preferences and insight, the payer and regulatory evidence requirements are expanding. These stakeholders are seeking ever-increasing insight into the real-world impact and overall value of a product to both individual patients and the health care system at large.
Learn more about Thermo Fisher Scientific’s acquisition of CorEvitas
Peer-reviewed publications per year
Global payer submissions supported per year
Therapies per year where PPD has helped generate evidence to demonstrate safety, effectiveness and value
Developed evidence to reverse, fast-track and influence National Institute for Clinical Excellence (NICE) decisions across a variety of therapeutic areas
Forward. Faster. Further.
Today’s world of drug development is constantly changing. With an increase in patient engagement and empowerment, a rise in new real-world data sources and a shifting stakeholder and regulatory landscape, you need a way to break through the chaos to find clarity so patients can get what they need.
Evidera, PPD’s dedicated peri- and post-approval business, brings together innovative methodologies, cutting-edge technologies and unparalleled experts with a passion for creating solutions. With over 35 years of scientific rigor and operational expertise, we can help you take on Phase I to post-launch with unmatched efficiency and speed. Ready to move your product forward?
