SUCCESSFULLY EXECUTING GLOBAL STUDIES TO MEET PAYER AND REGULATOR REQUIREMENTS
To achieve optimal market access and effectively commercialize a new therapy, you must demonstrate the effectiveness, safety and value of a treatment in a real-world setting. Robust study design, therapeutic area insights and expertise, patient and data access, and precision study execution are necessary components for study and program success.
PPD specializes in evidence, value and access, through our Evidera business, We combine a deep understanding of the peri- and post-approval environment with decades of experience in global product development, spanning early stage, product launch and post-approval evidence generation to meet the requirements of payers and regulators alike.
Over the past five years, we have conducted:
AN EVOLVING SAFETY LANDSCAPE
Customized studies designed by dedicated experts
Our experts provide the deep expertise and access to worldwide patient populations that are essential for real-world study success. Our dedicated real-world, non-interventional study operations, regulatory and global clinical supply teams bring a wealth of knowledge and extensive experience to each project including:
- Teams across Europe, North America and Asia with over 25 years of experience
- Specialist medical affairs team that exceeds industry benchmarks in study startup and patient recruitment time
- Experience in most therapeutic areas and capabilities across a wide range of indications with extensive experience in pain/opioids, oncology, cardiovascular disease and ophthalmology
- Expertise in study design, protocol development and optimization, with all studies governed by a scientifically robust protocol that is reviewed and quality controlled by an in-house, industry-recognized research team