Planning for and Conducting RWE and Late Phase Clinical Research
Medpace, long known for its therapeutic and regulatory capabilities, is well-resourced to assist with your post-approval strategies and to conduct
late phase studies in both pharmaceutical and medical device areas. Our global operational reach and
full-service capabilities for clinical research can help
you achieve your scientific and commercial objectives.
How our epidemiology and late phase research team can help:
- Develop integrated post-approval strategies with your early-stage clinical development plans
- Medical, regulatory, clinical, and late phase experts are deeply embedded in your studies to provide strategic and operational leadership
- A breadth of resources to conduct global research yet an agile culture that enables swift adaptability as study requirements shift
- Targeted site selection reflecting real world drug and medical device use
- Dedicated submissions team to accelerate startup
- Global and localized regulatory leadership from early phase through late phase
- Expertise, resources and infrastructure to transition from randomized controlled trial process to real-world implementation
Medpace conducts both interventional and non-interventional type studies:
- Phase IIIb and IV randomized clinical trials
- Observational epidemiologic studies
- Health Economics and Outcomes Research
- Post-authorization safety studies
- Competitive marketing claims studies
- Expanded access programs
Medpace's epidemiology and late phase research team engages with The European Network of Centres for
Pharmacoepidemiology and Pharmacovigilance (ENCePP), and the International Society for Pharmacoeconomics and Outcomes
Research (ISPOR). Being a partner centre of the ENCePP, Medpace is able to register appropriate studies we
conduct on the ENCePP e-register, a publicly accessible resource for the registration of pharmacoepidemiological
and pharmacovigilance studies, which also serves as an EU PAS Register for Post-Authorization Safety Studies (PASS).
Registry Planning and Implementation
Listen to Derenda Nichols,Director of Clinical Trial Management, address factors that contribute to successful Registries. The presentation was recorded at the CBI Real World Data/Late Phase Research Summit.
Registry Planning and Implementation: An Operational Perspective from Medpace CRO .