Planning for and Conducting Real World Evidence (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 real world and other late phase studies in both pharmaceutical and medical device areas. Our global operational reach and
full-service capabilities for clinical and observational research can help
you achieve your scientific and commercial objectives.
How our RWE and late phase research team can help:
- Expertise, resources and infrastructure to transition from randomized controlled trial process to the development and implementation of a plan for RWE in support of your product
- Develop post-approval strategies that are well-integrated with your early-stage clinical development plans
- Medical, regulatory, clinical, and RWE/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
Medpace conducts both interventional and non-interventional type studies:
- Late phase randomized clinical trials (IIIb and IV)
- Observational epidemiologic studies
- Health economics and outcomes research
- Post-authorization safety studies
- Competitive marketing claims studies
- Expanded access programs
Medpace's RWE 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).
Listen to Lee Walke,VP eClinical and Matt Page, Epidemiolist, explore the application of pharmacoeconomic assessment throughout all phases of clinical trials as well as in observational studies, including registries and other post-marketing data collection.
Pharmacoeconomic Assessment through Market Approval and Beyond: Theory and Operations from Medpace CRO.
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 .