Medpace uses our global operational reach and full service capabilities to help you achieve your scientific and commercial objectives. A highly qualified team of executives and specialists leads our Real World Evidence (RWE) and Late Phase Research efforts with years of clinical, observational, and economic research experience.
Plan Early for Late Phase
As the market access landscape continues to evolve, the timing of RWE and Late Phase Research is becoming increasingly important. Drawing upon our experience and expertise, Medpace can help you determine the best timing for initiating analyses earlier in the product development cycle and planning for later phase and post-marketing analyses. Whether it be earlier or later in the development cycle, Medpace can generate relevant evidence through the design and execution of prospective and retrospective observational studies including registries, safety studies, and expanded access programs. In addition, Medpace also has the capability to conduct standalone or piggyback economic analyses, such as cost-minimization and cost-effectiveness analyses, budget impact modeling, and evaluation of health-related quality of life (QOL) and other patient-reported outcomes (PROs).
RWE and Late Phase Capabilities
- Expertise, resources and infrastructure to conduct earlier phase trials while designing and implementing plans for RWE and late phase research in support of your product
- Develop post-approval strategies that are well-integrated with early-stage clinical development plans
- Medical, regulatory, clinical, and RWE and late phase experts are deeply embedded in your studies to provide strategic and operational leadership
- Breadth of resources to conduct global research yet an agile culture that enables rapid 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 RWE and Late Phase studies:
- Late phase randomized clinical trials (IIIb and IV)
- Observational epidemiologic studies
- Registries
- Post-authorization safety studies
- Expanded access programs
- Health economics and outcomes research
- Competitive marketing claims studies
