Observational Research

Late Phase Clinical ResearchReal World and Late Phase Evidence

Pharmaceutical, medical device, and biotech companies increasingly must demonstrate evidence of real world outcomes in order to differentiate their products in a saturated and competitive healthcare marketplace, which includes regulators, third party payers, healthcare providers and patients.  Proving safety and efficacy before product launch alone is not enough to remain profitable while satisfying the additional scrutiny and demands of healthcare stakeholders.

At Medpace, we understand the differences and similarities between interventional trials and observational studies. Medpace integrates our strong therapeutic leadership with an in-depth understanding of the challenges and proper conduct of observational research studies.  We demonstrate a commitment to excellence in this area with a leadership team dedicated exclusively to Real World Evidence and Late Phase Research.  With over 100 years of combined research experience, 50 of which have been dedicated exclusively to late phase and observational research, this team is recognized for its expertise and leadership.  They provide hands-on work, guidance, and counsel for every observational study at Medpace.  Medpace has also developed guidelines governing every element of observational research and proprietary technology built specifically for observational studies.

Medpace Has Extensive Experience Designing and Conducting:

  • Observational epidemiologic studies (e.g. natural history, retrospective claims analyses, chart reviews)
  • Registries
  • Expanded access programs
  • Post-marketing requirements and commitments
  • Post-authorization safety studies

Medpace Real World Evidence and Late Phase Research Hybrid Study DesignHybrid Study Design

An element of late – and early – phase research in which Medpace has developed particular expertise is the hybrid prospective-retrospective study design.  Such a study design merges retrospective and prospective data to save time and money in the evaluation and assessment of investigational as well as marketed pharmaceuticals, biologics, and medical devices. Medpace has designed processes and procedures for such studies and implemented them with Sponsors.