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Phase I

Early Phase Clinical Development

Early Phase Clinical Development sets the course for a long and trusted relationship. Learn more about the benefits and capabilities of Medpace Clinical Pharmacology Unit and Medpace Bioanalytical Laboratories.

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Medpace Early Phase Services - Phase I-IIa

Pressure to contain the rising costs of drug development continues to force biopharmaceutical sponsors to find ways to inject efficiencies into the R&D process. As a result Early Phase study design and its effect on predicting late phase research outcomes is becoming critical. Bringing promising compounds from the lab to the patient earlier in the development phase requires a partner with comprehensive early stage expertise and capabilities. Using new techniques involving translational medicine, adaptive studies, and integrated strategies in Early Phase study design can be effective study design components – identifying compound issues early on – potentially eliminating large expenses associated with late phase projects.

Integrating Key components of Early Phase Clinical Development

Integrated study design

Integrating study design affects late stage studies and requires a mastery of different disciplines working together to pull off bench to bedside science in an effort to find answers more quickly. Managing components of Early Phase studies require expertise across a number of disciplines-therapeutics, regulatory, biometrics, and laboratories, requiring a CRO with full-service global capabilities in these areas for early phase success.

Translational Medicine

Termed Translational or “bench to bedside” medicine -the concept forms initial basis for evidence-based practice and clinical guidelines. In the case of drug discovery and development, translational research typically refers to the translation of non-human research finding, from the laboratory and from animal studies, into therapies for patients. Medpace Early Phase uses many facets of translational medicine to facilitate the interaction between basic research and clinical medicine to design and conduct clinical trials. This thoughtful design of studies in the Early Phase translates to efficiencies though-out late Phase studies, effecting success rates of bringing promising compounds to a successful NDA.

Full-service Capabilities

The Medpace team of therapeutic experts across all operational disciplines, with the support of wholly owned clinical pharmacology unit with telemetry, central laboratories, bioanalytical capabilities, core imaging, and cardiovascular core labs can deliver innovation in study design using these techniques, supported by a full service global clinical research organization known for therapeutic focus.