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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.
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.
Key components of Early Phase Clinical Development
Integrated study design affects later 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.
- Integrated early phase services:
bioanalytical lab, ECG core lab, and imaging core lab
(all wholly owned subsidiaries)
- Experience conducting phase I studies across key therapeutic areas, including first-in-human, as well as patient and special populations
- Experts in cardiac safety
- End-to-end approach to study design assists in predicting late phase research outcomes
- Early phase services including regulatory consulting, protocol design and writing, pharmacokinetic and translational medicine consulting, project
management, data management, and clinical study report writing
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.