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Trials Management Services
Trials Management Services incorporate the design, management and
implementation of study protocols, the critical building blocks of product
development programs. PRA has extensive resources and expertise to design
and conduct studies on a global basis, develop integrated global product
databases, analyze the data, and prepare and submit regulatory submissions
in Europe and the U.S. A typical Trials Management Services project may
involve the following components:
- Protocol and Case Report Form (CRF) design
- Feasibility study
- Project management
- Investigator site selection and qualification
- Investigator handbook and meetings
- Investigational site management
- Investigational site monitoring
- Medical monitoring and drug safety
- Data management
- Analysis and reporting
- Medical and scientific publications
- Regulatory filings
Trials Management Services are used by all sponsors—large, small,
domestic or foreign—and may be performed exclusively by PRA or in
collaboration with the sponsor's internal staff or other CROs. PRA has the
ability to conduct single-site studies (Phase I - IIa), multi-site domestic
studies, and international studies in North and South America, Europe,
Africa, Asia, and Australia.
Page last updated:
19 June 2008
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