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Preliminary Product Assessment
Clinical Trials Management
Data Management
Biostatistics
Regulatory and Safety
IVRS: Clinical Logistics and Tracking
Global Services
Related Health Services

Regulatory oversight of all aspects of clinical development is critical to the successful implementation of clinical trials. Westat's Regulatory Department collaborates with sponsors and in-house project staff to ensure that every aspect of protocol development, clinical trial management, and documentation complies with local, Federal, and ICH requirements. Our regulatory staff, with extensive FDA experience, have firsthand, in-depth knowledge of the regulatory requirements for the United States. European and Asian affiliates provide expert oversight for regulations governing international studies.

Services:

  • Standing in-house IRB
  • IRB/ethics committee submissions
  • DSMB establishment, management, and reporting
  • Preparation of informed consent
  • IND preparation and submission
  • Preparation and maintenance of drug/biologic master file
  • Adverse event monitoring and filings
  • SAE database management
  • Package insert preparation
  • Preparation of FDA reports and filings
 
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