International Services

Westat provides a variety of services for clients seeking assistance with international projects in the clinical trials arena:

Design, Development, and Management of Clinical Trials

  • Study design
  • Protocol development

Site Identification, Qualification, and Management

  • Site capability assessments (pharmacy and laboratory assessments)
  • Site establishment and operations assistance (data management systems, laboratory and pharmacy readiness, regulatory and training support, standard operating procedures development)

Training

  • Training and technical guidance of site personnel (good clinical practice [GCP] and good laboratory practice [GLP])
  • Protocol-specific training of research team members

Site and Laboratory Management and Monitoring

  • Ongoing protocol execution support
  • Clinical trials site monitoring
  • Laboratory monitoring

Data Management

  • Data management and data quality management plans development
  • Database design and validation
  • Data collection
  • Statistical programming and validation
  • Information management assistance

Compliance

  • Human subject protection and regulatory guidance
  • Data and safety monitoring board (DSMB) establishment, management, and reporting
  • Investigational new drug (IND) application preparation and submission
  • Adverse event monitoring and filings
  • Serious adverse event (SAE) database development and management

Quality

  • Quality assurance (QA) procedures development and monitoring
  • Clinical site auditing

Statistical Analysis

  • Statistical analysis assistance
  • Statistical report and manuscript preparation