Services

Westat provides a variety of services for clients seeking assistance with international projects in the clinical trials arena. We develop innovative information system solutions to facilitate the collection and analysis of data. Our solutions emphasize technological accessibility, user-friendly interfaces, comprehensive testing and certification, and ongoing user support and training.

Design and Development of Clinical Trials

  • Study design
  • Protocol design and development

Site Identification, Qualification, and Management

  • Site capability and readiness assessments (clinic, pharmacy, laboratory)
  • Site establishment and operations assistance (staffing requirements, study start-up, regulatory support, standard operating procedures development)

Training

  • Training and technical guidance of site personnel (good clinical practice [GCP], good laboratory practice [GLP])
  • Protocol-specific training of research team members
  • Training on data entry systems and data management processes

Site and Laboratory Management and Monitoring

  • Ongoing protocol execution support
  • Clinical trials site monitoring
  • Laboratory monitoring
  • Performance oversight and compliance support

Data Management

  • Assessment of data management capabilities and systems
  • Technical advice on improving data management processes and systems
  • Data management capability building, standardization, and harmonization
  • Data management plans and data collection/processing guidelines development
  • Data collection form design, printing, and distribution
  • Database design and validation
  • Data receipt (hard-copy or electronic forms), logging, and tracking
  • Data entry (single or double data entry)
  • Electronic data loading from laboratories and external sources
  • Data review, cleaning, and reconciliation
  • Medical coding
  • Study monitoring reports
  • Data delivery

Compliance

  • Guidance in support of compliance with U.S. and in-country human subjects protections regulations (ethics board reviews, informed consent)
  • Data monitoring committee (DMC) 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 plans development
  • Statistical programming and validation
  • Statistical analysis assistance
  • Statistical report and manuscript preparation