Site Management and Monitoring

For over 20 years, Westat has provided experienced and well-trained clinical trials managers and clinical research associates (CRAs) to support implementing and monitoring Phase 1 through 4 clinical trials.

We have extensive training requirements for our project managers and CRAs, including both internal and industry-accepted training programs. Internal training courses and seminars help keep staff updated and continually refreshed on regulatory requirements, good clinical practice (GCP) guidelines, and effective industry practices. In addition, Westat’s clinical trials staff are required to certify annually on Human Subject Protections requirements.

Site Management

Site management activities are supported by Westat’s in-house CRAs, as well as the CRAs assigned to monitor specific studies. Staff assigned to a project receive project-specific training to ensure they can provide accurate and consistent information to the sites.

Services

  • Identifying, qualifying, and selecting sites
  • Negotiating site contracts and budgets
  • Managing site payments
  • Supporting sites in local or central IRB/IEC submissions
  • Organizing and conducting investigator meetings
  • Designing/producing training materials and tools to support study execution (procedures manuals, regulatory and pharmacy binders)
  • Conducting site training
  • Establishing/maintaining toll-free help lines with 24/7 access
  • Tracking/documenting project communications for Trial Master File compliance
  • Providing sites with regular study updates (newsletters)
  • Coordinating/tracking custom materials (study drug, specialized lab kits, case report form binders and supplemental forms) and shipment of lab specimens

Site Monitoring

Westat’s monitoring CRAs have experience in a wide range of therapeutic areas and phases of study. We have a large pool of well-trained, experienced monitors, including monitors based at our headquarters, throughout the United States in regional sites, and international in-country monitors.

Westat has developed a web-based site monitoring, tracking, and reporting system to ensure our monitors have ready access to vital information during their site visits. Detailed, comprehensive site visit reports are prepared following each visit and provided to clients to keep them abreast of the findings.

Westat’s Quality Assurance (QA) team regularly conducts QA monitoring visits to ensure our CRAs are adhering to Westat’s standard operating procedures.

Monitoring Services

  • Conducting clinical site monitoring visits (qualification, initiation, interim, pharmacy, and closeout)
  • Conducting GCP and good laboratory practice (GLP) audits
  • Monitoring analytical laboratories