Regulatory and Safety Management

Westat’s Regulatory Department collaborates with sponsors and in-house project staff to ensure that every regulatory aspect of protocol development, clinical trial management, and documentation complies with local, Federal, and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH) requirements.

Our regulatory staff have firsthand, in-depth knowledge of the regulatory requirements for the United States. We also provide regulatory support to multisite international trials and are familiar with the clinical regulatory requirements of Argentina, Botswana, Brazil, China, Costa Rica, Dominican Republic, India, Mexico, Panama, Peru, South Africa, Uganda, the United Kingdom, and others.

Services

  • Standing in-house institutional review board
  • Data monitoring committee (DMC) services’ support
  • Safety database management
  • Investigator brochure preparation
  • Preparation and submission of Food and Drug Administration (FDA) reports and filings, including
    • Investigational new drug (IND) applications
    • IND amendments
    • IND annual reports
    • IND safety reports
  • Regulatory review of protocols and informed consent forms
  • Preparation of template informed consent forms
  • Management of site establishment and protocol registration processes
  • Preparation and maintenance of Clinical Trial Master File in accordance with the Federal requirements and ICH Guidelines. Paper and electronic file maintenance with a full internal quality assurance audit prior to delivery
  • Electronic data archiving services through a proprietary archive tracking system

Site Information Management for Clinical Trials

Westat uses a proprietary tracking system, Site Information Management for Clinical Trials (SIMCT), to track all regulatory documents received for site establishment and protocol registration.

Adverse Event Reporting System

Westat uses Oracle’s Adverse Event Reporting System (AERS) to efficiently collect, maintain, track, and report serious adverse event (SAE) data. Data can also be reconciled with clinical databases. The system tracks event dates and provides prompts when reports are due.

AERS automatically populates two key forms from data entered into the system

  • Council for International Organizations of Medical Sciences (CIOMS I) form
  • Form FDA 3500A (MedWatch)

This task ensures efficiency and accuracy in form preparation. AERS meets Federal reporting requirements for investigational products, marketed products, and 21 CFR 11 electronic records.