Regulatory and Safety Management

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 the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH) requirements. Our regulatory staff has firsthand, in-depth knowledge of the regulatory requirements for the United States.

Services

  • Standing in-house institutional review board
  • Data monitoring committee (DMC) services’ support
  • Preparation of informed consent forms
  • Safety database management
  • Investigator brochure preparation
  • Food and Drug Administration (FDA) reports and filings preparation
  • Investigational new drug (IND) preparation and submission
  • Annual reports for INDs
  • Safety reports for regulatory agencies
  • Management of site establishment and protocol registration processes
  • Preparation and maintenance of Clinical Trial Master File

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.

The SIMCT system performs the following:

  • Allows for frequent status checks and report generation by protocol or site.
  • Prompts Westat staff when documents are outstanding or are approaching expiration and renewals are required.
  • Tracks all site monitoring activities.

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 also 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.