Cardiac Safety/TQT White Papers & Case Studies

  1. Considerations When Selecting A CRO For Phase I Clinical Studies

    Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

  2. Advances In Electronic Data Capture Of Medical Data

    Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells

  3. Phase II Primary Insomnia Program In Need Of Full-Service CRO Management

    Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.

  4. Examining Rescue Studies

    The purpose of this whitepaper is to define a Rescue Study, outline the basic assumptions, including risks, in setting up such a trial based on DATATRAK’s prior experiences, and present the actions that can help avoid or mitigate these risks during a deployment.