Article | October 1, 2024

Building Successful Studies: A Proven Framework

Source: OpenClinica

By Rajeshwari Jakkam

GettyImages-1443965506 doctor clinical trial data monitoring

In a notable session at the annual OC24 user conference, titled "Building Successful Studies: A Proven Framework", OpenClinica experts detailed a comprehensive approach to study design, encapsulating seven key themes:

  1. Guiding principlesOf Study Design
  2. Study personas
  3. Core design
  4. Libraries
  5. Testing
  6. Scoping and managing timelines
  7. And amendments.

The article also delves into the importance of efficient study planning and the utilization of eCRF libraries to enhance study quality which was explored in-depth in this session. Furthermore, OpenClinica recommends an easy-to-follow process for post go-live (PGL) amendments, emphasizing thorough documentation, configuration, testing, and stakeholder sign-off before production deployment.

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