Here at SCOPE, we have developed our own Clinical Trial Management System (CTMS) – InSIGHT. It is designed to enhance the efficiency of planning, tracking, and managing clinical trials, transforming data into actionable knowledge to support quicker and more informed decisions throughout the trial process.

As we are constantly working to improve our system, we’ve got some news!

Enhanced RBQM (Risk-based Quality Management)

▫ In order to achieve a holistic overview of the study data for RBQM, a “Data Hub” platform was created for the data exchange of all systems involved.

▫ Protocol deviations (PDs) can now be managed with more focus on importance. All user groups involved (CRA, PM(A), MM, Sponsor) are guided through a convenient workflow from CRA entry to final data review meeting.

▫ Protocol deviations can also be detected by Clinical Data Management based on various sources like eCRF and eDiary. Programatically observed deviations are imported to InSIGHT PD Management behind the scene and can be followed up within the same convenient workflows used for manually detected PDs.

What does this mean for you?

RBQM is all about focus on importance and overview is the key to unlock that door. Having all the data in one place makes it much easier to manage it.