By now, it’s no secret that good clinical practice (GCP) guidelines used by FDA inspectors are expanding. These GCP guidelines are developed by the International Conference on Harmonization. The ICH last revised its GCP document, called ICH E6(R2), in 2016. It will be releasing a new version in August 2023. The FDA calls these “Guidances” once they are implemented.

The primary reason for this revision by ICH is to ensure patient safety and data integrity amid the growing volume of diverse data sources and study types, such as adaptive clinical trials, trials using master protocols, and decentralized clinical trials. Health authorities are concerned that this diversity introduces new risks. They want to ensure these risks don’t outweigh the benefits of new drugs and medical devices.

Some leaders in clinical research have already adopted the cutting-edge technology needed for clinical teams to optimize the drug development process and meet the guidelines articulated by ICH E6(R2). Others still struggle to get a comprehensive view of clinical trial risk. A modern clinical trial management system (CTMS) is pivotal to helping clinical teams make operational changes to follow the GCP guidance.

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