Almac Clinical Technologies, a member of the Almac Group and global provider of Interactive Response Technology (IRT) for the biopharmaceutical industry, has launched the OVERSIGHT Trial Data Integrity Monitoring System, available as an add-on suite to the company’s IRT platform, IXRS.

The OVERSIGHT system provides on-demand visibility to the data history of kits, subjects and sites within the IXRS—enabling sponsors to identify data integrity issues through audit trail reviews before they can impede a study. It was developed in direct response to new regulations, namely—guidance from the MHRA, FDA and 2021 draft guidance from the EMA—that has expanded the responsibility and accountability of sponsors in maintaining trial data integrity.

Using OVERSIGHT, sponsors are empowered to proactively flag negative trends and performance outliers to keep studies compliant and audit-ready 24/7. It allows on-demand access to study data to identify risks, via quick and easily digestible summary and detailed data views, and filtering capabilities, to support Sponsors with their processes and procedures around periodic review and risk identification and remediation.

“The audit trail is an integral part of any e-clinical system and should be utilized as a tool to drive data reviews forward,” said Cheryl Kole, head of solutions strategy and commercialization, Almac Clinical Technologies. “Using OVERSIGHT, sponsors can take control of data integrity considerations at a critical first point of entry, before potentially discrepant data is pushed to downstream systems.

“As both regulatory guidance and technology capabilities continue to evolve, both systems and processes must stay up to speed. Almac is committed to helping sponsors navigate evolving regulations and we’re excited to offer OVERSIGHT as a proactive solution to keep studies compliant and audit ready, minimizing the risks of impeding studies and impacting patients who rely on receiving the right medication at the right time.”