Egnyte, a leader in cloud content security and governance, has announced Egnyte for Life Sciences eTMF, a new product for the clinical development functions at life science companies to manage trial master file data. Egnyte for Life Sciences eTMF is 21 CFR Part 11 compliant solution that reduces document processing time while maintaining compliance and audit readiness.
With the new solution clinical development professionals can easily create an eTMF to manage the thousands of documents collected through a trial and ensure they are properly stored, managed, and audit-ready. The can also can apply automation and artificial intelligence to monitor misindexed documents, sensitive personal information and protect against potential ransomware attacks.
“In the US alone, the number of registered studies this year has already surpassed the high-water mark set in 2020, and we have not even entered the fourth quarter,” said Ramin Farassat, Chief Product Officer, Egnyte. “Designed to meet the needs of the growing class of emerging and midsize biosciences companies, our eTMF solution will alleviate the data management burdens associated with trial studies, so that clinical teams can focus on their core mission – getting safe and effective treatments to market quickly.”
Thesolution enables clinical development professionals to:
- stay on track with milestones: built on Egnyte’s leading secure collaboration platform, get full visibility into study milestones, allowing clinical teams to communicate with sites to stick to timelines.
- Maintain control of trial information: the governance features allow teams to flag missing source documents, leverage AI and ML features for constant monitoring for misclassified documents or embedded PII/PHI
- Be audit-ready and compliant: meeting GxP and FDA 21 CFR Part 11 requirements, Egnyte allows companies to stay audit-ready and maintain compliance in a cloud-based solution.
- Accelerate TMF creation: eeduce the administrative burden for clinical teams to stay organised with predefined reference models and standard artifacts.