Arkivum has announced a partnership with PHARMASEAL, provider of the Engility® Trial Management Platform, which integrates a Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF). The collaboration incorporates Arkivum’s GxP-validated digital archiving and preservation technology into PHARMASEAL’s platform, supporting long-term compliance and regulatory inspection readiness.

The partnership enables sponsors to address data retention requirements from the outset of a clinical trial rather than post-study closeout. PHARMASEAL customers using the Arkivum solution can maintain essential trial records and data in alignment with industry good practice outlined in ICH E6 (R3) and retention regulations such as EU CTR.

Chris Sigley, CEO of Arkivum, said: “We’ve been aware of the work that PHARMASEAL has been doing within the clinical trial space and I am now delighted to be able to officially call them a partner. This partnership will increase awareness of the importance of a fit-for-purpose solution to preserve all essential clinical trial records and data.”

Ricky Lakhani, chief product officer at PHARMASEAL, added: “This partnership ensures our customers have a robust, long-term solution for data retention, guaranteeing that critical clinical trial records remain accessible, compliant, and usable for decades to come. This collaboration future-proofs data integrity, allowing our customers to meet evolving regulatory requirements and confidently leverage their valuable information long after a trial has concluded.”

By combining Arkivum’s validated digital archiving with PHARMASEAL’s unified platform, the solution aims to support inspection readiness, long-term record accessibility, and adherence to regulatory requirements.

MASEAL’s unified platform, the solution future-proofs trial data integrity and supports inspection readiness, helping sponsors meet evolving regulatory requirements confidently.