Case Study: Neuraly achieves GCP-compliant eTMF archiving with Arkivum

Neuraly becomes GCP compliant with Arkivum for 2 Phase II studies

Neuraly, a clinical-stage biotechnology company, faced the challenge of archiving its electronic trial master file (eTMF) to meet Good Clinical Practice (GCP) compliance. They needed a solution to safeguard data from loss or corruption, ensure it remained easily findable, and preserve it for future readability. To address this, Neuraly partnered with vendor Arkivum to outsource this archiving need.

Working with Neuraly, Arkivum implemented an archiving and preservation solution tailored to meet all defined requirements. This ensured full compliance with FDA regulations and GCP standards aligned with ALCOA+ principles. The result was a successful, compliant eTMF archive, with Neuraly's team noting that Arkivum was knowledgeable, helpful, and responsive, leading them to plan to use the vendor for subsequent archiving needs.

Neuraly