Case Study: Phlexglobal achieves secure, compliant eTMF archiving with Arkivum TRUST

Phlexglobal - Customer Case Study

Phlexglobal, a specialist provider of TMF and eTMF document management solutions, needed a secure, regulatory compliant way to archive electronic clinical trial records and associated metadata for long-term retention. Working with Arkivum, the company sought to reduce eTMF maintenance costs while meeting strict archiving requirements and preserving millions of pages across a growing number of clinical trials.

Arkivum implemented Arkivum TRUST with Phlexglobal’s PhlexEarchive and PhlexEview to automatically transform records into PDF/A and XML, store them nearline or offline, and make them available for retrieval within 24 hours on weekdays. The solution supports 25-year retention, meets 21 CFR Part 11 requirements, and provides an insurance-backed 100% data integrity guarantee; the pharmaceutical customer has already archived 200 clinical trials and is planning to process around 5 million pages from more than 200 trials.

Phlexglobal