Case Study: Aspire Pharma achieves 25-year compliant TMF archiving with Arkivum

Aspire Pharma Limited secures 25+ years of TMF retention with Arkivum

Aspire Pharma Limited, a UK-based pharmaceutical company, needed a compliant solution to archive its clinical trial data for a minimum of 25 years to meet new EU Regulation 536/2014 requirements. Their previous method of storing data on a secure server was not suitable for long-term preservation, accessibility, or auditability. They required a cost-effective, GAMP5-validated system that would ensure data integrity without being overly burdensome. They selected Arkivum for its digital archiving and preservation service.

Arkivum provided a solution that ensured the long-term integrity and accessibility of Aspire Pharma's data, including a well-managed migration process and extensive support. The result was a compliant archive where records are easily searchable for inspections with minimal ongoing effort required from Aspire staff. Arkivum's service met the company's budget requirements and will allow them to independently manage future data migrations using templates.

Aspire Pharma Limited