Evidence compliance with the EU CTR +25 year retention requirement
Actively maintain the TMF and essential trial records so that they are accessible, available and readable for over 25 years.
Standard IT storage, ‘locked’ systems and backups are no longer fit for purpose
With the EU extending the clock on essential trial records retention periods to 25 years or longer; standard IT storage, archived/locked systems and backups are no longer fit for purpose.
- Digital assets often outline the software used to create them causing obsolete formats to be unreadable on future devices
- Data left in proprietary, legacy or obsolete systems risks hardware failure or lock-in, resulting in permanently inaccessible records
- Satisfying the ‘Enduring’ principle of ALCOA+ requires sponsors to evidence integrity hasn’t failed and be able to ‘heal’ corrupted records
- Slow to retrieve records are incompatible with today’s inspectors, who demand they are readily accessible and available on request
eBook: Guide to preserving the eTMF for +25 years
Guidance on what you need to get started archiving the eTMF in line with regulations (e.g. EU CTR), ICH E6(R3) and ALCOA+. Provides practical considerations and approaches for anyone responsible for managing (or involved in) the retention the TMF and clinical records.
Complete the form below to access the guide.
Compliant retention with automated digital preservation
Maintaining digital trials records and data for +25 years is challenging.
We provide the only GxP validated digital archiving and preservation solution, built for the pharmaceutical industry.
It requires ongoing efforts throughout the lifecycle of the data. An automated digital preservation solution can support a sponsor’s retention strategy, ensuring records are accessible, available and legible throughout the retention period. Just some of the features of a digital preservation solution include:
Preservation
Generate and maintain long term preservation copies of every record
Safeguarding
Periodic data integrity checks to quickly identify any changes or damage to records
Inspection Readiness
Provide direct inspector access to trial records during an inspection
Retention Management
Retention rules applied by study and region
Pharma & life sciences organisations working with Arkivum
Trusted by sponsors across Europe and the US, Arkivum proactively maintains data in long-term usable formats, automatically safeguard against corruption and enable the consolidation of archived records & data.
Speak to our team
Want to arrange some time with our team about how we can help with your eTMF retention requirements?
Please use this form or the contact details below to register your interest and a member of our team will be in touch as soon as possible.
Quadrant House, 20 Broad Street Mall
Reading, RG1 7QE