Long term archiving of clinical trials records

[Petra Zrustova]

Hi all,

I work for an NGO that is conducting clinical trials. As the trial sponsor, we are responsible for archiving the electronic Trial Master File (eTMF). Since we operate with a limited budget, I am currently looking for a cost-effective archiving solution.

Does anyone have experience using AtoM for long-term archiving of clinical trial data? We need to ensure archiving for 25 years while remaining inspection-ready and compliant with ICH-GCP and CTR.

Many thanks in advance for your insights!

Kind regards,

Petra