Neuraly Case Study: Helping a revolutionary clinical-stage biotechnology company become GCP compliant
You can access the full Neuraly case study here.
With two clinical studies in Phase II and three more in pre-clinical stages, Neuraly – a clinical-stage biotechnology company – sought to outsource the archival of the electronic trial master file (eTMF) to ensure that they were compliant with the requirements that have been set out by Good Clinical Practice (GCP).
Some of the challenges Neuraly faced were:
- Safeguarding the data to ensure that it is not lost or corrupted.
- Archiving the data in such a way that it could be easily found if required.
- Preserving the data so that the information could be read and used.
As part of the implementation and integration of the archiving and preservation solution, Neuraly and Arkivum identified and defined all of their requirements ensuring they were fully compliant with FDA regulations, GCP standards and in alignment with ALCOA+ principles.
If you’re interested in reading more about Neuraly’s digital preservation journey and how they became compliant with these regulations, please click here.
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