By Mika Nuutilainen, Director, Product Development, CRF Health
In the last blog article I discussed the definition of cloud and its advertised benefits. In regard to clinical trials data, the biggest problem with cloud services is that there is no easy way to ensure that data really will stay unaffected when stored in the cloud service. How could I be assured that no other application, person, or service will change my ePRO data? And how could I guarantee the FDA the same.
Major cloud computing service providers do have security certificates, but it is still uncertain for a customer how well the data is really taken care of. Cloud service providers have developed their processes to provide service within minutes and completely automatically. So IQ, OQ, and PQ (system validation steps) with objective evidence could be hard cases to provide for in all server installations. When your servers are provisioned and deployed as virtual machines in the cloud, validation of your installation in the way we are used to is not possible anymore.