One of the first questions we get asked as an eClinical systems provider is ‘Is your system FDA compliant?’. The short answer is yes. Our system was built from scratch using the CDISC ODM model in order to facilitate a structure that allows studies to be designed with a full audit trail to meet the requirements that FDA21 part 11 requires. You can read a little more about that here (link to security and compliance page). We also produce and follow a number of clearly identified policies and procedures as part of the compliance procedures. The system also meets GCP (Good Clinical Practice) guidelines.
isn’t always understood is that compliance from the system
provider’s perspective is self certifying. I.e. the FDA does not
issue certificates of compliance. So, how does the provider
demonstrate or prove compliance? There is only one practical way to
do this, and that is to use an independent, specialist auditor. So
that’s what we do with CRFweb and our audit is available for you to
see on request.
of course, a compliant system does automatically equate to a
compliant trial. Responsibility for compliance will always remain the
responsibility of the person with overall responsibility for data
management. The study database is the secure vault built on the
foundations of compliant methodology, study design, subject selection
and data collection.
is a whole lot more than ticking a compliance box; the time and cost
savings from using our eCRF and ePRO functionality are, we believe,
readily apparent. But knowing that this fundamental part of the whole
trial process is built, designed, delivered and hosted to the
standards required offers more than just peace of mind, it’s
critical to the compliance of the whole study.