e-CRF

 

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

GB Pharma designs, provides and validates its eCRF. Although technologically advanced, it is simple and immediate to use and able to guarantee security and flexibility in the management of Clinical Trials, Observational and Epidemiological Studies.

Specific features for interventional trials:

  • Secure transmission of sensitive data: use of HTTPS SSL3 protocol
  • Audit trail
  • FDA 21 CFR part. 11 compliant
  • GAMP 5 validation SOP’s and documentation

For NIS/Outcome Research studies, eCRF designed according to sponsor’s request

Cloud Imaging

  • Cloud storage management of images (e.g. RMN, TC scan , etc .. ) via validated devices; data received from sites are encrypted and anonymized before the upload
  • Interaction with GB Pharma eCRF

> Our e-CRF works with Apple iOS, Android and other mobile devices

> Possibility of interaction with vendors