eTMF solutions

eTMF

We help pharmaceutical and biotech companies to better manage clinical trial by providing modern cloud based electronic Trial master file (eTMF) solutions. This provided sponsors ongoing and instant access to trial documentation at every point in a trial’s set-up, execution and archival.

Our electronic solutions provides documents in submission ready format. Our comprehensive reports helps you track the accurate statuses of informed consents, CVs, Ethics committee approvals, electronic case report forms, financial disclosures  many more, which results in better productivity and compliance from study start to submission/archival. Here are some of the features of the eTMF systems you will have automatic access with us:

  • Integrated Digital Signing: Lower document completion costs and ensure document quality and integrity with integrated FDA compliant digital signing with the eTMF system. Includes automated signer validation and an exportable FDA compliant audit trail.
  • CRAs, Investigators and others can sign clinical trial documents from within the application, enhancing compliance, auditability and document integrity.
  •  eTMF content classification templates that are based on standards-based metadata from NCI, BRIDG and HL7.
  •  Cloud eTMF provider to offer integrated FDA and EU compliant digital Esignature support via Adobe® Digital ID certificate signing.
  • Compliance with 21 CFR Part 11 requirements for electronic/digital signatures
  •  Reporting function allows printing of all records, documents and reports in hard copy or electronic format.
  •  Global certified cloud & 24/7 support
  • Archiving allows any part or the entire eTMF repository to be securely exported to DVD or other media for independent offline review by independent auditors, quality consultants or non-users. Archives may be stored encrypted, or for long term archiving, stored unencrypted on DVD securely