Compliance

Compliance

The world’s first plug-and play GCP-compliant, validated medical monitoring solution

CLICK below to expand individual compliance directives

  • ICH E6 5.3

    Promedim facilitates the ICH E6 5.3 provision that “the sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems. Promedim24 specifically supports the medical monitoring availability requirements of the regulation. We ensure that all of your clinical trials have a full audit history and reporting mechanism to ensure that Physician accountability is fully transparent and that coverage in monitored and mainlined throughout the trial.

  • 21 CFR Part 11

    Promedim has integrated Part 11 compliant Electronic Signatures, records and Audit Trails into our platform. We have created a secure document repository that ensure Physicians always have access t the most current version of the study protocol, and mandates that any changes to the protocol file are captured with a reason for the change as well as an electronic signature.

  • EU Volume 4 Annex 11

    Promedim has fully validated our application to ensure that is complies with Annex 11, including the Infrastructure Qualification Mandate.

  • GCP Data Centre

    Promedim has selected GCP Data Centre provider Sidus Biodata as it's validated infrastructure partner. Promedim24 is hosted within Sidus BioData's fully validated BioCloud and is supported by their Quality Management System. All specific servers supporting Promedim24 have been fully qualified and are under change control. Promedim24 customers may audit Sidus BioData at anytime. For more information visit www.sidusbiodata.com

  • MHRA GMP Data Integrity Definitions and Guidance for Industry

    In anticipation of MHRA's release of their Data Integrity Guidance in January 2015 the Promedim Quality team ensured that our software development artifacts and test cases were fully aligned with MHRA's expectations.