Revision R3 of the ICH guideline for good clinical practice (GCP) represents an important shift away from traditional models towards more flexible, risk-based approaches with emphasis on Quality by Design and Risk Proportionality. The integration of innovative trial designs and technologies sets up a new framework for conducting clinical research while maintaining a high level of ethics, data integrity, and patient safety. This requires thorough preparation and revision of current practices and processes throughout the lifecycle of clinical trials.
Evnia has in place a comprehensive consultation program dedicated to accommodate the increased regulatory needs coming out of ICH GCP E6 R(3).
Our mission is to debunk the misconception that regulatory compliance hurdles clinical research.
We enable manufacturers to identify and address regulatory requirements to achieve agility, resilience and to build a sustainable clinical trials ecosystem.
Evnia supports organisations in the design, conduct, monitoring and reporting of clinical activities and supports the lifecycle management of medicines and medical devices.
Evnia offers
- A streamlined, one-stop solution for your clinical research needs
- In-house, multidisciplinary expertise
- Standardised processes and customisable templates
- A pan-European clinical network with access to diverse populations and the ability to collect both prospective and retrospective clinical data
Contact us for an introductory discussion!
Download the document: FET ICH GCP E6(R3) – White Paper
or watch the video below:
