MHRA completed consultation on real-world evidence
22 March 2022
- Guidance issued for Sponsors planning to conduct clinical research to support regulatory decisions
- Use of RWE has the potential for increasing the speed and reducing the cost of development programmes, which would see effective medications being approved more quickly
- The MHRA encourages Sponsors to explore the opportunities presented by the utilisation of RWE
- RWE just as valuable for regulatory decision making as evidence from conventional RCTs, provided the data quality is robust and the trial well designed
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About SVMPharma
SVMPharma is an innovative strategic consultancy and CRO, with a focus in Real World Evidence (RWE) for pharmaceutical and biotechnology companies. SVMPharma delivers clinical trials within UK and Europe.
About DISTILL
DISTILL is a new EDC launched by SVMPharma. As a CRO discover the benefits of DISTILL as part of your service offering and take back control of your clinical trials. DISTILL allows you to develop and manage every aspect of your trials from start to finish. Move away from the restrictions and costs associated with legacy systems.
For more information, please visit www.svmpharma.com and contact us at enquiry@svmpharma.com
Ref: RWEMAR2022BSA