As the Medical Device Regulation (MDR) deadlines are approaching for re-certification and/or introduction of new products, manufacturers are also working to start or fulfil the Post-market Clinical Follow-up (PMCF) activities as per requirements set out in Annex XIV, part B of the MDR. The Annex states “PMCF shall be understood to be a continuous process…
Good Clinical Research Practice (GCP) is an established international ethical and scientific quality standard process for the design, conduct, performance, auditing, monitoring, recording, analysis, and reporting of clinical studies. GCP ensures that the reported data and results are credible and accurate, and the rights integrity and confidentiality of study subjects are respected and protected. All…
Effective from March 19, 2019, The New Drug and Clinical Trial Rules released by the Ministry of Health and Family Welfare have met with mixed reviews by the industry. These rules which apply to Investigational new drugs for humans, clinical trials, bioequivalence and bioavailability studies, except the chapter on ethics, were much awaited by the…
In the clinical trials industry, 80% of trials do not meet enrolment timelines, leading to a loss of $8 million per day. Delayed enrolment not only impacts trial timelines, but more trials are being cancelled because of it, preventing investigators from determining the safety and efficacy of what could be promising new therapies for patients…
