by Turacoz | Apr 23, 2024 | Clinical study, Clinical Trials
In clinical research, documenting results and findings is as important as conducting the study. The Clinical Study Report (CSR) is crucial in this process. It is essential to evaluate the safety and effectiveness of new drugs and therapies, whether you are a...
by Sanvritti Manjreka | Aug 25, 2020 | Clinical Trials
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,...
by Mansi Mishra | Apr 24, 2020 | Clinical Trials
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...
by Tanya Kapur | Apr 15, 2019 | Clinical Trials
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...
by Anjaly Maria Jose | Mar 11, 2019 | Clinical Trials
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...