Biologicals | Consumer Claims | Diagnostic Kits | Drug | Medical Devices | Conducting clinical trial during COVID-19 · CliniexpertsConducting Clinical Trial during COVID-19 COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials. The pandemic also paved the way for new Drug - SNDDrug-FDCDrug-INDDrug-New DrugDrug-Phytopharmaceuticals
Biologicals | Drug | GSR Notification #227: Paving the Way to Clinical Research in India (Part II) · CliniexpertsThe application for permission to conduct clinical research India of a new drug or investigational new drug has to be made in Form CT-04 in place of Form 44. The following are the new provisions to be followed during clinical trials’ conduction in India. Clinical Trials Enrolment Status The clinical trial enrolment status of the CTRIEthics CommitteeFDCNew DrugPhase 4 Trial (PMS)
Biologicals | Drug | GSR Notification #227: Paving the Way to Clinical Research India (Part I) · CliniexpertsThe New Drugs and Clinical Trials Rules, 2019 was declared by the ministry of health and family welfare on 25th March 2019 (GSR Notification #227). The key focus of the new set of rules is to encourage advances in clinical research India. The rules are meant to revolutionize the regulatory aspects for the conduct of CTRIEthics CommitteeFDCNew DrugPhytopharmaceuticals
