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
Medical Devices | Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India · CliniexpertsCurrent Regulatory Scenario for Conducting Medical Device Clinical Trials in India Medical devices complement the physician’s or surgeon’s expertise in examination, diagnosis, treatment, or follow-up. Access to medical devices helps a physician come up with the right diagnosis of the patient’s medical condition, or a surgeon to carry out a procedure accurately. These devices enjoy Clinical Investigation of a DeviceClinical performance evaluationClinical Study ReportCTRIData Management
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
Biologicals | Human Vaccines – Vaccines Developmental Paradigm India · CliniexpertsVaccines are one of the most beneficial and valuable disease prevention measures contributing to long-term health gains. Advancements in research have led to the development of novel vaccines and delivery technologies and this is has caused a paradigm shift in the way diseases are prevented and treated. Even though the field of vaccines have evolved Blood productsCTRIEthics CommitteePhase 1 TrialPhase 2 Trial