Medical Devices | Best Practices for Designing Medical Device Clinical InvestigationsBest Practices for Designing Medical Device Clinical Investigations What is a clinical investigation of medical devices? Devices, much like pharmaceuticals, must go through extensive testing processes before gaining approval for use on patients. However, Medical Device Clinical Investigations tend to be more manageable and involve fewer stages compared to pharmaceutical trials. Clinical investigation concerning medical Clinical Investigation of a Device
Biologicals | Diagnostic Kits | Drug | Medical Devices | The Drug Development Process – From Conception to Market · CliniexpertsThe Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug Phase 1 TrialPhase 2 TrialPhase 3 TrialPhase 4 Trial (PMS)Drug - SND
Biologicals | Consumer Claims | Diagnostic Kits | Drug | Medical Devices | Effective Site Management in Clinical Research – Points to Consider · CliniexpertsEffective Site Management in Clinical Research – Points to Consider Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites. Site management in clinical research Efficient site management is essential to ensure that the clinical Global Clinical TrialLocal Clinical TrialSite ManagementSite Management
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 | Diagnostic Kits | Drug | Medical Devices | Online submission of SAE reports through SUGAM portal · CliniexpertsOnline submission of SAE reports through SUGAM portal The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of BiologicalsDiagnostic KitsDrugMedical DevicesPhase 4 Trial (PMS)
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 | Medical Devices | Periodic Safety Update Report (PSUR Consideration) · CliniexpertsPeriodic safety update reports (PSUR Consideration) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised Phase 4 Trial (PMS)