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 | 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 FDCSNDDrug - SNDDrug-FDCDrug-IND
Drug | Real-World Evidence in India: An Untapped Opportunity for Global Pharmaceutical CompaniesIntroduction The Pharmaceutical industry has long recognised that randomised controlled trials (RCTs), while the gold standard for establishing efficacy, cannot fully capture how Drugs perform across diverse patient populations in routine clinical practice. Real-world evidence (RWE) — data generated outside traditional randomised controlled trials, including electronic health records, claims databases, disease registries, and prospective observational Phase 4 Trial (PMS)Drug-New DrugBiostatistics
Clinical Trials | Five Regulatory Mistakes in Clinical Trials in India — And How to Avoid ThemIntroduction A well-designed clinical trial can be significantly delayed — sometimes by six months or more — before a single patient is enrolled, if the Clinical Trial Application submitted to CDSCO is incomplete, inconsistent, or non-compliant. In India’s regulatory environment, where CDSCO is applying increasingly rigorous review standards under the NDCT Rules 2019, the quality Phase 1 TrialPhase 2 TrialPhase 3 TrialDrug-INDDrug-New Drug