Clinical Trials and Regulatory Affairs in Drug Development
Clinical trials are essential for evaluating the safety, efficacy, and pharmacological profile of new therapeutics. Rigorous design, ethical conduct, and regulatory compliance ensure data integrity and patient safety. This area encompasses phase I–IV trials, adaptive trial designs, and post-marketing surveillance. Regulatory frameworks, including FDA, EMA, and ICH guidelines, govern trial protocols, documentation, and approval pathways. Integration of real-world data, biomarkers, and patient stratification improves trial outcomes and accelerates approval timelines. Efficient regulatory navigation supports successful translation of discoveries into market-ready therapeutics.
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