What are Clinical Trials?
Clinical trials also called as clinical research designed to evaluate safety and efficacy of promising therapeutic products having potential to reach market. Abiogenesis Clinpharm helps in conducting trials with ideal design considered optimum for a therapeutic product. As a best clinical research organisation in India, the team is well versed with appropriate recruitment strategies, quality procedures and essential data handling. We provide services in regulatory, medical writing and medical monitoring for clinical trials along with statistical analysis, clinical data management and post-marketing surveillance studies to the clients.Concerns on meeting sponsor timelines are exclusively addressed to get timely recruitment and putting operational methods in place which makes conduct of the trial easier. Abiogenesis Clinpharm Private Limited would be the best partner for pharmaceutical, Nutraceutical and Medical Device Companies worldwide to carry the development of their promising and potential therapeutic products.
Phases of Clinical Trials
Phase I studies: New investigational product tested in smaller groups of healthy volunteers (SAD: Single Ascending Dose or MAD: Multiple Ascending Dose).
Phase II studies: Product is investigated in smaller number of patients to explore ideal dose with better efficacy & safety.
Phase III studies: Investigational product is tested in large number of patients from multiple centers to confirm the suitable dose for marketing approval.
Phase IV studies: Following a product approval, post-marketing trials are conducted to monitor safety and efficacy for long-term risks and benefits including detection of rare or very rare side effects.