Recent changes in regulatory and clinical research activity in India initiated in 2011-2012, have resulted in a stronger, robust and streamlined clinical trial process today. From 2013-2014, Regulatory authorities in Delhi strengthened study approval processes, and rewrote policies on how clinical trials are conducted. Many, if not all of the issues impacting both biopharmaceutical sponsors and CRO clinical research services India, are largely mitigated or completely removed, resulting in more streamlined, scheduled, and timely process, in clinical trial activity 2016 and beyond.
India is a preferred destination for global biopharmaceuticals to conduct it’s clinical trial activity, as:
- Recent Delhi based regulatory reforms focused on and strengthened: consistency, accountability, transparency and predictability.
- Sizable and growing Indian pharmaceutical market – Access for market registration, post clinical trial activity, to 17% of world’s population.
- Vast and diverse patient pool. The vast majority (64%) of Indian population is between 15-64 years of age; the demographic base in interaction with clinical research organizations (CRO) in India.
- State of art facilities, infrastructure and efficient resources with relevant expertise.
- Cost efficiencies and economies of scale given wide array of infrastructure, research institutions and depth, quantity of ICH-GCP trained medical expertise.
Recent changes in the India based regulatory environment is infusing confidence among all stakeholders who are interested to invest in drug development & commercialization of their innovative drugs and new products in India. Excel Life Sciences is your clinical research organization in India. With Strong regulatory expertise – including 100% success rate in regulatory approvals, ELS maintains strong regulatory and operations teams along with a large network of qualified investigative sites with experienced investigators as the top CRO in India, across in-country clinical research organizations.