Global Drug Development Experts
Global Drug Development (GDD) Experts is the Site Management Organization (SMO) of choice in India. GDD is a US-based company, and brings global expertise in quality assurance and patient enrollment to the Indian SMO market. Unmatched in therapeutic and operational expertise, GDD is committed to our clients’ success. We serve global pharmaceutical, CRO, biotechnology and medical device companies across all clinical trial phases. Our clients demand, and we deliver, world-class results in both Quality and Speed of Enrollment.
Our extensive database of Principal Investigators, leading hospitals, and research centres allows us to access special populations to fulfil your protocol requirements and ensure rapid recruitment of eligible study subjects.
GDD has amassed a level of expertise that enables us to:
- Manage complex global clinical trials across all therapeutic areas, including Neurology, Psychiatry, Oncology, Endocrinology, Cardiology, Infectious Disease, Gastroenterology and Respiratory and other therapeutic areas
- Work with a variety of sponsor compounds
- Ensure our project team professionally executes your program
At GDD Experts, we believe Quality + Speed of Enrolment = Client Success, and understand both elements are important to our clients.
GDD Experts’ SOPs meet the highest standards for conducting clinical trials. We manage our sites with highly qualified personnel experienced in conducting clinical trials while adhering to applicable regulations, guidelines, and ICH Guidelines. This includes ICH E6, schedule Y (Indian Drugs and Cosmetics Act) and U. S. FDA 21 CFR parts 11, 50, 54, 56, 312 & 314. Per schedule Y section 2(3), all GDD sites have implemented and adhere to site SOPs.
To assess your trial’s likelihood of success at our sites, we will perform a Protocol Feasibility Assessment at no cost to you.
- Dr. Munish Mehra