Phase I & BA/BE

Clinical Pharmacological Unit

Experience in handling global studies and understanding regulatory requirements works to the advantage of the client, as it ensures timely volunteer enrollment, quality data and efficient study completion. The SOPs and processes are compliant with ICH-GCP guidelines, CFR requirements and all local regulatory requirements.

• 80 bed capacity
• Nursing station with automatic subject raised inbuilt emergency voice alarms and its resolution loops.
• Automated, motorized, ICU beds for BA/BE studies
• On site pharmacy with humidity chamber, laminar air flow and dispensing desk, and separate, controlled pharmacy with separate humidity chamber for Narcotic Drugs and Psychotropic Substances (NDPS)
• Comprehensive and independent screening zone for evaluation of study subjects.
• Online Volunteer Information System (OVIS) to avoid cross participation of volunteers
• Audio - Video recording of written informed consenting process and its uploading on server in case of vulnerable study population, compatible with latest regulatory norms in India
• Access to regulatory compliant Ethics Committee
• In-house CAP certified clinical laboratory
• Dedicated team of professionals including physicians, pharmacists, scientists, project managers, nurses, phlebotomists , dieticians and recruiters
• Need-based availability of medical intensivists, cardiologists and pulmonologists at site
• Tie-up with multi-speciality critical care unit in the vicinity for handling medical emergencies
• Facility inspected and approved by several regulatory agencies.
• Study data submitted to USFDA, MoH (Belarus, Turkey & Israel, Vietnam), EU, ANVISA, DCGI, GCC, MHRA, WHO, MCC, ASEAN, AFFSAPS, TGA, NPRA and Health Canada