Clinical Pharmacological Units    

Our experience in handling global studies and understanding regulatory requirements works to your advantage as we can ensure timely volunteer enrollment, quality data and efficient study completion. Our SOPs and processes are compliant with ICH-GCP guidelines, CFR requirements and all local regulatory requirements.

Clinical Pharmacological Unit

  • 90 bed capacity
  • 10 fully automated, motorized, ICU beds with centralized oxygen/ suction/ air for Phase I studies
  • Equipped with Pulmonary Function Tests, Nebulizer, Defibrillator, Ventilator, Infusion pump and Ambulatory BP monitor
  • Holter Telemetry System
  • On-site pharmacy and separate, controlled pharmacy for Narcotic Drugs and Psychotropic Substances (NDPS)
  • Continuous cardiac monitor and pharmacodynamic center
  • Mortara certified cardiac safety lab ideal for TQTc studies
  • Central Data Recording/ Retrieving system
  • Separate area for screening
  • OVIS (Online Volunteer Information System) to avoid cross participation of volunteers
  • Audio - Video recording of informed consent process, compatible with latest regulatory norms in India
  • Access to Regulatory compliant Ethics Committee
  • In-house CLIA & CAP certified clinical laboratory
  • In-house GLP-certified bioanalytical laboratory
  • Dedicated team of professionals including physicians, pharmacists, scientists, project managers, nurses, phlebotomists and recruiters
  • Need-based availability of medical intensivists, cardiologists and pulmonologists at site
  • Tie-up with critical care unit in the vicinity for handling medical emergencies
  • Facility inspected and approved by several regulatory agencies
  • Study data submitted to USFDA, MoH (Turkey & Israel), EU, ANVISA, DCGI, MHRA, WHO, MCC, ASEAN, AFFSAPS, TGA, and Health Canada