Clinical Pharmacology

Clinical Pharmacology
Bio people - Gurgaon, Haryana

•Clinical and medical support for the Pharmacokinetic, Pharmacodynamic and Bio-equivalence (BA / BE) studies on company’s generic products. • Monitoring and supervision of the clinical safety parameters (including clinical laboratory investigations) and management of adverse events during the conduct of studies. • Providing medical inputs and information for the preparation of Protocols, Informed Consent Forms and Case Records Forms for clinical studies. • Review of medical screening records (including clinical laboratory investigations) of the prospective subjects so as to ascertain their suitability for inclusion in clinical studies. • Ensuring the accuracy and correctness of clinical raw data, analyzing it and providing inputs for the preparation of clinical reports. • Organization and conduct of bioequivalence studies on company's generic products in accordance with the Institutional Review Board approved study protocol for submission to various International Drug Regulatory Authorities as per prevalent national and international guidelines. • Appropriate delegation & supervision of study-related tasks delegated to Clinical Study Coordinators, Clinical Research Physicians & Nurses, Medical Officers, Pharmacy-in-charges, instrumentation engineer etc. • Ensuring that all personnel delegated study-related tasks are adequately trained in relevant Standard Operating Procedures and national / international guidelines. For more info visit at mentioned link