Prasad NV Tata
Director of Clinical Pharmacology and Biopharmaceutics, PAR Pharmaceuticals
Providing overall scientific and operational clinical development leadership for the pharmaceutical products developed by PAR Pharmaceutical group of companies in three locations. These responsibilities include planning, budgeting, execution and due diligence activities. Performed, sourcing, site qualification, study conduct and performance monitoring of the North American and international CROs and consultants. Prepared, and defended clinical development plans, IDBs, section summaries in INDs, NDAs and ANDAs. Managed CROs, consultants, opinion leaders for their Clinical Pharmacology and Clinical Regulatory input in fulfilling requirements for many quick turnaround projects. Implemented procedures in harmonizing procedures and report requirements. When needed served as a company’s clinical operational expert in study monitoring and closeout activities.