Dr. Vinod Tiwari

Role involved: Pre Audit / Inspection review of TMF documentation, identifying missing documentation / compiling tracking sheets in accordance with Phlexglobal Ltd or the client company SOPs. Performing first and 2nd QCs of essential study documentations along with set up and maintenance of electronic filing templates. Participating weekly and monthly meetings and provide them the progress reports.

Maintaining effective communication, filing the business reports, Counseling prospects for trial participation, Client presentations for developing knowledge partners, guest lectures/ training to health professionals, assured compliance with CFR guidelines, participated in on-site audits, site management, timely reporting of AEs/Protocol Violations, Drug Accountability, SDF verification according to contractual requirements, prepared site visit reports and assisted with study start up materials

Preclinical studies, Ethics & Regulations of Clinical Research, Statistical analysis, Business management & Health Economics, Patents & IPR, ICH-GCP, Quality Assurance, Pre-clinical & Clinical research designs, Drug Development Process, Pharmacovigilance, Trial Design, Statistics & Outsourcing.

Marketing Management, Finance Management, Operation Management, Contract Management, Human Resource Management, Business Economics, Customer relation Management, Supply Chain Management.

Ayurvedic Medicine, Surgery, Pharmacology, Gynaecology, Forensic Science and Toxicology, Paediatrics, ENT, Ophthalmology, Pathology, Physiology & Anatomy.