Omkar Kulkarni

CLINNEX is a CRO providing Clinical Operations, Biometrics (clinical data management, statistical analysis, and medical writing) , Pharmacovigilance, eTMF services to pharmaceutical, bio-tech, and medical device companies. CLINNEX strives to be a quality focused company, understanding the client requirements and the unique challenges in performing various types of clinical trials. Apart from extensive experience in robust Project Management which bonds all the Biometrics services, Clinnex also brings to the table experience in providing Biometrics support in various European languages through our tie up with our European counterpart. Our experience and understanding of Paper as well as Electronic Data Capture (EDC) processes and systems enables to provide the optimum solution for each project. Our experience covers all phases and design of clinical research, spanning across various therapeutic areas, and delivering high quality output. At the same time, our services are tailored to fit the various clinical trial needs of our clients, starting from individual stand-alone services to execution of end to end services as per the agreed standards. Our Biometrics services include: - Clinical Data Management (EDC / Paper) - Statistical Analysis - Medical Writing services. All our services and systems are governed by well defined SOPs and are compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11, CDISC and other customer specific standards.