Vadim ***** , MD has formal training as a Board Certified Internist with clinical practice and research experience in Russia and the US. Dr. ***** has over 15 years of clinical research experience including all aspects of project management as well as audit and monitoring clinical trials, investigator/patient recruitment, protocol and CRF development, SOP writing, and development of study specific educational materials.

Dr. ***** has had considerable research interests in multiple therapeutic areas including oncology, infectious diseases, autoimmune disorders, psychiatry and neurology among others. In November 1992 Dr. ***** founded Placet Research that currently offers consulting services to pharmaceutical, biotechnology, and medical device companies domestically and internationally in the capacity of audit, project management and monitoring. He has very extensive experience working with different types of organizations such as academic institutions (Stanford University), sponsor companies (Merck, Genentech, J&J, BMS, Daiichi, PDL, Telik, Ilypsa, Relypsa, etc) and CROs (ICON, PPD, CSMG, i3Statprobe, Covance, Kendle, Quintiles, MDS, Parexel, etc).

Dr. ***** is a frequent guest speaker at conferences and seminars as well as a consultant to Guidepoint Global Advisors, an exclusive community of academic and industry professionals who provide consulting services to the financial industry. In 2004 he was one of co-founders of BIORAMA (Biological Russian-American Association) and he was a guest speaker at the Optimizing Patient Enrollment in Clinical Trials Forum (International vs. USA-based CRO's) and MAGI's conferences.

Specialties

- Development and management of clinical trials (pharm/biotech/medical device industries);
- Site/CRO/vendor AUDIT in US, Western and Eastern Europe;
- Development and maintenance of study protocols and plans, CRF, SOP, etc. ;
- Knowledge of GCP/ICH and FDA regulations, clinical and medical research methodology and terminology (MedDRA, WHODRL);
- Set-up of investigating meetings, presentations;
- PROFESSIONAL TRAINING & COACHING