Medical Monitoring for clinical trials in Asia, China, and Japan. Medical monitor Asia, China, and Japan, medical monitors and medical monitoring service for China, Japan an Asia Clinical Trails. Doug Berger, M.D., Ph.D. & Associates



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Medical Monitoring in China, Japan, and Asia. Medical Monitors and Medical Monitoring Service for China, Japan and Asia Clinical Trails.

Doug Berger, M.D., Ph.D. and Associates, Clinical Development and Pharmaceutical Consultants: Medical Monitor Service for China, Japan, and Asia.

Pharmaceutical Consulting Page

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Dr. Douglas Berger and his medical physician staff of medical monitors have extensive experience in clinical trials and medical monitoring in China, Japan, and pan-Asia clinical trials for any therapeutic area. Knowledge of GCP, experience in subject entry eligibility, understanding and effecting clinical-trial protocols properly, and insuring safety reporting are GCP compliant and make medical sense are the key areas of medical monitoring provided. Dr. Berger and his staff place a high value on clear and precise medical support for clinical trials along the lines required by each sponsor. The physician staff can provide medical monitoring in English, Japanese, and Chinese, and are native and/or fully fluent in these languages, and have received medical licenses in China, Japan, and the United States.

    Medical Monitoring Service Summary:

  • Medical monitor task lists for each trial are created.
  • Q&A logs from the investigators and sites are made.
  • Regular internal meetings ensure a high-quality of medical monitoring.
  • Forms for entry eligibility for the sites, medical monitoring assessment of eligibility and safety, hospitalization tracking, and other forms are created by the medical monitor to help the quality of the trial.
  • All contacts between the sponsor or sites and the medical monitor are made ready to file in the sponsor's TMF.

Dr. Berger has many years of pharmaceutical experience in Japan in positions including Director of Clinical Development and Project Manager for Clinical Development, and has served for a number of years on the R&D Portfolio Review Board of a for a multinational pharmaceutical corporation's Japan office. He is currently Medical Director Asia-Pacific Region, for a Global Pharmaceutical Research Company, focusing on medical monitoring, and he is Director of the Tokyo Meguro Counseling Center. Detailed corporate experience can be provided on request.

Selected Pharmaceutical Papers By Dr. Berger

Papers in English and/or Japanese can be read by clicking on the highlighted paper title. The journals' home pages can be accessed by clicking on the highlighted journal names.

  1. Berger D, Ruano P, Eames, D: PMDA CONSULTATION FOR CLINICAL DRUG DEVELOPMENT IN JAPAN, Pharma Japan, 2186; 14-15. April 26, 2010.

  2. Berger D, Ruano P, Eames, D: HOW NOT TO LICENSE A DRUG INTO JAPAN, Pharma Japan, 2159; 16-17. October 12, 2009.

  3. Berger D: PHARMACEUTICAL PARTNERSHIPS IN JAPAN FOR REGULATORY AND COMMERCIAL SUCCESS, Pharma Japan, 2096; 16-17. June 30, 2008.

  4. Berger D: METHODOLOGIC ISSUES IN THE CLINICAL TRIAL STUDY OF DEPRESSION, Pharma Japan, 2083; 18-19. March 24, 2008.

  5. Berger D: ANTIDEPRESSANT DRUG DEVELOPENT IN JAPAN: CURRENT PERSPECTIVES AND FUTURE HORIZONS, Clinical Research Focus, 16:7, 32-35, Sept 2005.

  6. Berger D, Fukunishi I: PSYCHIATRIC DRUG DEVELOPMENT IN JAPAN, Science, 273 (July 19), 318-319;1996.

  7. Berger D, Nezu S, Iga T, Hosaka T, Nakamura S: INFORMATION PROCESSING EFFECT ON SACCADIC REACTION TIME IN SCHIZOPHRENIA, Neuropsychiatry, Neuropsychology & Behavioral Neurology, 3:2, 80-97;1990.

Contact Information

phone Telephone : 03-3716-6624 (from within Japan) or +81-3-3716-6624 (from outside of Japan). Although you will almost always get the answering machine, most calls are returned within a few hours. Also, please note that as your call may be forwarded to a mobile phone, you may need to wait a few seconds for transfer, and because of this there is no fax function.

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