 |
|||||||
|
 |
|||||
|
|
|
|
|
|
|
Michael Thorn, Dr. P.H. |
|||||
|
Services Offered: Biostatistics and creation of statistical analysis plans, strategic design of clinical development plans, data management, design of clinical trials, biostatistical contributions to NDAs, CTDs and other regulatory documents. Pharmaceutical and Biotechnology Experience: Dr. Michael D. Thorn provides over 20 years of experience in statistics, involving pharmaceutical, biologic and medical device research, in all aspects of biopharmaceutical development. Dr. Thorn served as Director of Biometrics for a major CRO before leaving to create his own company, Statistical Resources, Inc., in 1996. Over the course of his career, he has been involved in all aspects of development of pharmaceutical, biologic, and medical devices, from the founding of new companies, the strategic design of clinical developmental plans, the design of clinical trials, meetings with regulatory agencies (US and Canada), including Pre-IND and IDE, end of phase II, Pre-NDA, Pre-PMA, and presentations for FDA Advisory Panel meetings. Dr. Thorn has been completely involved in the programming, review, and statistical write-ups of statistical analysis plans, clinical trial reports, NDA/CTD submissions, and other regulatory documents. He has been involved in statistical analyses for publications in the biomedical literature, including extensive experience in cardiology trials. Dr. Thorn has also been involved in the planning and/or administration of at least 25 Data and Safety Monitoring Boards (DSMBs). Dr. Thorn is the President of Statistical Resources, Inc. (www.statisticalresources.com) |
|||||
|
The BioPharm Team |
|||||