Bradstreet Clinical Research

Bradstreet Executive Leadership

Bradstreet Clinical Research Inc. has been a clinical and regulatory consulting company for almost two decades. It is composed of medical, clinical and regulatory professionals who worked together in the pharmaceutical industry for many years prior to forming this company so our professional history is very long.

Patricia Bradstreet
President and CEO
Patricia Bradstreet, the founder, President and CEO of BRADSTREET, is a microbiologist with over 30 years of experience in clinical research, project management and regulatory submissions. Her particular strengths include project management and the ability to assemble the right team for each assignment. Particular areas of experience include contact lenses, cystic fibrosis, dental studies, hepatitis, infectious diseases, monoclonal antibodies, oncology, osteoarthritis, pain management, wound healing, women's health care and sexually transmitted diseases.
Stanley G. Schutzbank, Ph.D., RAC
Executive Vice President
Dr. Schutzbank, the Executive Vice President of BRADSTREET, has over 30 years of experience in clinical research, regulatory affairs, project management and executive management. He served as chairman of the Regulatory Affairs Professional Society (RAPS) and the Regulatory Affairs Certification Board and has extensive experience in the preparation and submission of INDs, BLAs and PMAs.
Peter Levitch
Regulatory Strategist/Consultant.
Extensive, Effective Industry Experience. Pharmaceuticals, Biologicals, Medical Devices. Formerly Director of Clinical and Regulatory Affairs at J&J Company, Responsible Head to CBER, Official Correspondent to CDRH. Participated in the FDA Approval of Several Biotechnology Derived Products.
Specializes in Development of Strategic Regulatory Plans, Providing Clear Pathway to FDA Product Approval.
CV and References Available upon Request.
Bridgewater, NJ. 908-526-9162/908-892-0300

Bradstreet Key Staff inclules:

MD oncologist with 25 years of pharmaceutical clinical research experience

PhD level writers who handle both clinical and regulatory writing

PhD epidemiologist/statistician

PhD level CMC/GMP experts

VP of Clinical Operations, who leads our Clinical Quality Assurance Group

PhD level regulatory affairs professionals with 25 years of experience

Network of 20 local and regional clinical study monitors

Project managers

Information Technology/Part 11 compliance manager

Clinical Administrators

Data management services

PhD primary statistician

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Bradstreet Executive Leadership Bradstreet Clinical Research Inc. has been a clinical and regulatory consulting company for almost two decades. It is composed of medical, clinical and regulatory professionals who worked together in the pharmaceutical industry for many years prior to forming this company so our professional history is very long. Patricia Bradstreet President and CEO Patricia Bradstreet, the founder, President and CEO of BRADSTREET, is a microbiologist with over 30 years of experience in clinical research, project management and regulatory submissions. Her particular strengths include project management and the ability to assemble the right team for each assignment. Particular areas of experience include contact lenses, cystic fibrosis, dental studies, hepatitis, infectious diseases, monoclonal antibodies, oncology, osteoarthritis, pain management, wound healing, women's health care and sexually transmitted diseases. Stanley G. Schutzbank, Ph.D., RAC Executive Vice President Dr. Schutzbank, the Executive Vice President of BRADSTREET, has over 30 years of experience in clinical research, regulatory affairs, project management and executive management. He served as chairman of the Regulatory Affairs Professional Society (RAPS) and the Regulatory Affairs Certification Board and has extensive experience in the preparation and submission of INDs, BLAs and PMAs. Peter Levitch Regulatory Strategist/Consultant. Extensive, Effective Industry Experience. Pharmaceuticals, Biologicals, Medical Devices. Formerly Director of Clinical and Regulatory Affairs at J&J Company, Responsible Head to CBER, Official Correspondent to CDRH. Participated in the FDA Approval of Several Biotechnology Derived Products. Specializes in Development of Strategic Regulatory Plans, Providing Clear Pathway to FDA Product Approval. CV and References Available upon Request. Bridgewater, NJ. 908-526-9162/908-892-0300 Bradstreet Key Staff inclules: MD oncologist with 25 years of pharmaceutical clinical research experience PhD level writers who handle both clinical and regulatory writing PhD epidemiologist/statistician PhD level CMC/GMP experts VP of Clinical Operations, who leads our Clinical Quality Assurance Group PhD level regulatory affairs professionals with 25 years of experience Network of 20 local and regional clinical study monitors Project managers Information Technology/Part 11 compliance manager Clinical Administrators Data management services PhD primary statistician top