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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Wiener, Chet, PhD
Business Name Chet Wiener PhD: Medical Writing, Editing, Translation
Certifications
Education

1998                PhD, Columbia University, New York, New York

1992-93           École Normale Supérieure, Élève d’échange (Research), Paris

1989                MFA (Iowa Writers’ Workshop), University of Iowa, Iowa City, Iowa

1985                MA, University of Chicago, Chicago, Illinois

1983                BA, The Johns Hopkins University, Baltimore, Maryland

Business Address 945 Taraval Street, ste. 295
San Francisco, CA 94116
Contact information
Telephone:
Mobile Number:
Email address:
+1.415.839.6371
1.415.518.5248
chetwiener@chetwiener.com
Specialties

Writing and Editing

     ¶ Clinical Study Reports

     ¶ Protocols

     ¶ Clinical Safety Summaries

     ¶ Investigator's Brochures

     ¶ Preclinical manuscripts, journal articles, briefing documents, procedural manuals and brochures.

Knowledge of  ICH guidelines and FDA, EMEA and Health Canada regulations

Pharmacokinetic and Pharmacodynamic reporting including population PK

Device Clinical Evaluation Reporting

Regulatory and Clinical History Compilation and Research

Risk-Benefit Analysis

Experience

Clients have included: Actelion Pharmaceuticals Ltd; BioMarin Pharmaceutical Inc; Cambridge Group; Cerexa, Inc.; Generex Corp; i3 Pharma; Geron Corporation; Institute for One World Health; InterMune, Inc.; MannKind Corp.; Marion Weinreb and Associates, Inc.; Medtronic Xomed, Inc.; Questcor, Inc.; Osmos Clinical Research, Inc., XDx, Inc.

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