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Flower Valley Consulting, Inc provides statistical advice and guidance
to the pharmaceutical and biotechnology industries in the collection and evaluation
of data. The company was
incorporated in Maryland in December 1997.
The founder of the company, William R. Fairweather, PhD, PSTAT(R)
is an internationally recognized, expert regulatory statistician and an ACCREDITED PROFESSIONAL STATISTICIAN(R). Dr. Fairweather provides
statistical consultation and services for clinical trial design and analysis, chemical
stability studies, animal toxicology studies and carcinogenicity studies. These studies may be submitted for Investigational New Drug Applications
or for New Drug Applications or the corresponding forms in the Center for Devices and Radiological Health or the Center for Biologics.
Services include:
- - study designs to optimize power and sample size
- - data analysis and interpretation of results
- - preparation of reports
- - electronic submission of data to regulatory authorities.
William Fairweather has extensive experience in regulatory statistics in both the clinical and preclinical areas.
He was for 25 years a statistical reviewer, supervisor, and manager in the Center for
Drug Evaluation and Research (CDER)
of the US Food and Drug Administration.
His expertise includes drug quality, stability (including matrixing and bracketing),
animal carcinogenicity, clinical trials, data integrity, and information technology.
Contact Flower Valley Consulting, Inc. today, and put his 40+ years of professional experience to work for you.
Flower Valley Consulting, Inc.
15405 Narcissus Way
Rockville MD 20853
301/929-9052
wrf343 AT FlowerValleyConsulting DOT com
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