Flower Valley Consulting, Inc provides statistical advice and consulting services to the pharmaceutical industry in the collection and evaluation of data of chemical stability studies, animal toxicology studies, carcinogenicity studies, and clinical trials.

To a company developing a chemical into a useful drug, its most valuable attribute is the information available about it. Regulators and companies that acquire promising drugs want to know not only what the drug does but also HOW GOOD are the data supporting these claims.

Of course, you need to develop statistics to show that the chemical is stable, biologically active against a disease process, and reasonably safe. "Good statistics don't happen by chance" is our motto because we know that good statistics can only be derived from well designed studies of sufficient size that address the scientific and medical issues that concern regulators. Moreover, your data must be readily available and your statistical analyses and summary reports must be entirely consistent with the data. As a longtime regulator, I know that nothing stops the approval process faster than a report that appears to be inconsistent with the data, one that appears to conceal a problem, or a dossier or application made up of poorly designed or executed studies.

Every study design is a compromise, limited by feasibility and finances. And every study is subject to flaws in execution. Our objective is to minimize these problems by careful planning and design, and to address any unexpected events completely and in the context of the study. When we finish with your study, you should have a solid foundation to support your data, your study, and your conclusions.

Flower Valley Consulting, Inc. has strategic partnership arrangements with several other companies so that we can bring additional, nonstatistical expertise to the attention of our clients in case it is necessary. This allows us to serve our clients more effectively.

Our clients have included
Adams Respiratory Therapeutics
Alitair, Inc.
Alkermes
Allergan, Inc.
Alteon Pharmaceuticals
Amerimmune
Berlex
Biofem
Biomarin
Biostar, Inc.
Cadence Pharmaceuticals
Camlin Pharma
Endo Pharmaceuticals, Inc.
Fujisawa Healthcare, Inc.
GanTech Biotech
GenVec, Inc.
HeteroGeneity, Inc.
Ipsen Ltd
Janssen Pharmaceuticals
Layton Biosciences, Inc.
Merck Research Laboratories
Metabolex
National Institute for Drug Abuse
Novartis Consumer Health, Inc.
Novartis Pharmaceutical Corp
PATH - Malaria Vaccine Initiative
Provensis, Inc.
Relypsa, Inc
Schering-Plough Research Institute
United States Pharmacopeia