In Consulting Services

PharmaNet offers a comprehensive range of early- and late-phase consulting services on topics including: international regulatory affairs; scientific and medical affairs; quality; risk management; chemistry, manufacturing and controls; as well as biopharmaceutical investor issues.

Biostatistics

PharmaNet Consulting employs experienced biostatistics professionals who will focus on your research requirements and design an efficient and statistically valid program. Their advice is custom-tailored at every key point from the earliest stages of clinical development planning to the final presentation of data. They offer expert guidance to optimize the statistical design and analysis of studies in a broad spectrum of therapeutic areas, with specialties that include:

 

Protocol development
Sample size calculations
Randomization techniques
Statistical analysis plans
Interim analysis and adaptive designs
Data monitoring plans and group-sequential stopping boundaries
Organizing and participating in Data Monitoring Committees
Review and validation of statistical output
Validate commercially-Planning integrated summaries of safety/efficacy kits
Interactions with regulatory agencies
Preparation for advisory committee meetings

 

 

PharmaNet professionals available for consultation in these areas include:

 

Mary F. Johnson, PhD

Executive Vice President, Biostatistics


Mario Tanguay, BPharm, PhD

Vice President, Scientific and Regulatory Affairs, Anapharm

 

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390