In Phase II-IV

PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors.

Biostatistics

PharmaNet offers a complete range of biostatistical services, including:

 

Protocol development, including sample size and power calculations
Randomization schedules
Statistical analysis plans
Statistical programming in SAS®
Statistical analyses using current methodologies
Interpretation and reporting of data for clinical trial reports and publications
Regulatory representation
Interim analysis and DMC support
Database integration (ISS/ISE preparation)

 

The PharmaNet Biostatistics team is distinguished by a large library of published papers. Please click here to see a partial listing.

 


Mary F. Johnson, PhD

Executive Vice President, Biostatistics

Dr. Johnson has served as a statistical consultant to the pharmaceutical industry for more than 18 years, advising clients on both statistical and regulatory aspects of clinical development programs. She previously spent 8 years at the FDA as a group leader and statistical reviewer in the Division of Biometrics. As PharmaNet’s Executive Vice President, Biostatistics, Dr. Johnson has managed statistical analysis and programming activities for clinical trials in numerous successful NDA/PLA submissions.

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