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.

Managing Multiple, Multinational Programs for A Single Sponsor
Client: A mid-size pharmaceutical company conducting four simultaneous international studies in multiple myeloma. The 18-month enrollment goal of the four studies was 1,100 patients across 200 sites located in North America, Western Europe, Eastern Europe, and Australia.
   
Challenge: The programs faced three major challenges: simultaneously launching four large, full-service multinational trials; maintaining investigative-site motivation throughout the projected patient enrollment period; and developing effective drug-distribution strategies due to an initial shortage of study drug.
   
Solutions: Identify areas of commonality among the programs to maximize efficiencies and shorten start-up timelines. Maintain close contact with investigators and study coordinators to sustain motivation. Implement a site-by-site distribution plan to ensure adequate drug availability for those sites actively enrolling patients.
   
Outcome: Enrollment was completed ahead of schedule. Data from these studies resulted in regulatory approvals in the US and Europe.
PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390