| Study: | Phase II Parkinson’s disease study with more than 350 participants at 31 sites in the US and Canada. The project comprised both a dose-ranging study and an open-label safety study. |
| Services Provided: | All services required for a Phase II study. |
| Challenges: | To take over the project from another CRO.
When PharmaNet was first brought into the project, both studies were 4 months behind in projected enrollment.
When PharmaNet assumed total responsibility for the project, only 12 of 31 sites were active in the dose-ranging study and none of the 31 sites were active in the open-label safety study. |
| Outcome: | Within 30 days, all sites were active in the dose-ranging study. The PharmaNet Neuroscience team managed the study so effectively that enrollment ended 30 days ahead of the original projection.
The open-label safety study was so effectively managed that no subjects missed entrance.
This client subsequently awarded PharmaNet 2 additional dose-ranging studies, 3 Phase III studies, and 2 open-label safety studies. Those studies resulted in 2 positive pivotal trials and an NDA submission. |
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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. |
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Parkinson’s Disease, Phase II
PharmaNet Development Group, Inc.
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390
© 2008 PharmaNet Development Group, Inc. All rights reserved.