| Study: | The program included 4 migraine studies; 2 in Phase II and 2 in Phase III. |
| Services Provided: | Project management, clinical monitoring, site management, vendor management, medical monitoring, pharmacovigilance, data management, regulatory review, and medical writing. |
| Challenges: | Meet enrollment and study timelines, despite changes in the migraine study environment during the five years in which these studies have been conducted for this client. In particular, screen failure rates have increased since the first study was conducted. |
| Solutions: | Weed out low-enrolling and poor-quality sites. Ensure that a sufficient number of sites are initiated and held in back-up mode to overcome the increasing screen-failure rate. |
| Outcome: | Every study met enrollment timelines.
Every study was conducted within or under budget.
Studies led to the approval and successful launch of this therapy for treating migraine headache. |
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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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Migraine
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.