| Client: | Small biotechnology company |
| Challenge: | Compile and integrate legacy data from 23 diverse phase I-II studies into a format acceptable for NDA submission. |
| Outcome: | Within 3 months, biostatistics and data management professionals from PharmaNet Consulting developed and implemented a plan to systematically import, document, and pool data from the 23 studies into a format that could be used to prepare FDA-compliant integrated safety summary and electronic data files. |
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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. |
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Clinical and Product Development
Key Product Areas
Chemistry/Manufacturing Controls
Quality Assurance/Quality Control
Consolidating Legacy Data
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.