| Client: | Mid-sized, Japanese pharmaceutical company with little experience outside Japan |
| Challenge: | Create a clinical development plan for a product that accelerates fracture healing. The client needed a plan that would satisfy global regulatory authorities and enable it to market the product with affiliates in Europe and the US. |
| Outcome: | A PharmaNet team with experience in pre-clinical and clinical development planning in both Europe and US assessed the product and its clinical environment, produced a clinical development plan, and delivered an estimated protocol synopses for the phase II and III pivotal studies. With PharmaNet's assistance, the client produced a credible plan to bring the product to market in Europe and the US, obtained FDA approval of its plan, and is now proceeding with trials. |
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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
Clinical Development Plans
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
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