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Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future

The identification of different responsibilities, under the clear leadership of the medical writer, is necessary to improve the quality of clinical study protocols – to prevent problems and mistakes that can result later, during conduct of the clinical trial, or afterwards, when reporting on trial results.

Author(s): Kelley Kendle
Solution: Drug Development & Regulatory Strategy, Regulatory & Medical Writing
Publication: Medical Writing
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Extending the Use of Antivirals to Treat Influenza in Infants

Scientists from d3 Medicine—part of Certara’s Strategic Consulting division—helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.

Solution: Biosimulation, Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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