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JMP® Clinical
- CDISC Enables Efficient Streamlining of Clinical Trial Safety EvaluationIn this paper we discuss clinical trial summary information and follow the flow of FDA New Drug Application (NDA) submissions, Clinical Reviews (CR) and Biosimilar Multi-disciplinary Evaluation and Review (BMER) to reveal how the various domains of SDTM and ADaM are used to assess drug safety.
- Ferring Pharmaceuticals & NNEJMP Clinical enables Ferring to implement a custom centralized statistical monitoring program designed by consultancy NNE.
- Roche UKA forward-thinking statistical monitoring program helps ensure smooth and accurate regulatory filings.
- AlmirallData scientists build a data management standard for medical monitoring and regulatory compliance.
- accantecGerman consulting firm accantec uses JMP Clinical to monitor clinical trial data.
- MedytoxA Korean biopharmaceutical trailblazer prepares to enter the global market by ‘strengthening internal infrastructure and improving clinical quality.’