JMP^® Clinical

• Article 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.
• Customer Story Ferring Pharmaceuticals & NNEJMP Clinical enables Ferring to implement a custom centralized statistical monitoring program designed by consultancy NNE.
• Customer Story Roche UKA forward-thinking statistical monitoring program helps ensure smooth and accurate regulatory filings.
• Customer Story AlmirallData scientists build a data management standard for medical monitoring and regulatory compliance.
• Customer Story MedytoxA Korean biopharmaceutical trailblazer prepares to enter the global market by ‘strengthening internal infrastructure and improving clinical quality.’