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JMP Clinical 17 Sam Gardner JMP Clinical 17 Sam Gardner

JMP Clinical 17 Sam Gardner - PowerPoint Presentation

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Uploaded On 2024-02-02

JMP Clinical 17 Sam Gardner - PPT Presentation

Senior Product Manager for Health and Life Sciences SamGardnerJMPcom What is JMP Clinical JMP Clinical is a focused and specialized product for Clinical Trial data review We give users straight outofthebox functionality to do thorough reviews of clinical trials at the study site ID: 1043763

jmp clinical product data clinical jmp data product reports standards medical cdisc study model utilize trial regulatory review approach

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1. JMP Clinical 17Sam GardnerSenior Product Manager for Health and Life SciencesSam.Gardner@JMP.com

2. What is JMP Clinical?JMP Clinical is a focused and specialized product for Clinical Trial data review. We give users “straight out-of-the-box” functionality to do thorough reviews of clinical trials at the study, site, and subject levelUtilized across the pharmaceutical industry and regulatory agenciesOverview

3. Data Standards Enable SolutionsJMP Clinical utilizes Clinical Data Interchange Standards Consortium (CDISC) data standards Study Data Tabulation Model (SDTM)Analysis Data Model (ADaM)These data standards are mandated for new drug product submissions to regulatory authorities in the US and Japan, and recommended in many other regionsHaving a well-defined data model allows us to develop standardized approaches for analyzing and visualizing clinical trial results. JMP has been deeply involved with CDISC for many years and we have contributed to the development of these standardsJMP Clinical Utilizes the CDISC Data Models

4. JMP Clinical 17Re-engineered to be a JMP only product.Previous versions utilize SAS for data processing and analysisIt was time for an update of the product to utilize JMP onlyMajor effort to do a complete re-write of the software codeLeaner, Simpler, FasterSmaller installation package (from >12 GB to 1 GB) for easier deployment and faster installationSimplified reports launch immediately and there are more dynamic options for each reportReady-to-use clinical review reportsReports can be published to JMP Live 17JMP Clinical 17 is be available for both Windows & MacOSJMP Clinical 17 come with all the features of JMP Pro 17A Fresh Approach

5. Delivering the ProductJMP Clinical 17.0 delivered with 30 Reports (November 2022) for safety and medical monitoringJMP Clinical 17.1 will add more reports (April 2023) including FMQ and aFMQJMP Clinical 17.2 will be the final full-featured version (Sept 2023)Staged Approach

6. New ReportsFDA Medical Query and Algorithmic Medical Queries Study Flow (CONSORT) diagram Events/Interventions Risk Reports Patient Profiles are now a standalone reportIncluded in version 17.0/17.1

7. Demonstration

8. Thank You!Questions?