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JMP Live Integration |
Development Safety Update Reporting/ Periodic Safety Update Report (DSUR/PSUR) |
Medical Query Risk Report |
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ABOUT
What does this feature do?
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Users will be able to publish JMP Clinical reports to JMP Live and will be the primary tool for our consumer user roles. |
Pharmacovigilance responsibilities often include submitting DSUR and PSUR reports to the FDA to better track ongoing safety issues. |
Signal detection determining the risk of adverse events, body system and standardized MedDRA queries is essential for understanding the safety of a drug. |
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PROBLEM
What customer problems/pain does this feature address?
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Users (Medical Monitors and MDs) who are sharing reports with others, such as executives who are non-JMP users.
IT: Sharing data with JMP Clinical clients
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Every six months drug safety programmers need to update standard tables and listings for the latest clinical trials data to submit to regulatory agencies. |
Updating standardized medical query (SMQ) reporting is both time consuming and error prone. Versioning of SMQ's also make this process even more complex. |
BENEFITS
What does this feature allow customers to do that they couldn't do before? What is the impact of change? |
Personal Benefit: With JMP Live dashboards consumers won't need to know anything about the JMP Clinical client.
Company Benefit:
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Automates the gathering of required reporting components and facilitates integration of this information with patient profiles and narratives. |
JMP C 8.0 has simplified the presentation of signals for all these levels simultaneously. Help sponsors and regulatory agencies evaluate the risk differences of treatments across Standardized Medical Queries or tailored Medical Queries. |
| Which Phase/Stage of the Clinical Trials do each of these apply? |
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TARGET TITLES/ROLEs
Who would benefit from this feature?
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Medical Monitors, Data Monitors and Data Scientists at pharmaceutical and biotech companies or CROs engaged in running clinical trials in phases I-IV. |
Safety teams involved in submitting DSUR/PSUR to the FDA or other regulatory agencies. |
Biostatistics, Biometrics, Clinical Data Scientists and Medical Doctors interested in looking at diseases defined by medical queries. |
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KEYWORDS
What should a sales person listen for on calls?
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- collaboration
- sharing information
- data silos
- access to reports
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- Pharmacovigilance
- Drug safety
- safety update reporting
- post market
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- medDRA
- SMQ
- Standardized Medical Query
- Risk difference
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QUALIFYING QUESTIONS
What should i ask to see if a prospect is a good fit?
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- How are you currently sharing your reports across your organization?
- Is your IT organization hoping to modernize sharing for users who mainly consume reports (rather than create them) to the web?
- Do you share your results with non JMP users?
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- Does your organization have a global safety group that performs development safety update reporting or periodic safety update reporting or do you outsource that to your CRO?
- Would you like to modernize that reporting infrastructure to the web?
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- Who in your organization is in charge of Standardized MedDRA Queries?
- Are they interested in knowing more about what the FDA is doing with groupings of Adverse events to create their own FDA Medical Queries database?
- Are they aware of the FDAs internal standardization in reporting?
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| Resources |
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- Blog
- Social Content
- Mastering JMP
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