Pharmaceuticals — Clinical Development

Use JMP or JMP Clinical to:

• Analyze mortality and serious adverse events using a combination of JMP platforms, including the Categorical or Distribution platforms, Tree Map and the Data Filter.
• Find outliers in laboratory measures, then point and click to see the data behind them.
• Monitor exposure data with safety data to determine the maximally tolerated dose (MTD).
• Use the Distribution platform to analyze and summarize exposure data, employing the histogram to quickly create dosing groups.
• Identify drug-drug and drug-disease interactions by using the table update function to merge Submission Data Tabulation Model (SDTM) domains and model them using the Partition platform.
• Explore drug effects through sub-group analysis, using the Graph Builder with the Data Filter.
• Analyze highly specific efficacy endpoint data.
• Identify trial participants who drop out early and validate disposition data.

New Drug Application (NDA) Submission

• Streamline the FDA review process with standard data and work flows.
• Take advantage of compatibility with the SDTM and the Analysis Data Model (ADaM).
• Copy and paste your results into a PDF and send them directly to the FDA at the New Drug Application (NDA) submission point.

Use JMP Clinical to:

• Identify and closely examine hidden trends in serious adverse events within safety domains.
• Cluster adverse events to reveal correlated factors, predicting possible occurrences and highlighting potential risks.
• Estimate adverse event frequency and count information with the highly visual tree map function.
• Reduce false-discovery rates, mitigating the risk of over-reporting adverse events with the Severity ANOVA.
• Measure time to event for any adverse event in a clinical trial with the industry-standard analysis methods in JMP Clinical.
• Screen all Standard MedDRA Query (SMQ) terms to discern adverse event patterns across treatment groups.
• Generate multiple reports that provide comprehensive evaluation of risk information based on predictive factors for adverse events.

Use JMP Clinical to:

• Identify outliers with sophisticated graphics that make it easy to spot and select one or more outlying laboratory values, then drill down quickly to subject-level details using patient profiles.
• Measure the change from baseline for any specific laboratory test in the trial with baseline ANOVA analysis.
• Interact with bubble plot graphs that show the rate of change for multiple lab tests, measuring trends over time across treatment groups or other categories of interest.
• Use Hy’s Law analysis to assess hepatoxicity, a focus of the FDA’s guidance on safety review.
• Display differences in values between matched pairs of patient with shift tables.

Use JMP Clinical to:

• Cluster adverse events, interventions and findings across safety domains.
• Screen concomitant medications and medical history for drug-drug and drug-disease interactions, respectively.
• Use partial correlation diagrams to infer association and potential causal relationships between a set of variables.
• Identify patterns across treatment groups with advanced multidimensional scaling capabilities.
• Prepare data sets for pattern discovery and predictive modeling by converting selected variables to 0-1 numeric values and adding them to the Subject-Level Analysis Dataset (ADSL).

Use JMP Clinical to:

• Create interactive patient profiles instantly for any individual or group of subjects simply by selecting a subject or group from a CDISC domain.
• Select patient details — adverse events, medical history, vital signs, etc. — to customize patient profiles, displaying data from any combination of safety domains.
• Move fluidly between results for the entire trial and specific patients.