Clinical data analysis software for ensuring trial safety and efficacy
Role-based workflows, reusable templates and automated reporting tools make it easy for all key participants in the trial review process to explore trends and outliers. Detect hidden data, safety and efficacy issues via capabilities such as RECIST-based oncology visualizations, medical monitoring, data integrity validation and statistical analyses. Publish results to a secure web environment where colleagues can view your findings.
Clinical data scientists and medical monitors
Summary dashboards in JMP Clinical enable medical reviewers to evaluate safety and efficacy issues with the click of a button. Create interactive reports of adverse events, concomitant medications, labs and vital signs, and drill down to customized patient profiles and patient narratives.
Producing adverse event narratives for clinical study reports (CSRs) can be a painstaking, time-consuming process with significant consequences for inaccuracies or delays. With JMP Clinical, medical writers can automate patient profiles and patient narratives and reduce the time and complexity of creating output for review and submission to regulatory agencies.
The goal of clinical operations is to mitigate data quality risks that could hinder a regulatory submission or drug approval. Risk-based monitoring tools in JMP Clinical help you identify data anomalies at the vendor, monitor, site and country level, and determine the factors responsible for lapses in safety or data quality.
Drug safety specialists
Pharmacovigilance responsibilities often include submitting Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR) to the FDA to better track ongoing safety issues. JMP Clinical automates the gathering of required report components and facilitates the integration of this information with patient profiles and narratives.