Clinical DAta Review

Insightful Clinical Review

The cost of clinical trials continues to increase. Clinicians require rapid and guided access to clinical data for critical decision making, especially to ensure that all safety issues are being identified and communicated. Insightful Clinical Review enables interactive, web-based viewing of clinical data from early and late phase clinical trials. The framework includes summaries from graphical and statistical analyses of adverse events, labs and treatment, with drill down to patient profiles that summarize all available data at the patient level.  Insightful Clinical Review utilizes advanced S-PLUS statistical graphics and analytics for efficient communication of clinical information in the trial data:

• Identify safety issues quickly
• Guided data review for clinicians, ensuring best practices
• More and better information exchanged in meetings - internally and with regulatory agencies

Insightful Clinical Review provides a framework and tools for development and rapid deployment of advanced statistical and graphical summaries on-line or in portable file formats. When deployed in conjunction with Insightful Clinical Graphics and Insightful Safety, Insightful Clinical Review assists in providing a comprehensive graphical environment for the examination and communication of your data and results for all phases of your clinical trials in progress.

Select adverse event and/or lab summaries then drill to patient profile. Clinical graphics / statistics menu on left and on-top banner may be configured to customer requirements.

Improve the quality of decisions

• Select the best dose in early-phase trials
• Identify patients with lab and/or AE issues early in all trials
• Identify potential data errors and enable data cleanup
• Discern safety and efficacy signals in all early and late phase trials

Speed the drug development effort

• Comprehensive data display at the fingertips of your entire team
• Real-time review of all trial data
• Interim analysis of safety and efficacy
• Appropriate attrition and advancement of compounds

Enable better interactions with regulatory agencies

• Online and portable trial summary enables in-time support of FDA interaction team for FDA meetings

For more information on the Insightful Clinical Data Review solution, please contact us via email or call in the US/Canada (800) 569-0123, UK +44 (0) 1256 339800, or Basel +41 61 717 9340.