clinical data review

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

Clinical Data Review provides a framework and tools for development and rapid deployment of advanced statistical & graphical summaries on-line or in portable file formats. When deployed in conjunction with Clinical Graphics & Safety Data Analysis, 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