Clinical Trial Management
Clinical trial management is highly data intensive and complex. It requires tracking site activation, monitoring enrollment in real time, managing protocol deviations, and accounting for investigational products.
Site Activation and Feasibility Management
Activation milestone tracking with traffic lights
Milestones from site selection, IRB submission, approval, SIV, and first patient enrolled are tracked against planned dates with traffic light status showing which sites are at risk.
Feasibility data and site selection scoring
Site feasibility questionnaires are collected, scored, and compared in the CTMS, supporting site selection with structured, comparable data instead of ad hoc CRA judgments.
Regulatory submission status by country
Country-level regulatory submission status (CTA submitted, under review, approved, or info request) is tracked by site and country, with overdue approvals automatically escalated.
Enrollment Tracking and Forecasting
Real-time enrollment against target
Actual enrollment by site, country, and study is tracked against targets in real time, with trend analysis showing if current enrollment will meet the study timeline.
Screen failure and randomization rate tracking
Screen failure and randomization rates are tracked by site and investigator, showing which sites screen well but enroll poorly and which do not screen enough patients.
Enrollment projection modeling
Enrollment projections use current site performance to estimate scenarios and finish conclusion, and which sites need to increase the study conclusion.
Protocol Deviation Management
Structured deviation recording by type and severity
Protocol deviations are recorded in structured forms that classify type, severity, and causality (link to the protocol section) and assign to the site and investigator.
Deviation frequency monitoring by site
Deviation frequency is tracked by site, category, and investigator, with alerts when rates exceed the study average, supporting targeted monitoring and coaching.
Corrective action tracking
Each deviation triggers a corrective action plan with an owner and due date in the CTMS, including configurable post-implementation effectiveness tracking.