An RBM solution offering standalone analytics or integrated risk modules
From the digitization of risk & integrated review planning to the execution and resolution of data reviews and findings, the platform offers an end-to-end seamless solution that is fully auditable and traceable.
Risk Assessment & Planning
Our robust & flexible platform allows standard risk assessments such as Transcelerate’s RACT and MCC’s Risk Assessment Tool as well as customer-specific risk assessments to be uploaded into the platform. Additionally, a risk assessment can be created, versioned and approved directly within the ThoughtSphere platform through an intuitive user-workflow with the option to export approved versions of the Risk Assessment for TMF filing.
Smart Analytics & Dashboards
ClinACT offers a robust suite of Out-of-the-Box KRIs, KPIs, QTLs, analytics & dashboards to surface data at the strategic, operational, analytical, and self-service level so users can quickly access what they need, when they need it. By incorporating predictive analytics and quality checks in our dashboards, ClinACT delivers smart insights including enrollment projections as well as the likelihood and timing of QTL breaches. Any custom data models and visualizations created in MAP and the BI Tool can easily be promoted to CLINACT to be part of the study analytics suite routinely reviewed by the project team.
Automated Risk Review Triggers
To ensure KRIs and other risk reviews are performed in accordance with study plans, cadence-based or data-driven review schedules can be defined in the Trigger studio. When a time-point or data criterion is met, the system generates a review item in the appropriate user workflow. This ensures that trial data is reviewed/processed per the agreed to study plans, and creates an audit trail entry for every item reviewed.
Holistic Subject Reviews
ClinACT’s customizable patient profiles allow users to quickly see patient summaries and toggle between data visualizations to identify correlations between different data domains at the subject level. Additionally, interactive graphs are available for data reviewers to analyze safety and/or efficacy parameters such as lab analyte and ECG changes over time simply by selecting which data domains and variables to view and the visualization instantaneously refreshes.
Customizable Data Review Workflows
ThoughtSphere platform is developed using modern web technologies, which provides intuitive user interfaces to automate risk review and data review workflows. Several user workflows are available out-of-the-box (e.g., Medical Review, Central Monitor, etc.) and custom user workflows can easily be configured. Additionally, the platform is email alert and notification enabled so users can be notified of actions assigned to them in data review workflows without logging into the platform.