ClinicalAnalytics

ClinicalAnalytics is a comprehensive eClinical Suite offered by TrialStat Solutions Inc. According to the vendor, this platform serves as a unified solution for managing clinical trials and collecting and analyzing study data. It is designed to streamline and simplify clinical data management and is suitable for companies of all sizes, from small biotech startups to large pharmaceutical corporations. ClinicalAnalytics caters to a range of professionals and industries, including clinical research professionals, data managers, clinical operations managers, clinical trial coordinators, and biostatisticians.

Key Features

eConsent Module: According to the vendor, the eConsent module aims to streamline trial enrollment and maximize protocol compliance. It offers configurable workflows, support for witnesses, assent, re-consent, and the ability for patients to revoke consent. The module is fully integrated with TrialStat's EDC platform, allowing immediate access to eConsent information within the study.

ePRO (Patient Reported Outcomes) Module: The integrated ePRO module allows for the easy and secure capture of patient-reported data, according to the vendor. Users can design custom questionnaires or integrate existing validated instruments. The module is 100% web-based and works seamlessly on all tablets and mobile devices. It supports multilingual capabilities and allows for patient notifications.

Randomization / IWRS (Interactive Web Response System) Module: According to the vendor, TrialStat's integrated IWRS functionality enables any degree of randomization complexity. It offers various randomization methods, including simple randomization, block randomization, and permuted block randomization. The module allows for randomization into different cohorts and integrates with inventory management.

Medical Coding Module: The medical coding module, as claimed by the vendor, ensures fast and accurate coding of verbatim terms from both the EDC system and external sources. It guarantees accurate coding results with advanced algorithms and comprehensive dictionaries. The module significantly reduces coding time and effort by providing suggestions based on context and previous coding decisions. It integrates regularly updated dictionaries, including MedDRA and WHODrug, to ensure compliance with industry standards.

Integrated Safety Event Tracking: TrialStat's EDC system includes a module for tracking and managing safety events, according to the vendor. Users can design adverse event (AE) and serious adverse event (SAE) forms directly within the system. The module allows for the completion of narratives and generation of regulatory forms such as MedWatch without the need for a separate system. It also integrates with third-party safety and CTMS systems for seamless data flow.

Browser-Based & Mobile Responsive: According to the vendor, TrialStat's eClinical Suite is accessible from any web browser, mobile device, tablet, laptop, or desktop computer. The platform does not require proprietary browser plugins or desktop software installations. It is designed to provide a consistent user experience across different devices.

Real-Time Monitoring, Reporting & Validation: TrialStat offers real-time monitoring, reporting, and validation of study data, as claimed by the vendor. Users can access real-time data visualization, configurable reports, and dashboards. The platform provides comprehensive edit checks, dynamic skip logic, and customizable data review status workflows. It supports integrated real-time reporting and offers over 40 standard reports.

Data Drill-Downs: According to the vendor, TrialStat allows users to drill down into their data with interactive reports. Users can access detailed information and perform data analysis at various levels, from individual subjects to the entire study. The platform supports data drill-downs for in-depth exploration and analysis.

CTMS Integration: The vendor states that ClinicalAnalytics can be integrated with Clinical Trial Management Systems (CTMS) for comprehensive study management. This integration aims to facilitate efficient study planning, budgeting, and tracking. It also helps streamline site selection, enrollment, and monitoring processes. The integration provides seamless data exchange between ClinicalAnalytics and CTMS.

Vendor Neutral Imaging Archive (VNA): According to the vendor, ClinicalAnalytics includes a vendor-neutral imaging archive that serves as a centralized repository for storing and managing medical images. The archive supports DICOM image viewing and analysis and ensures interoperability with various imaging systems and formats. It enables secure and controlled access to images for authorized users.