Recogniti DataClinica is based on the OpenClinica open source for clinical research project, and is a powerful, industry leading solution for capturing and managing clinical trial data.
It allows building custom studies, design electronic Case Report Forms (eCRFs), and conduct a range of clinical data capture and clinical data management functions. DataClinica is a 100% secure, cloud-hosted, web-based clinical trials software for electronic data capture (EDC) and clinical data management (CDM). DataClinica facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. DataClinica solution is HIPAA and 21 CFR Part 11 compliant, and follows other regulatory guidelines. It is designed as standards-based, extensible, and modular platform built on a modern architecture using leading open standards.
At a high level, the Recogniti DataClinica solution features include:
• Submit Data: Intuitive interface for subject enrollment, clinical data capture, validation, and query management.
• Monitor and Manage Data: Tools for data cleaning, clinical data management, and site monitoring.
• Extract Data: Custom define and obtain clinical datasets in real-time, and in a variety of formats.
• Study Build: Design tools for configuring your study protocol: sites, eCRFs, edit checks/rules, users, and study event definitions.
• User Roles: Designate appropriate access for both site-level and study-level users.
• Administration: Tools for overall system oversight, auditing, configuration, and reporting.
• Organization. Organize your clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure manner.
• CRFs. Dynamic generation of web-based CRFs for electronic data capture with validation logic defined in reusable templates.
• Patient Visits. Management of longitudinal data for complex and recurring patient visits.
• Data Integrations. Automated and manual capabilities for import, export, and data interchange data with other systems.
• Automation. Rules engine performing advanced validation of study data and define automated actions within the system.
• Compliance. Enables compliance with Good Clinical Practice (GCP) and regulatory guidelines such as 21 CFR Part 11 via differentiated user roles and privileges, password and user authentication security, electronic signatures, SSL encryption, de-identification of Protected Health Information (PHI), and comprehensive auditing to record and monitor access and data changes. Fully validated software development lifecycle (SDLC).
• Scalability. A robust and scalable technology infrastructure developed using the Java J2EE framework.
• Extendibility. Modular architecture incorporating web services for extensibility.