Organization of 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 and transparent manner.
Easy and Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters. Supports versioning of CRF for re-use across studies.
Centralized Trial Management Database.
Management of longitudinal data for complex and recurring patient visits.
Data import/export tools for migration of clinical datasets in excel spreadsheets, local databases and legacy data formats.
Extensive interfaces for data query and retrieval, across subjects, time, and clinical parameters, with dataset export in common statistical analysis formats
Compliance with HIPAA privacy and security guidelines including use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.
A Robust and Scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including Postgreas (open source) and Oracle 10G, to support the needs of the clinical research enterprise.
Support for system oversight, auditing, configuration, and reporting
Double data-entry support, and reconciliation with built-in discrepancy/query management
Data output to common statistical analysis formats.
Data model based on CDISC standards for interoperability
