|
The TrialPro product offers a complete set of features for streamlining data entry and lab loading, discrepancy management and resolution, patient and site reporting, data exporting, coding and system administration. TrialPro is a roles-based clinical database management system that allows users access to the areas of functionality they are permitted to use. The product’s intuitive environment enables users to create and maintain a clinical database without needing to be an Oracle® DBA or database expert. The TrialPro software enables life sciences companies to unify their clinical data management needs, regardless of the source (EDC or paper) into one system that can be fully integrated with other ancillary systems.
TrialPro Highlights:
· Production-Proven Clinical Data Management
The TrialPro product provides configurability as well as proven scalability, having been deployed to manage thousands of clinical trials per client*. The product can accommodate clinical study designs of various sizes and levels of intricacy. The product's intuitive user interface, which mirrors the workflows of paper-based clinical trials, facilitates rapid, direct clinical data entry and management. The TrialPro solution further supports multi-site, multinational clinical trials.
· CDISC Support
The TrialPro product can fully support industry standards and provides a built-in library of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) version 3.1 compliant panels. Customers benefit from having a working model to use for importing and exporting CDISC files, and they further benefit from the reduced time and resources required to build a CDISC SDTM-compliant library.
· Extensive Coding and Reporting Features
The TrialPro product provides a full range of built-in CDM capabilities including functionality for coding with standard or custom dictionaries and reporting and query tools.
· Regulatory Compliance
The TrialPro product can be deployed as part of a validated system that complies with Good Clinical Practice (GCP) predicate rule requirements, laws and regulations for clinical trial conduct, and FDA 21 CFR 11 compliance for electronic record and signature use.
· Low Total Cost of Ownership
The product's modular, web-based design gives companies flexibility when leasing/purchasing, deploying and expanding. TrialPro software sets up and installs quickly and takes little work to maintain and upgrade. Its easy-to-use interface minimizes the need for Oracle® database expertise on-staff. In short, the TrialPro product can help lower an organization’s CDMS total cost of ownership (TCO).
|
