Oracle Health Sciences Clintrial is a comprehensive, multilingual, regulatory-compliant clinical data management system used to collect, manage and review clinical data. It is used by more than 200 life sciences companies worldwide to enhance data quality for paper-based trials, integrate hybrid trials, and gain increased real-time data access for a variety of clinical scenarios.
A roles-based clinical database management system, Oracle Health Sciences Clintrial allows users access to the areas of functionality they are permitted to use. The software’s intuitive environment enables users to create and maintain a clinical database without needing to be an Oracle database expert. It also 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.
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
Provides configurability and proven scalability
Can accommodate clinical study designs of various sizes and levels of intricacy
Facilitates rapid, direct clinical data entry and management through an intuitive user interface that mirrors the workflows of paper-based clinical trials
Supports multi-site, multinational clinical research trials
Can fully support industry standards
Provides a built-in library of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) version 3.1 compliant panels
Provides a working model to use for importing and exporting CDISC files, saving the time and resources required to build a CDISC SDTM-compliant library
Provides a full range of built-in CDM capabilities, including functionality for coding with standard or custom dictionaries and reporting and query tools
Integrates with Oracle Health Sciences Central Coding software, which supports five-part MedDRA and seven-part WDO-DD coding functionality
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
Offers flexibility when purchasing, deploying and expanding through a modular design
Sets up and installs quickly and takes little work to maintain and upgrade
Minimizes the need for Oracle Database expertise on-staff with an easy-to-use interface