Clinical Data Management

Regardless of whether you’re running a small, single Phase I trial or many, complex Phase III trials you look for ways to ensure that your organization is collecting and managing clinical data reliably, efficiently and in compliance with industry and government regulations. A small-scale scenario could involve an early-stage trial with limited patient volumes, where an organization wishes to quickly conduct a trial, entering data via traditional paper-based forms. A large-scale scenario could involve the collection of thousands of patient records, worldwide, accumulated from paper, EDC, and hybrid trials — all collected in one CDMS system as a means to store, manage and review clinical data and lab data across studies.


To accommodate these specific clinical scenarios, Phase Forward offers the Clintrial™ product, a comprehensive, regulatory compliant, clinical data management system used to collect, manage and review clinical data. The Clintrial product is used by more than 200 life sciences companies worldwide to enhance data quality for paper-based trials, to integrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.

Clintrial

The Clintrial 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. Clintrial 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 Clintrial 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.

Clintrial Highlights:

  • Production-Proven Clinical Data Management
    The Clintrial 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 Clintrial solution further supports multi-site, multinational clinical trials.

  • CDISC Support
    The Clintrial 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 Clintrial 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 Clintrial 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 design gives companies flexibility when purchasing, deploying and expanding. Clintrial 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 Clintrial product can help lower an organization’s CDMS total cost of ownership (TCO).