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Technology Partners

Veristat has a strategic partnership with Phase Forward, the leading provider of data management solutions for clinical trials, offering proven solutions in EDC, clinical data management (CDM), and applied data standards.

InForm™

For electronic data capture studies, Veristat uses Phase Forward’s EDC system, InForm™. Veristat has experienced in-house, InForm database developers allowing the company to provide cost-effective and efficient solutions for our clients. InForm™ is the most scalable EDC technology available. There are no limitations to study size (small to very large), and global support is unmatched. InForm™ offers unparalleled reporting with:

• 32 robust, ready-to-run standard clinical operations reports
• Ad hoc reporting with a drag-and-drop interface, for virtually all operational and clinical data available through an easy user interface
• On-demand layout changes including tabling, charting and data grouping

InForm™ is a true thin-client web-based technology. There are no site SOPs for data back-up / retrieval / archival during the trial because there is no local data or applications resident at the clinical site. Additionally, the system has intuitive navigation to support quick user adoption.

Clintrial™

For paper-based studies, Veristat uses Phase Forward’s Clintrial™ system. The Clintrial™ product offers a complete set of features for streamlining data entry, discrepancy management and resolution, patient and site reporting, data exporting, and system administration.

Highlights of Clintrial™ include:

• Production-proven clinical data management system that is scalable, having been deployed to manage thousands of clinical trials accommodating clinical study designs of various sizes and levels of intricacy.
• 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 Part 11 compliance for electronic record and signature use.

WebSDM™

For applied data standards in electronic submissions, we have partnered with Phase Forward's Lincoln Technologies safety division, to implement the Web Submission Data Manager (WebSDM™) application, the same application used by the FDA, to load and validate compliant SDTM-format study data. In addition to utilizing WebSDM, we have developed a suite of additional validation checks for data consistency and CDISC compliance. This technology ensures submission files conform to the SDTM standard so that our clients can present them to regulatory agencies with confidence.