November 01, 2010 10:55 ET

Sylogent Releases VCTR 2.1 Clinical Registry Solution

Delivers Significant Time and Cost Savings to Customers for Clinical Trial Registration and Results Disclosure

NEWTOWN, PA--(Marketwire - November 1, 2010) -  Sylogent today announced the release of the 2.1 version of its Clinical Trial Registration and Results Disclosure solution, VCTR (Victor).

"Current customers are anticipating significant savings in cost and time, as well as improvements in data accuracy, as a result of this release," stated Jack Yeager, CEO of Sylogent. "Exporting data from SAS and importing it into VCTR will mean that customers will no longer be relying on expensive and frequently overstretched professionals to manually enter this complex dataset."

Industry statistics indicate that manual data entry into the FDAAA format can take between 20 and 40 hours and often requires significant input from highly compensated resources such as biostatisticians.

"Part of the challenge sponsors face is that SAS only offers limited export to XML capabilities, requiring subsequent transformation into FDAAA format," stated Yeager. "We solved this problem by developing a proprietary flat file data format so that customers can get data out of SAS quickly and easily, and then import it into VCTR with just a few clicks. Once in VCTR, data is transformed into FDAAA format, validated, and ultimately routed through configurable review and approval processes prior to posting to the registries."

Sylogent provides customers with the option to import any individual FDAAA result section (such as Adverse Events), or all major data-intensive sections, offering up to 90% of data entry automation.

The company worked closely with SAS programming teams from two leading pharmaceutical customers to perfect the schemas and data import process, which was extensively tested prior to production launch.

Additional new features in the 2.1 VCTR release include:

• Enhanced collaborative review processes
• Ability to import files to each study record, store them, and selectively post to corporate or registry websites (in anticipation of possible rulemaking)
• Delayed result posting request, with subsequent completion and storage of the full FDAAA format record until the 30-day post-approval posting window
• Full integration with optional client registry module

"We focus on delivering the best service, solutions and value for our clinical data disclosure customers," stated Yeager.

VCTR

The major features of VCTR and associated expert consultancy include:

• Simple import of results and other data using standard XSD schemas
• Seamless integration of new compliance requirements based on current and future legislation
• Verifiable audit trail and full transparency into posting status for confident compliance
• Validated and accessible web solution for efficient workflow routing throughout the global enterprise
• Automated posting to US registry websites such as clinicaltrials.gov, clinicalstudyresults.org, and to sponsors' clinical registry websites
• Patient response services via online patient screening and routing to participating trial sites

For additional information, please visit: www.vctr2.com

Sylogent

Sylogent helps its customers to maximize operational efficiencies through the standardization and flow of data throughout their clinical development and regulatory process.