Virtify, Inc.
announced the upcoming release of its new Clinical Trials Registration & Results software product, CTRR Enterprise 2.0, part of the
Virtify Enterprise Content Compliance (ECC)
software suite . CTRR Enterprise 2.0 is the a disclosure solution that automates compliance through dynamic, real-time validation of built-in rules derived from
www.clinicaltrials.gov
, the FDAAA-mandated repository for clinical trials registration and results. In addition, CTRR Enterprise 2.0 is architected to support new PRS rules as well as new international registries.
New laws and mandates in the U.S. and across the globe have increased public disclosure requirements for clinical trials and their results. In the U.S., mandated submissions to
www.clinicaltrials.gov
are bound by 2,700 unique rules regarding clinical trial registration and 2,500 additional rules for results postings; this totals 5,200 for the U.S. alone. Many countries are also establishing registries with their own deadlines and rules including the European Clinical Trials Database (EudraCT) and others.
“Any life sciences company with a global presence is preparing for a veritable administrative nightmare to keep pace with the continually changing regulatory climate. The complex and numerous rules governing disclosure make it a daily struggle to comply in a timely, efficient and profitable manner,” said Satish Tadikonda, president and CEO of Virtify. “Virtify’s new CTRR Enterprise Edition will help to enable companies to maintain full and timely compliance with these ever-changing global mandates on a single, unified platform.”
Complicating this evolving regulatory environment is the submissions process itself. “Accurately inputting what could be thousands of data points for a single clinical trial result is virtually impossible, particularly when we must abide by rules that can change without notice,” said Shahid Ahmed, co-president of Nexus Pharmaceuticals and a Virtify customer. “This is a real issue for us, since timely and accurate submissions are critical for securing a first-to-market advantage. One inaccuracy can delay approval for months.”
Virtify’s CTRR Enterprise 2.0 is designed to address U.S. disclosure rules today and emerging global registries, including EudraCT in Europe as well as others in Germany, Croatia, Brazil, India and China. This capability is made possible through Virtify’s architecture and
XML Rules InjectionTM
technology which enables alignment with new registries on top of a single code base without modifying source code.
Key features of Virtify’s CTRR Enterprise 2.0 include:
• A unified Web platform architected to meet U.S. disclosure today as well as new and emerging global registries
•
XML Rules Injection
for seamless, rapid alignment with emerging International registries and changes to the PRS system
•
In-line Validation
for real-time compliance with more than 5,200 business rules required by www.clinicaltrials.gov
•
Parallel Review and Approval
for real-time collaboration between mutliple authors and reviewers
• Open, extensible .NET architecture enabling integration with existing systems and databases
• Comprehensive professional services including software implementation, legacy data migration, SAS integration, regulatory & registry tracking, training and customer support
• Standard and custom reporting including audit trails
• Flexible delivery via SaaS or perpetual license
• 21 CFR Part 11 compliant
