Virtify Addresses Global Disclosure Complexity for Life Sciences
Washington, D.C., from the DIA Annual Meeting - June 14, 2010 - Virtify, Inc. today 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 first and only disclosure solution that automates compliance through dynamic, real-time validation of more than 5,200 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 - without custom coding or costly system redesign.
New laws and mandates in the U.S. and across the globe have dramatically 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. Compounding the issue, 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 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 critical capability is made possible through Virtify's unique architecture and XML Rules InjectionTM technology which enables rapid alignment with new registries on top of a single code base - without modifying source code. By managing Global Disclosure from a single platform, life sciences organizations will be able to easily translate and reuse content, maintain cross-registry consistency, and keep costs and corporate risk in check.
Key features of Virtify's CTRR Enterprise 2.0 include:
- A unified, state-of-the-art, web platform architected to meet U.S. disclosure today - as well as the growing list of 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
Virtify is exhibiting at the DIA Annual Meeting, June 13-17 in Washington D.C. Please visit the company at Booth 1527. Virtify CTRR Enterprise 2.0 will be available to customers in Q3 2010.
Virtify is the market leader in Enterprise Content Compliance (ECC) software solutions for life sciences. Organizations rely on Virtify solutions to reduce time-to-market, risk, and costs by managing and automating the complex regulatory compliance and content exchange requirements throughout the product life cycle. Virtify's easy-to-use ECC software suite is the industry's only solution to provide a secure, collaborative web-based environment for managing regulated content throughout the entire continuum - from pre-clinical through product registration to commercialization. The company plays a leadership role in the development of global regulatory standards and is an active participant in a variety of standards committees. Virtify's software products combined with comprehensive professional services and deep domain expertise enhance quality and compliance for some of the world's leading life sciences companies. Located on the Web at www.virtify.com