SaaS Solution automates clinical trial disclosure compliance.September 16, 2009 -
Offering collaborative and Web-based environment, Virtx Clinical Trial Registry and Results solution (Virtx CTRR) helps mid-size life sciences organizations comply with new regulations in consistent, efficient, and predictable manner. It automates compliance with global regulatory mandates and delivers best practices in regulatory information processing. Delivered via SaaS model, solution covers complete lifecycle management of disclosure process.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Original Press release
Virtify, Inc.
55 Cambridge Parkway
Cambridge, MA, 02142
USA
Virtify Delivers SaaS Clinical Trial Disclosure Solution for Mid-Market Life Sciences Companies
Web-based solution ensures compliance with global regulatory standards while reducing cost, risk, and time to market
CAMBRIDGE, Mass., Sept. 9 -- Virtify, Inc., the market leader in enterprise content compliance software solutions for life sciences companies, today announced the availability of a new, Software-as-a-Service (SaaS) solution for managing clinical trial disclosure requirements. The Virtx Clinical Trial Registry & Results solution (Virtx CTRR) is a robust offering that automates compliance with global regulatory mandates and delivers rapid ROI by delivering best practices in regulatory information processing and eliminating upfront investments in hardware, software and implementation services.
New, evolving laws and mandates from global regulatory bodies and international health organizations such as the US FDA, World Health Organization, FDAAA, India CTRI, and the EMEA Authority, have dramatically increased public disclosure requirements for clinical trials and their results. As these authorities expand the requirements, e.g. the FDA's new adverse events reporting requirement effective September 27th 2009, many life sciences companies find themselves ill-equipped to comply due to manual or out-of-date systems. Without the proper processes and technology in place, companies run the risk of costly delays, penalties and lost market opportunities. This is especially true for small and mid-sized life sciences companies that lack the adequate internal staff and resources to achieve compliance.
Virtify's new SaaS CTRR solution helps mid-size life sciences organizations comply with the new regulations in a consistent, efficient and predictable manner. The software automates internal workflow and data gathering processes, as well as external workflow with various global regulatory agencies. With its SaaS-based delivery, the Virtx CTRR solution is also able to maintain compliance with all new and emerging regulatory mandates, reducing risk, and insulating business users from the complexity of changing compliance requirements. At the same time, life sciences companies can maintain complete control of their clinical trial disclosure processes - just as they would with an in-house software solution - but at a fraction of the overall cost of ownership.
"Clinical trial sponsors of all sizes must take stock of their existing business processes and systems to ensure that accurate and compliant communication of clinical trial data is available in the public domain," said Dr. Satish Tadikonda, president and founder of Virtify. "Our SaaS-based CTRR solution enables life sciences companies of all sizes to address this challenge by managing the entire clinical trial disclosure life cycle more efficiently and cost-effectively."
Virtify's Virtx Clinical Trial Registry & Results Solution - Key Features and Capabilities
-- Collaborative, web-based environment for managing clinical trial disclosure
-- Complete lifecycle management of the disclosure process from internal review, through approvals, postings, and results maintenance
-- Ease-of-use and intuitive interface promoting greater user adoption
-- Internal workflow management and automation for improved processes and quality
-- External workflow management with regulatory agencies for improved accuracy and consistency
-- Unique submissions comparison/reconciliation feature for greater speed and efficiency
-- Up-to-date compliance with current & emerging global regulations and standards:
-- US FDA, WHO, FDAAA, CTRI, EMEA, and other authorities
-- Compliant with FDA 21 CFR and SAE/AE reporting
-- Robust validation, auditing, security, and authentication
-- Integrated search, reporting and progress monitoring
-- SaaS delivery for rapid ROI
Virtify also offers comprehensive professional services to further optimize Clinical Trial Disclosure initiatives including:
-- business process optimization to align with new standards;
-- custom implementation and data migration;
-- product and standards training; and
-- product and technical support
Virtx Enterprise Content Compliance (ECC) Software Suite
Virtx CTRR is part of the Virtify Virtx ECC Software Suite, an end-to-end, Web-based solution for managing content and compliance requirements for life sciences companies. Unlike traditional content management solutions or individual point products, the Virtx software suite provides a secure, collaborative online environment for managing regulated content throughout the entire life sciences product continuum.
About Virtify
Virtify is the market leader in Enterprise Content Compliance 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 Virtx 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.
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