BOSTON, June 24, 2013 /PRNewswire/ -- DIA Conference, Booth #1647 -- Virtify, Inc., a leading innovator in content and regulatory information management solutions for the life science industry, today announced the release of Virtify SCM, a new software platform for creation, reuse and tracking of clinical and regulatory content. Virtify SCM (Structured Content Management) takes an asset management approach to improve collaboration and enables the automation of documents used throughout the drug product life cycle – from pre-clinical through product registration to commercialization. Virtify SCM improves compliance, productivity and quality while reducing risk across the drug product portfolio.
"Clinical and regulatory content contained in mandated documents are vital assets, often supporting drug development for decades. Yet inefficient management of clinical content can handicap the enterprise in the face of changing markets and regulatory needs," said Satish Tadikonda, President and CEO of Virtify, Inc. "Virtify SCM's seamless management of clinical information results in competitive advantage for the life science company. Virtify SCM evolves content management to a new level of ease and sophistication, delivering near-term risk reduction and cost savings with long-term improvements in operational efficiency."
Virtify SCM is a secure, collaborative, web-based environment for managing regulated content through linked data components that automate and track all information known about a product, trial or objective at all stages of the development. Virtify SCM uses business rules-based templates and builds a library of re-useable content. It leverages organizational data across all operations, including R&D, submissions, labeling and marketing. Virtify SCM makes global regulatory compliance more routine, maximizing resources and producing more and better products in less time.
According to industry analyst firm IDC Health Insights, a new drug costs from $800 million to $1.2 billion to bring to market, and a quarter of this cost is content and regulatory requirements. Traditional document management approaches slow processes and isolate data. This promotes inefficiencies and risk in reporting, planning and regulatory affairs.
Benefits of Virtify SCM
Virtify SCM takes a new approach to managing clinical content to gain better insight into clinical operations. Benefits of Virtify SCM include:
- Boosts Efficiency with Content Library. Virtify SCM leverages company content in a secure, searchable library of linked core data components. Content users receive notification when any applicable content is updated. Current regulatory forms and processes are also maintained. This master control facilitates accuracy and accountability of content assets and their growth, while reducing infrastructure.
- Reduces Time and Cost with Document Automation. Virtify SCM maximizes the reuse of core structured data and regulatory templates to build submission, labels and other documents on demand. Submission and electronic sign-off requirements are noted.
- Enhances Collaboration with Parallel Authoring. The content management and collaboration tools enable authorized workers to collaborate with a document in real time to better manage complex, multi-submission compliance requirements.
- Better Accountability with Content Tracking. Virtify SCM records variations from master content and tracks its evolution and lineage. All changes and sources are inventoried, and the document is tracked to the final submitted form.
- Ease of Use - Work the Way You Want. SCM uses a Microsoft® Word paradigm so medical writers, regulatory affairs and labeling professionals do not have to change their work flow and style practice. Rapid implementation is complemented by flexible delivery via subscription or perpetual licenses, in-house or using hosted systems.
- Business Intelligence. Virtify SCM provides a unified view into the clinical content workflow with actionable, standard or custom reports and analytics to support clinical, regulatory or executive inquiries and audits. Such analytics result in a more agile enterprise.
A demo of Virtify SCM is available at DIA 2013, Booth #1647, Boston, MA, June 24-26, 2013. A detailed Virtify SCM fact sheet is available at http://www.virtify.com/default/assets/File/VirtifySCM-Clinical-Structured-Content-Management.pdf
The Virtify SCM software platform is complementary to related Virtify solutions: 1) Virtify RIM:
Regulatory Information Management software to track and manage complex global regulatory data and processes. 2) Virtify CTRR: Clinical Trials Disclosure software to streamline and automate the mandatory clinical trial registration and results disclosure obligations to the National Institute of Health and other registries.
Virtify is the leading innovator in content and regulatory information management solutions for life sciences. Many of the world's leading 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 life science domain expertise has been leveraged by such companies as Genzyme/Sanofi, Novartis, Pfizer/Wyeth, Regeneron, academic research centers and CROs. Virtify's easy-to-use 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. Visit us at http://www.virtify.com
SOURCE Virtify, Inc.