CHICAGO -- Structured content management solutions provider Virtify is partnering with Distributed Compliance Solutions to host Virtify solutions in secure, compliant data centers around the world. DCS, which provides controlled content management solutions based on collaboration and document platforms, has a fully validated hosting facility that is also SSAE 16, SAS-70 certified.
The Virtify portfolio includes solutions for clinical disclosure, structured product labeling, European labeling and component-based authoring and review in a validated environment. Virtify's structured content authoring approach marries data and content, the company says in an announcement. It provides authoring templates and review processes for "seamless preparation of submission-ready documents." The structured content authoring approach marries data and content in line with the quality required for global compliance.
"The old paradigm for managing documents has changed," said Satish Tadikonda, Virtify CEO, in an interview at the 47th annual DIA show. "Most companies use document management systems but not structured content."
The hosting announcement is a nice bit of dexterity on Virtify's part. The company was well positioned less than a year ago to be one of the few suppliers of solutions for PIM, the European Medicines Agency's product information management standard for product labeling in regulatory submissions. A pilot running last September was to go into production in mid-2011.
But that didn't happen, and Virtify had the pitch for its solutions swept out from under it. A decision at the EU level killed the decade-plus project just as it neared completion. The cancellation was formally attributed to a new requirement for industry that would force drugmakers to provide regulators with electronically (PDF) formatted information on all registered medicinal products by July 2012.
PIM would have provided a standard for combining structured content and electronic XML submissions. "It was Europe's first step into structured content," said Tadikonda.
Even as the EU wiped it away, regulators encouraged drugmakers to continue using internal structure standards, even with traditional Word or PDF submission formats for consistency and efficiency benefits. After all, says Tadikonda, "they still had to do the same work, so why not in a structured way?"
Some saw it as an opportunity for brand-holders to jump from the document-management diving board into the structured-content pool to create an internal central, structured-content repository for all product information, which would streamline and ensure compliance of label and literature content (including translations) and even packaging art. That's a capability beyond document management.
But despite the removal of a looming standard with global implications from its marketing pitch, Virtify (one of our 5 emerging eClinical firms to watch) maintained its development efforts, culminating in this week's solution-hosting announcement. And the company stands ready for the revival of PIM or a similar structured content standard.
- here's the release