Getting Registries In Sync
January 27, 2010
What do life science companies produce? Medicine? Pacemakers? In truth, those items are often manufactured by anonymous subcontractors. What life science companies really do generate is intellectual property. Data. Content.
Satish Tadikonda, the founder, president and CEO of Virtify, says that the content in our regulated industry will increasingly be required to adhere to a variety of standards for clinical data, structured product labels and other standardization regimens. "We are focusing on enterprise content. A number of standards are coming into place," he says. "They're getting interlinked. They are global."
The sheer number and interlocking complexity of those standards, Tadikonda says, are reaching beyond drugs, biotech products and medical devices. The standards are touching animal health, cosmetics, neutraceuticals. The alphabet soup of current or future standards is a bit overwhelming at first, especially when the sponsoring organizations like the World Health Organization (WHO) and FDA don't always have clearly articulated road maps for harmonizing all of the acronyms.
For global firms of any size, that raises the question of adhering not just to one or two standards, in one or two geographic regions, but across different regulatory environments and product release time tables. "The breadth of these activities is starting to bring in an angle around e-compliance," says Tadikonda. "The next logical step is: how are the business process support functions going to manage this data?"
While the industry's predilection, until now, has been to have vital data carefully sprinkled across separate systems, or even individual employees' Excel spreadsheets and Word documents, that is not always an efficient or sound approach. Why? What if your regulatory affairs system doesn't tell senior managers that document number 45129-&A-BAY on someone's hard drive was updated? What if the French government receives that document but medical journal editors in Japan do not?
Some companies still believe that individual files or manually set reminders can help individuals stay on top of such details. In the past, the industry handled snippets of data one file at a time, one folder at a time, with little thought to reusing the underlying content. After all, passing the information to more than one other entity, even inside the same company, was not always easy or permissible.
Virtify, for the record, doesn't require that file-based IT approaches, however cumbersome, be tossed into the virtual recycling bin. Its system will run next to Documentum or the Microsoft SharePoint collaboration environment. Those systems work, up to a point, but neither are deeply versed in all the nuances of the life sciences and 21 CFR Part 11. "We are infrastructure-neutral," says Tadikonda. "If companies have invested in Documentum or some other system, we can talk to those systems in a bidirectional manner. Companies don't have to throw that existing investment away."
Multiple Content Types
His customers, he says, are often looking for a more comprehensive approach. They would rather reuse critical bits of content from documents, submissions, trials and labels, separating the data from its formatting, destination and delivery medium. That allows real management and control of the content. Which is bordering on a novel philosophy for some firms that have been improvising about how to handle clinical research content until now.
"These are like neurons and interlinked," Tadikonda says of discrete elements of research-related content. "The game is moving to how they are interlinked." You can see a list of the types of functions Virtify can help with here. At a basic level, he's talking about clinical data, structured product drug labels, even data inside systems for electronic medical records. Everything from preclinical to postmarketing.
Helping with electronic common technical document (eCTD) publications and electronic file management is territory that firms like Mission3 and Octagon Research have also explored. Virtify's vision is a bit broader. The firm is based in Cambridge, Mass., with offices in India, Bulgaria and the Phillippines.
Virtify is pointing customers toward a more unified data environment prior to all of the regulations and standards creating conflicts or incidents of an embarassing sort. If a filing deadline is missed, or a label garbled, the reputational cost could be significant. "You need to have a plan to get between now and all the upcoming rules," Tadikonda says. "You need to think about it and take it on with some sense of urgency in a few areas, but not making the mistake of going for point solutions."
One new-ish task that the Virtify platform supports is quite manual and time-consuming, even for small firms. How to simultaneously update trial records on government trial registries for clinicaltrials.gov, not to mention at the WHO and a few U.S. states that have their own quirky mandates?
Depositing not only active trials but results into government registries is not discretionary. Even at small companies, Tadikonda suggests, serious technology is needed to manage such updating, and to be sure that a company's global dissemination of trial-related plans and results is always accurate and timely. Tadikonda can't point to a specific public relations debacle yet. But he anticipates that if there are gaps or discrepancies between what a company is telling regulators, the media and the scientific community, there are potentially negative implications for a company's reputation.
He goes on to say that the challenges to updating registries like clinical trials.gov are more complex than they may appear at first. One reason is that the U.S. database accepts XML data in an automated fashion, while some WHO databases do not. Also, different registries may request exactly the same information that has been submitted to another registry, but phrase their requests with subtle differences. And the rules for how and what to put in registries change frequently, if not capriciously.
"The pressures for a lot of companies are racheting," says Tadikonda. "Companies are becoming aware of the potential implications down the road. How do you make the same content linked to other content so that if the parent changes, the other content changes? We have a tool which allows you to address this problem in three or four aspects. It allows you to automate the whole process."d9A2t49mkex