In pursuit of the paperless clinical trial

IntraLinks announces Adobe-based paperless solution for clinical trial process

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 NEW YORK—With the goal of making a truly paperless clinicaltrial a reality—saving pharma companies time, money and confidentialityconcerns—IntraLinks, a provider of critical information exchange solutions, hasentered into a strategic partnership with multimedia software giant AdobeSystems Inc. that will automate cross-organization data capture and submissionbased-business processes within the life sciences industry.
Under the companies' agreement, announced Nov. 4, IntraLinksand Adobe will bring to market a solution that combines IntraLinks' secure andauditable information exchange platform with Adobe's LiveCycle EnterpriseSuite, an integrated server solution that provides integrated data capture,information assurance, document output, process management and content servicesto research organizations.
The new tool provides clinical trial managers with a single,tightly-integrated platform to first conduct electronic data capture and thensecurely manage, organize and share content across firewalls with sponsors,CROs and investigative sites—effectively replacing inefficient and non-securemethods of sharing sensitive clinical trial documents such as e-mail, fax andcourier. Financial terms of the partnership were not disclosed.
Since its founding in 1997, IntraLinks has providedcompanies in the financial services industry with "virtual data rooms" or"virtual deal rooms" in which to conduct merger, acquisition and loansyndication transactions. The company's deal with Adobe marks a decade ofproviding online document exchange services to the life science industry,enabling researchers to manage access to critical and sensitive information andstreamline communication across organizations. Today, IntraLinks serves theworld's top 10 pharma companies as well as numerous biotechs, CROs and medicaldevice companies.
"We developed this platform as an online environment wherecompanies can review information in a secure and controlled manner, andpresented it to pharma companies as an opportunity to help them speed up thestudy start-up process," says Alison Shurell, vice president of life sciencesproduct marketing at IntraLinks. "The platform can be accessed 24-7, 365 days ayear, and there is a layer of auditing and reporting that enables individualsto see any activity related to the documents."
According to IntraLinks, the company has a "longstandinghistory" with Adobe, as the companies have been looking for a way to integrateIntraLinks' form exchange process with LiveCycle. Founded in December 1982,Adobe entered the consumer software market with Adobe Illustrator, avector-based drawing program for Apple Macintosh. The San Jose, Calif.-basedfirm is perhaps best known for its Illustrator, Photoshop, InDesign, AdobePageMaker and Adobe After Effects software programs.
Many life science professionals already use LiveCycle for datacapture and submission-based processes, and Adobe's partnership with IntraLinkswill give these researchers "a comprehensive solution for document-centricworkflows," said Melonie Warfel, director of worldwide standards and lifesciences for Adobe, in a statement.
"Together, Adobe and IntraLinks will work to make clinicaltrial management an efficient, paper-free process," Warfel said.
The workflow enabled by the partnership, explains ChrisThomas, senior vice president of business development for IntraLinks, is thus:Once an electronic form is created using LiveCycle ES, IntraLinks' validatedplatform manages the external workflow to organize, distribute, collect, andtrack e-forms across the firewall with email notifications and a"one-click-to-submit" process for the e-form. LiveCycle ES completes theprocess by automatically retrieving the completed forms from IntraLinks androuting them through an internal review and approval process.
"What Adobe was lacking was a compliant, validated, documentexchange platform with a mechanism to handle distribution and handling of theforms—that was something it left up to the client," Thomas says. "It wassomething that was used internally, and then a company asked the investigatorto fill out the form, which they received via e-mail, fax or courier.IntraLinks is the way to go when you want to do this with security, control andtracking. This solution increases the opportunity for pharmas and biotechs totrack information and make sure they are exchanging documents quickly and in asecure manner. In addition, for Big Pharma companies and CROs, these sites arecustomers—and they are looking for ways they can better service theircustomers. The easier you make it for your customers to fill these forms out,the more willing they will be to participate in future trials."
Above all, creating this paperless process reduces the costsand time spent on site recruitment and study start-up phases of a clinicaltrial, Shurell says.
"It's a big leap forward to accelerating this process, whichsaves costs, but more importantly, increased the opportunity to bring drugs tomarket more quickly—the Holy Grail for all pharma companies," she says. "Ittakes years to get through the whole clinical process. Meanwhile, you can hearthe time on your patent ticking away. The process starts within anorganization, goes outside and comes back in—we really want to automate thatand speed that up."

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