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In pursuit of the paperless clinical trial
NEW YORK—With the goal of making a truly paperless clinical trial a reality—saving pharma companies time, money and confidentiality concerns—IntraLinks, a provider of critical information exchange solutions, has entered into a strategic partnership with multimedia software giant Adobe Systems Inc. that will automate cross-organization data capture and submission based-business processes within the life sciences industry.
Under the companies' agreement, announced Nov. 4, IntraLinks and Adobe will bring to market a solution that combines IntraLinks' secure and auditable information exchange platform with Adobe's LiveCycle Enterprise Suite, an integrated server solution that provides integrated data capture, information assurance, document output, process management and content services to research organizations.
The new tool provides clinical trial managers with a single, tightly-integrated platform to first conduct electronic data capture and then securely manage, organize and share content across firewalls with sponsors, CROs and investigative sites—effectively replacing inefficient and non-secure methods of sharing sensitive clinical trial documents such as e-mail, fax and courier. Financial terms of the partnership were not disclosed.
Since its founding in 1997, IntraLinks has provided companies in the financial services industry with "virtual data rooms" or "virtual deal rooms" in which to conduct merger, acquisition and loan syndication transactions. The company's deal with Adobe marks a decade of providing online document exchange services to the life science industry, enabling researchers to manage access to critical and sensitive information and streamline communication across organizations. Today, IntraLinks serves the world's top 10 pharma companies as well as numerous biotechs, CROs and medical device companies.
"We developed this platform as an online environment where companies can review information in a secure and controlled manner, and presented it to pharma companies as an opportunity to help them speed up the study start-up process," says Alison Shurell, vice president of life sciences product marketing at IntraLinks. "The platform can be accessed 24-7, 365 days a year, and there is a layer of auditing and reporting that enables individuals to see any activity related to the documents."
According to IntraLinks, the company has a "longstanding history" with Adobe, as the companies have been looking for a way to integrate IntraLinks' form exchange process with LiveCycle. Founded in December 1982, Adobe entered the consumer software market with Adobe Illustrator, a vector-based drawing program for Apple Macintosh. The San Jose, Calif.-based firm is perhaps best known for its Illustrator, Photoshop, InDesign, Adobe PageMaker and Adobe After Effects software programs.
Many life science professionals already use LiveCycle for data capture and submission-based processes, and Adobe's partnership with IntraLinks will give these researchers "a comprehensive solution for document-centric workflows," said Melonie Warfel, director of worldwide standards and life sciences for Adobe, in a statement.
"Together, Adobe and IntraLinks will work to make clinical trial management an efficient, paper-free process," Warfel said.
The workflow enabled by the partnership, explains Chris Thomas, senior vice president of business development for IntraLinks, is thus: Once an electronic form is created using LiveCycle ES, IntraLinks' validated platform manages the external workflow to organize, distribute, collect, and track e-forms across the firewall with email notifications and a "one-click-to-submit" process for the e-form. LiveCycle ES completes the process by automatically retrieving the completed forms from IntraLinks and routing them through an internal review and approval process.
"What Adobe was lacking was a compliant, validated, document exchange platform with a mechanism to handle distribution and handling of the forms—that was something it left up to the client," Thomas says. "It was something that was used internally, and then a company asked the investigator to 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 and tracking. This solution increases the opportunity for pharmas and biotechs to track information and make sure they are exchanging documents quickly and in a secure manner. In addition, for Big Pharma companies and CROs, these sites are customers—and they are looking for ways they can better service their customers. 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 costs and time spent on site recruitment and study start-up phases of a clinical trial, Shurell says.
"It's a big leap forward to accelerating this process, which saves costs, but more importantly, increased the opportunity to bring drugs to market more quickly—the Holy Grail for all pharma companies," she says. "It takes years to get through the whole clinical process. Meanwhile, you can hear the time on your patent ticking away. The process starts within an organization, goes outside and comes back in—we really want to automate that and speed that up."