IntraLinks, a leading provider of critical information exchange solutions, announced an enhanced version of its SaaS-based Safety Document Exchange, a scalable solution for safety teams that manage reporting for Serious Adverse Events (SAEs) around the world. IntraLinks’ Safety Document Exchange enables users to save time and money related to SAE intake and subsequent safety letter distribution, while adding a layer of security and control to the process. Key enhancements delivered in the new release include configurable rules-based automated workflow, intuitive organization and user-based views, and detailed compliance reporting.
A significant number of the largest global pharmaceutical companies, biotechs, Contract Research Organizations (CROs) and Institutional Review Boards (IRBs) have turned to IntraLinks for safety document distribution. They have found that emailing, faxing and mailing safety documents is both inefficient and expensive. Utilizing IntraLinks for Safety Document Exchange, companies establish a detailed electronic audit trail and provide an easy-to-use solution to all parties involved in a global or localized clinical trial whether it’s their own staff, investigators, or study coordinators.
Using IntraLinks, safety teams can quickly receive SAE reports from sites, route them for review, and instantaneously distribute safety letters in a secure, online environment to all parties requiring notification, in an automated and trackable fashion. The enhanced Safety Document Exchange provides a simple and easy-to-use solution that eliminates paper and manual processes:
· The new workflow automation allows IntraLinks customers to establish various automatic distribution rules for Suspected Unexpected Serious Adverse Reactions (SUSARs), based on handling requirements for different regions, IRBs, CROs and other parties that require notification, which reduces cycle time and streamlines multi-part distribution.
· Users can set preferences that allow them to view only the information that is related to their interests and in the most appropriate format. For example, a sponsor team member can choose to view safety details by compound, study or region.
· On-demand reporting capabilities allow safety teams to generate real-time compliance reports that provide a record of distribution, access, and delivery failure, which includes being able to see who received the report and when they viewed it.
“Time is critical when an SAE occurs and it’s crucial that secure communication processes are in place, enabling safety teams to receive the information as soon as possible and take immediate action,” said Alison Shurell, VP, life sciences product marketing, IntraLinks. “Traditional methods of distribution are no longer practical or efficient and can have severe repercussions both for patient safety and company reputation. Our Safety Document Exchange solution helps the pharmaceutical industry to rapidly respond to SAEs and manage safety document distribution and reporting, while adhering to strict compliance regulations.”
Filed Under: Drug Discovery