Safety Document Software manages reporting for Serious Adverse Events.

Press Release Summary:

Safety Document Exchange enables safety teams that manage reporting for Serious Adverse Events (SAEs) around world to save time related to SAE intake and subsequent safety letter distribution while adding security and control to process. SaaS-based, scalable solution offers configurable, rules-based automated workflow, user-based views, and detailed compliance reporting. Receiving, routing, and distribution are all handled in automated and trackable fashion.

Original Press Release:

IntraLinks Enhances its SaaS-Based Safety Document Exchange Solution for the Life Sciences Industry

NEW YORK -- IntraLinks, a leading provider of critical information exchange solutions, today 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 and Contact Research Organizations (CROs) have turned to IntraLinks for safety document distribution. They have found that emailing, faxing and mailing safety documents is both inefficient and expensive.

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."

IntraLinks is exhibiting at DIA's 46th Annual Meeting in Washington, D.C., from June 14 - 16. IntraLinks will be at booth number 1703.

About IntraLinks

IntraLinks is a leading global provider of Software-as-a-Service solutions for securely managing content, exchanging critical business information and collaborating within and among organizations. More than 1,000,000 professionals in industries including financial services, pharmaceutical, biotechnology, consumer, energy, industrial, legal, insurance, real estate and technology, as well as government agencies, have utilized IntraLinks' easy-to-use, cloud-based solutions. IntraLinks users can accelerate information-intensive business processes and workflows, meet regulatory and risk management requirements and collaborate with customers, partners and counterparties in a secure, auditable and compliant manner.

IntraLinks counts 800 of the Fortune 1000 as users. For more information, visit or You can also follow IntraLinks on Twitter at and Facebook at

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