Safety Document Exchange

Your Suspected Unexpected Serious Adverse Reaction (SUSAR) Notification process should be painless.

At a time when pharmaceutical companies and CROs are under intense scrutiny, delays in Serious Adverse Event (SAE) reporting can have severe repercussions both for patient safety and company reputation.

Challenges & Opportunities
Your investigative sites are increasing in number and going global. The scope and complexity of distribution grows. Managing SAEs is now more labor-intensive, costly and complex. In certain cases, your safety team scrambles to meet tight deadlines surrounding safety document distribution. Without an efficient platform for communication and report distribution, your safety team lacks the control and agility to effectively manage the production, distribution and overall cost of their SAE documents.

Products & Services That Can Help
IntraLinks for Safety Document Exchange ensures a secure, efficient and scalable environment where safety teams can receive SAE information. And, upon determining this event is reportable, immediately and simultaneously distribute safety letters to all parties who need to be notified. The results? Less time, money and human resources spent on safety document distribution. More time for fact finding and report writing. More accurate and complete information is available to all parties.

• IntraLinks Exchanges provides a secure, controlled environment that allows you to establish an efficient and repeatable process for safety document receipt and distribution.
• IntraLinks Connectors to leading safety systems enable SAE reports to be seamlessly routed for internal review and formal report preparation.
• IntraLinks Exchanges provides real-time reports to maintain records of report distribution, recipient delivery status, document access and timing to improve audit-compliance for regulatory requirements.