Intralinks For Safety Document Distribution
Secure your safety document distribution.
Intralinks provides sponsors with an automated and intelligent distribution solution for delivering critical safety-related information in real time to non-regulatory stakeholders, such as investigators, institutional review boards (IRBs) and ethics committees (ECs), with actionable compliance insight for both the safety team and site monitors.
Prescription decisions have always involved a risk/benefit assessment, and in today’s crowded markets the safety profile of a therapy can be as important as its efficacy. From the moment a sponsor receives notification of a suspected unexpected serious adverse event (SUSAR), they have only 7 or 15 days (depending on severity) to collect the relevant information, review the incident, determine causality and compile and distribute the individual case safety report (ICSR) to regulatory agencies, investigator sites, IRBs and ECs involved in every active study of their drug, worldwide. This could include hundreds or even thousands of recipients.
The ability to provide monitors with read receipt reports from investigators improves site compliance, prompts delegation of responsibility and ultimately leads to increased early detection of adverse reactions before they can become serious and/or life threatening. As the industry seeks to reduce the frequency of regular onsite monitor visits through risk-based monitoring strategies, gaining this level of actionable insight is increasingly a concern for sponsors.