Intralinks for Safety Document Distribution
Proactive safety reporting.
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.
Intralinks speeds response time, automates distribution and maintains detailed audit trails to improve compliance. Stay on top of reporting requirements by configuring Intralinks to:
- Leverage automatic reporting rules to adhere to country-specific regulations, site status and location and global and study-specific requirements
- Provide full audit trails, reminders and escalations
- Conduct complex and self-service reporting
- Manage delegation of acknowledgement and receipt for busy investigators
- Maintain 21 CFR Part 11 compliance
Eliminate the time and costs of staff and courier services associated with manual processing. Use our platform to:
- Distribute safety information in real time to multiple recipients
- Provide detailed track and trace
- Eliminate courier, printing and stationery charges while dramatically shrinking labor for this often manual process
Manual processes are slow and less reliable than automated ones. Intralinks allows safety teams to automate, control and manage reporting, protect unblinded information and ensure that spontaneous reports are distributed to investigator sites. Use our platform to:
- Leverage real-time distribution of safety information to increase the time available for collecting and processing adverse events
- Create instant email notifications
- Manage individual site to determine receipt of SUSARs, SESARs, PSURs and line listings