Intralinks for Remote Monitoring and Electronic Investigator Site Files (eISF)
Work better — onsite and off.
Over half of the clinical investigators working today have never conducted a clinical trial. Despite the extraordinarily high percentage of investigators who are encountering the rules and regulations for the first time, protocol complexity is increasing and trial monitors are being buried under paperwork at their desks.
Intralinks gets new investigators out of the office and into the field, where they can gain valuable hands-on experience. Investigator site files (ISFs) are stored electronically as electronic investigator site files - eISFs - and are available anytime, anywhere, on any device to authorized personnel with tightly controlled permissions. That’s part of the reason we’re the trusted solution for 12 of the 15 largest life sciences firms.
Secure file sharing provides clinical investigators with a world of ways to be more productive on site. By distributing documents electronically, filing essential and source documents in secure e-binders, supporting clinical remote monitoring (including SDV/SDR), reducing paper-driven processes and improving inspection readiness, Intralinks introduces efficiencies that save time and money in the field. Let us help you:
- Access source documents when needed, enabling faster decision making
- Reduce unscheduled visits for critical activities
- Remote review and verify source data
- Improve visit planning and follow-up
- Reduce duration and disruption of remote visits
- Provide sites with ongoing support throughout the study
- Save time, cost and delay of travel
Reduce the burden of paper with virtual Workspaces for all your site’s study-related content. Empower site staff with the tools to manage everything from regulatory binders to electronic source documents. With Intralinks, you can give clinical investigators the ability to:
- Access documents instantly, from anywhere
- Keep study documents at your fingertips for easy access
- Eliminate version control headaches
- Synchronize your desktop and integrate email seamlessly
- Maintain and demonstrate control of highly sensitive information
- Protect yourself with full disaster recovery
- Maintain compliance with 21 CFR Part 11 requirements for both open and closed systems
- Exceed HIPAA compliance requirements
Protecting patient information.
When monitors are visiting sites, it doesn’t improve their efficiency to lock them in a room whenever they need to review patient data or source documentation. Only Intralinks allows investigators to remotely review digital records under the same degree of protection without requiring redaction of patient information. To keep your clinical investigators productive on site:
- Protect sensitive documents with information rights management (IRM)
- Embed security protections at the file level to ensure they are always protected
- Break free of plugins
- Control file access throughout the life of a document, even after it has been shared
- Use Intralinks UNshare™ to instantly revoke access