Those involved in conducting multi-center clinical trials know that managing Adverse Event (AE) reports received from global trial sites can be very problematic, especially when the reports are in a different language, include handwritten notes, and are received in faint scanned and faxed format. As one clinical trial safety manager told us,
“One of the biggest pain points is that the system is too often entirely managed through email and there is always a mad rush to get all the AEs translated quickly.”
In close collaboration with our client’s clinical trial organizations, Ingenuiti developed a web-based Adverse Event document management and localization solution that meets regulatory and business requirements and ensures high translation quality. Incorporating principles of Good Clinical and Documentation Practice our team of Life Science localization experts set up standard AE report project specifications and workflows that include:
- File naming conventions
- Duplication confirmation
- Redaction of protected health information
Use of a controlled formatting template locks down document ID components and reuses source formatting to reduce cost. Based on these user requirements our in-house software team then created a web-based portal that allows global 24/7 project submission and will document all project activity, including:
- File transfer
- Project approvals
- Management of the change request process
This solution also integrates financial aspects of project management (approval of quotes, review and approval of invoices) to reduce non-essential emails and create a central repository for commercial records. In the words of a Medical Safety Program Manager who frequently uses this solution,
“The Portal is user-friendly and logically organized. Having the ability to see the various statuses of my projects along the way is helpful and the ability to add notes as a communication tool is a feature of the system that is nice, since all information for a project is stored in one central location. I wish other systems were as easy to use.”
All of these hard-wired processes and automation are only part of the story, though. The assignment of linguists specialized in clinical study documentation, trained on the therapeutic area, and specific study scope & objective are absolutely essential.
“Ingenuiti expects meticulous preparation for clinical study translations. They believe translators can only produce top quality if they are properly acquainted with all the particularities of each individual study in advance. I really appreciate this methodological approach.”
Ingenuiti’s clinical portal for Adverse Event reports has been tried, tested and continuously improved in more than 25 multi-center trials over the past 8 years. It has been audited by our clients and has passed their corporate compliance and industry data security standards. Turnaround times for translated Adverse Event reports have been reduced significantly and the portal’s audit trails have simplified client-side audits.
Use of Ingenuiti’s clinical portal for Adverse Event reporting is free of charge for our clients. Contact us today for more information and a demo.
