¾ÅÉ«

Within the past few years, the conversation has shifted from deciding between paper or electronic TMF solutions to instead solidifying what features are required to make an eTMF solution the most optimal. Technology is evolving¡ªand while the life sciences industry has a reputation for being slow to adopt tech advancements in clinical research, it¡¯s catching on to innovations in eTMF pretty quickly.

With the rising popularity of cloud-based solutions for product development, submission, and commercialization support, Trial Interactive 9.0 helps stakeholders align the capabilities of multiple modules and tools, maximizing ease of use and allowing users to effectively plan, track, store, and deliver required documentation.

As always, ¾ÅÉ« is driven by the overarching mission of achieving better clinical trial efficiency and ¡°TransParency¡± for our customers and the industry. Trial Interactive, our e-clinical platform, not only offers a broad suite of e-clinical modules, but also best-in-class functionality, advanced collaboration features, and complete scalability to function as a dynamic, intuitive, and powerful solution¡ªproviding unparalleled customer benefits and value across the clinical development landscape.

Our suite of solutions includes:

Here are nine new features in our latest version, Trial Interactive 9.0, that have put our users on, well, Cloud Nine:

New and Improved User Interface (UI)

An elevated user experience is essential for any software platform to increase adoption rates and visibility. In this version of Trial Interactive, we focused on human-centered design with improvements that bring greater consistency to the iconography, window panes, and user controls¡ªgiving our users an enhanced, modernized, and simplified experience across all modules.

Changes to layouts, optimized search bars, and redesigned notification panels improve navigation for users¡ªthose who are utilizing the eTMF and Study Start Up modules can search optimally across various sections, making it easy to see subsets and documents quickly and intuitively.

Along with robust access controls, we have enhanced security by partnering with Seclore, a digital rights management (DRM) tool. DRM ensures that study information is only shared with authorized personnel by providing controls for viewing, saving, and printing.

Active eTMF Completeness View

To achieve true TMF completeness, it is necessary for the system to not just simply identify a particular document type as missing, but to granularly identify which version of a document or monitoring-visit-related document type is missing.

This can be achieved by utilizing site/study/country milestones, which are pre-existing features of TI eTMF. However, for this to work, all study events and milestones would need to be tracked in TI eTMF so it can accurately report on expected vs. received documents. While that is ideal, the reality is that different study teams track study events and milestones in various locations, such as Excel trackers or CTMS. Not tracking all events in TI eTMF, therefore, introduces "gaps" of documents being identified as missing during various manual quality reviews. These gaps are now typically being maintained in external trackers by our client teams, which defeats one of the main purposes of our system: to do all tracking within the platform! Why use an outdated tracker when you can do it all in Trial Interactive?

Trial Interactive 9.0 allows the users to create placeholders (for required documents) from anywhere in the system (dashboard, documents, etc.) with a click of a button.

Created to easily accommodate the ¡°gap analysis¡± reviews for a study or project, this feature enables you to closely track your eTMF completeness in real time by viewing all documents that are missing, available, or expected in one place. If the study or project is missing a document, the system auto-creates a placeholder or the user can create a placeholder¡ªthen tag the correct type of document, fill in accurate metadata, and plug in the gaps that might have otherwise yielded deficiencies in your eTMF.

Once the document is available, upload it to the placeholder and all the relevant metadata will be applied automatically. Users can also view and track eTMF completeness using our various dashlets, giving a real-time, visual status of the eTMF health.

Agency Submission Package Management

Sites located in the European Union (EU) usually have more complex site activation submission requirements than sites in other countries. These requirements often include additional submission package documents, which are not relevant to the TMF, but need to be submitted to different (potentially multiple) regulatory agencies in addition to the Institutional Review Boards (IRBs) or Ethics Committees (ECs).

Trial Interactive 9.0. allows users to easily manage submission packages within the system. Utilize documents that are already stored in your eTMF and/or upload additional documents from your desktop or network drive. Use of the Trial Interactive Shared Workspace can further reduce the use of desktop and network drives.

Capture Outgoing E-mail Communication

When there is email communication between clinical trial staff (including teams, regulatory bodies, investigative sites, and even IRBs/ECs), there¡¯s always the risk that a particular correspondence may not get filed in the eTMF. To ensure eTMF completeness, version 9.0 introduces the ability to auto-file outgoing email chains. When sending out emails from the system, users can simply choose the option to file the correspondence and tag a document type.

Manage, Track, and Streamline Audits and Inspections

There is no question that eTMF technology has greatly improved inspection readiness. But what if we could streamline and simplify the process even further? Version 9.0 has addressed the biggest pain point when it comes to audits and inspections: tracking documents sent for review. Now, when an auditor encounters a document issue, they can notify the submitter via a query. These queries are sent out via email and fully tracked within the system.

LMS - Track and Train!

While SOP learning is crucial, users tend to avoid it like the plague. TI 9.0 improves the experience by integrating our eTMF with the LMS module. Users no longer need to switch back and forth between applications for their training and can easily track their progress using visual dashlets.

Dynamic Reporting and KPIs

In the past, Excel trackers and other manual tools were often used to track receipt of documentation or TMF completeness, increasing the risk of discrepancies or errors. With our integrated reporting tool, users can collect, organize, and present data in visual KPI dashboards. These dashboards consolidate and arrange reports and performance data on a single screen.

Robust Integrations

Trial Interactive eTMF and Study Start Up modules now integrate with Chesapeake IRB, Schulman IRB, and other partners to streamline global trial management for sponsors and CROs.

Electronic and Digital Signature

21 CFR Part 11 is synonymous with compliance in the Life Sciences industry. Sponsors and CROs need to be able to demonstrate that their TMF workflows are meeting the necessary regulatory requirements for electronic records.

Any electronic or digital signature technology used in an eTMF also needs to meet the requirements of 21 CFR Part 11. Trial Interactive fully complies with regulatory requirements, can provide this information through electronic logs and audit trails, removing the need for signatures on every document.
 

While the above features provide a lot of value in streamlining your clinical trials, there is a lot more! Please reach out to us at info@trialinteractive.com for a demo so we can give you a full overview of the technology we are so proud of.