If you were around the clinical trial industry in the late 2000s when Trial Interactive was born, you know the internal struggle of trying to digitize procedures. Most of us were still using Blackberrys or flip phones, and convincing management to abandon paper and move to an electronic document management system seemed daunting. Luckily, we don’t come across that struggle as often now.
Instead, we strive to simplify and modernize the processes we have in place. An interoperable, connected, and streamlined platform that can manage all aspects of a clinical trial has become mandatory. If last year showed us anything about our industry, it’s that the time to push electronic technology was five years ago. Now, we need to ensure all processes are able to run and can be accessed remotely as we make up for time lost.
The Trial Interactive 10.2 release presents another wave of technology seeking to push boundaries through machine learning (ML), artificial intelligence (AI), and making the unexpected the standard.
Transparency and clear delivery of information is critical when trying to manage clinical trial documentation. TI 10.2 Dashboards provide even more flexibility to what was already in place, including:
- eTMF Health: Show event and milestone completion with overdue documents by site, country, event, or responsibility.
- Upload: Drop files from the desktop into the dashlet with assistance to index more quickly.
- FAQ and Q&A Views
Using milestones only for managing timelines is a thing of the past. Our Events Manager is a new way to manage amendments, milestones, and any other eTMF changes that occur during the clinical trial, which provides a more comprehensive eTMF Health and Completeness View:
- Define and apply placeholders as a part of amendments, milestones, visits, etc.
- Edit sites and countries on the fly.
- Assign responsibilities and due dates to placeholders based on event completion.
- Access eTMF Health for each event to see required, missing, and overdue docs.
eTMF Reference Model
The standard set of TMF metadata is “mappable” from TI document types; however, the 10.2 system now makes this information available for better metadata exports and improved classification. For eTMF rooms, this metadata is now included with each document type in a set of virtual fields including:
- Artifact and Sub-Artifact
- Index Number
eTMF Best Practices
TI 10.2 continues to make eTMF best practices the forefront of feature and UX design inspiration:
- Causality Tracking: Track and capture the reasoning for document changes. Whether you are deactivating placeholders, moving final documents, or changing metadata of finalized documents, clear and transparent tracking is critical to ensuring a high-quality eTMF process.
- Instant Audit Trails: Auditors often ask for immediate access to a specific document’s audit trail. TI 10.2 allows users to export audit trail reporting that provides information for all documents in a room; the current list of documents in a grid; a folder, site, document type, or document ID; and documents by date.
Site activation can be held up by many process issues. Our 10.2 release looks to speed site activation through clarity and efficiency:
- An updated progress bar for essential documents shows how many documents are outstanding or require review and approval. This gives a clearer picture of how close a site is to activation.
- Study Start-Up (SSU) specialists can now preview regulatory packets in order to see if any edits are required. Users can edit these emails prior to sending them, copy any additional contacts necessary, and submit these documents by replying to the regulatory packet email, which facilitates timely receipt.
- All new sites can be added to any amendment ensuring all required documents are accounted for faster.
Trial Interactive 10.2 looks to continue many of the successes of our past releases and answer some of the requests from our users:
- An updated UX design keeps the user-friendly feel of the old TI with a more modern, document-focused view. A new card view simplifies the look of documents.
- Security is automatically assigned when providing site user access to ensure users can complete tasks required. When creating a new user, you can designate a site user along with assigning the site. This provides specific permissions based on the site template folder security configuration. A secure PIN code can be required for users to increase the security level.
Over the past few years, we’ve often discussed not what AI and ML can do, but what it can’t do. Many claims are made about AI and ML processes and capabilities, but Trial Interactive focuses on real-world applications for document ID and metadata extraction, pushing the limits of AI and ML capabilities and perfecting the things they do well, including:
- Improvements made for the extraction of all metadata, classification of the document, assignment of document type, site, contact, date, etc.
- Machine learning to aid the selection of correct site and contact defined within the eTMF room