10 Agatha eTMF Questions We’re Asked During a Demo/Trial

by | Jan 25, 2022 | Blog

We get the opportunity to show our applications to customers and prospects regularly. As a result, we’ve started to see some common eTMF questions that everyone asks. So we thought we’d pull the top ten together and share them with you. You get a glimpse into Agatha’s applications – in this case, Agatha Clinical for eTMF, and we get to share some of the unique attributes of our apps.

1. Does the application use the TMF Reference Model?

Yes, Agatha Clinical uses the TMF Reference Model. For each implementation, we work with customers to determine what items in the reference model to use and what items are not relevant. We also identify any items they will need for their studies not in the reference model.  

This edited set of TMF artifacts is the starting point for the customer’s study. Each item is created as a “placeholder” document and then, as the study progresses, is replaced by the actual documents. Having placeholders and then actual items, allows the application (and customer) to easily identify “what’s missing” at any stage of the study.

2. Can I modify the standard set of documents and artifacts to reflect our specific needs?

Yes. As described above, although we always start with the reference model, we then adjust the list of expected TMF artifacts based on each customer and each study’s actual needs.

3. How does the validation process work since this is a cloud-based application?

The traditional validation model is greatly accelerated with Agatha. Because it is a cloud-based application, every customer uses the same core software, which Agatha validates through a complete validation process. Agatha’s validation scripts and records are available for inspection by any customer or their auditors.

After configuration for a specific customer, that customer then executes a set of User Acceptance Scripts that act as a final validation step, in addition to Agatha’s validation of the core functionality. That step can usually be completed in a day or less.

The result is that Agatha customers spend far less time on validation tasks than traditional platform-based systems.

4. Can site staff members add items directly to the TMF?

While site-based study team members COULD add items directly to the TMF, it is not good practice. Instead, Agatha provides a separate application called Agatha Remote ISF specifically designed to support storing, reviewing, and managing the site binder files.

Site team members upload their documents to the Agatha workspace in the cloud, where they are stored and managed. Sponsor and CRO staff members with appropriate permissions can then complete review, inspection, and monitoring tasks by accessing the stored content in Agatha. When appropriate, the items are moved to the Agatha Clinical workspace for permanent storage as part of the TMF.

5. How does the application work to support the quality review process?

Agatha Clinical includes functionality explicitly designed to support the quality review process. Reviewers or auditors can access any stored item, complete their review, indicate whether it has passed or failed, and provide comments back to the author to address any deficiencies.

Interested in a trial of Agatha Clinical? Let’s talk.

6. How do I use the application when working with CROs who use different tools?

There are a few options here. One is that the sponsor specifies to the CRO that they will use Agatha and store TMF documents within an Agatha workspace as part of their responsibilities.

In other cases, when using another system is required, the content from that system can be collected periodically and uploaded into Agatha through the Agatha import function. This import process ensures that the sponsor has the complete TMF content and therefore has the flexibility to change CROs over the course of a study if required.

7. How does training work?

The training requirement for Agatha is far less than you might have experienced with traditional applications. As part of Agatha’s onboarding process, we include all the required training for users, managers, and administrators of the application. Training can be in group sessions or one-on-one meetings. We also provide training documents and video-based training tools for ongoing reference.

8. Who manages the application? For example, who adds new users and removes them when they leave the study?

Typically, a member of the customer’s team becomes the application manager and manages tasks like adding and removing users. The Agatha team is always available to assist, however. In some cases, a customer may ask Agatha to act as the administrator and manager of the application — this is called “managed services.”

9. How long does a typical implementation take? When will we be able to start using the application?

Agatha is extremely focused on speed in our implementations. We want you to be in production as quickly as possible. Many factors affect how fast you will start production use, ranging from two weeks to a few months. The main determinants of the time from start to production are the availability of the customer to review configuration activities and the degree to which the company already defines core review and approval processes. 

10. Can I easily import content into the application and retain the metadata associated with the artifacts?

Yes. Existing sets of files can be easily imported with the Agatha import function, which brings in not just the files but also the associated properties (metadata).

11. Bonus: What happens at the end of the study? What happens to the content stored within the application?

Typically, Agatha customers “freeze” the content of the TMF and prevent changes shortly after the end of a study. The information is then available on a read-only basis. At some point, the content of the study can be exported from Agatha in a structured .zip file that retains the folder structure. It can then be archived.

What else?

There you have it. Ten Eleven common etmf questions we get about Agatha Clinical during a demo or a trial kickoff. Is there anything else you’d like to know? Let us know and we’ll add it to the list.
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