How Agatha Clinical (eTMF) Helps DZS Deliver on Its Mission To Sponsors
DZS Clinical Services leverages Agatha’s eTMF application to manage the TMF for its client’s clinical trials.
DZS is a full-service Clinical Research Organization (CRO) that provides clinical research services to the pharmaceutical and device industry.
DZS is a full-service Clinical Research Organization (CRO) that provides clinical research services to the pharmaceutical and device industry. They work mostly for small to mid-sized companies and provide a full spectrum of services, including clinical development strategy, clinical operations, data analytics, regulatory and medical affairs, and pharmacovigilance and risk management.
DZS has used Agatha’s eTMF application, Agatha Clinical, for almost three years to help them manage the trial master files (TMF) for their client’s clinical trials and sees Agatha as a partner in their journey toward increased efficiency, ease, and insight into TMF management.
The Need for an Electronic Trial Master File Solution
Before adopting Agatha Clinical, DZS used various tools for managing the Trial Master File for the sponsors they serve. These tools included SharePoint, simple document repositories, and paper-based filing. Although these tools did work, they came with challenges, such as:
- Effectively sharing information for various stakeholders while ensuring the security of that information
- Managing the quality review process of the documents within the TMF
- Tracking documents to ensure the TMF was complete
“Before using Agatha, managing the TMF was a very manual and labor-intensive task.”
Greg Ambra, DZS CEO.
Managing the TMF has always been one of the services DZS offers as part of their clinical monitoring and project management services. But they were having challenges ensuring the quality of the files and managing communication and coordination between the sites, Sponsor, various functions, and senior management.
DZS knew they needed a solution to improve TMF management. They wanted something flexible, comprehensive, and affordable. And they needed a solution that worked across various geographical locations, including the EU.
According to Ambra, the decision to select Agatha was based on two factors: the system and the team.
“The system met our requirements, but beyond that, the Agatha team was very helpful and open to working with us on custom requirements and exploring solutions for some of our more specific challenges as a CRO.”
Ambra added that “the Agatha team is incredibly responsive and helpful. They are there to either resolve the issue we may be having or teach us how to do it ourselves.”
“Being able to provide our clients with access to the system (eTMF), they have recognized the benefit of having insight into the TMF at any time and ease of having shared responsibility for the TMF.”
Senior Director of Clinical Research, DZS Clinical Services
Using Agatha Clinical
As the Senior Director of Clinical Operations at DZS, Kari Brown oversees all DZS clinical projects and directs process improvement in clinical and data analytics. She shared her team’s experience working with Agatha’s eTMF application and how it has improved TMF management.
Brown said that they use Agatha eTMF for every study in which they are responsible for TMF management. It’s also the eTMF they recommend when speaking with prospective clients.
Improving Daily TMF Management
With Agatha eTMF, DZS has become much more efficient in setting up a study, adding sites and users, and uploading documents into the system. The CRAs have become more familiar with the system and the standardized manner in which documents are named and filed.
CRAs can review the TMF efficiently, which assists them with ensuring it is accurate and up-to-date with their site’s files. This, in turn, allows for an efficient site close-out at a study’s end.
“Using either the DIA reference model or client-specific templates for the TMF structure has allowed us to set up studies in the system with ease. A study can be set up in a day and sites can be added, and user permissions can be changed within minutes. The system is intuitive and easy to use.”
Ensuring TMF Document Quality Control
Ensuring document quality is another key responsibility for DZS. The CRO needed to identify documents for the quality check process more easily and then track the review process, typically performed using a spreadsheet, disconnected from the eTMF application.
Using Agatha eTMF’s built-in QC feature, DZS can perform and track quality control of each document within the system and easily report on that process.
Transparency and Shared Responsibility
Project transparency is essential for DZS and their clients. Brown said that Agatha Clinical has allowed them the opportunity to provide that transparency and help clients feel more at ease.
“Being able to provide our clients with access to the system, they have recognized the benefit of having insight into the TMF at any time and ease of having shared responsibility for the TMF.”
Supporting Remote Site Monitoring
Another area where DZS benefits from Agatha is remote monitoring, especially as travel became a challenge with the onset of Covid. Brown said they discuss the ease of use of the eTMF application with prospective clients and highlight how it can assist DZS in performing remote monitoring visits, which have become more prevalent since the start of the pandemic.
In addition, Agatha Remote ISF eliminates the need for the site to collect and retain paper copies of documents and send copies to DZS. Instead, the sponsor or CRO team can “pull” documents from Agatha Remote ISF into the Study Master File (eTMF) after they have been reviewed and approved.
Beyond Storing Documents
DZS is a leader in delivering clinical research services to life science companies. They understand and share Agatha’s vision that the new generation of clinical operations and quality software is about more than storing documents and tracking information.
Their experience and willingness to share insights and expertise have enabled identifying new requirements and opportunities that help drive innovation in Agatha eTMF and other applications.
Interested in seeing how Agatha’s applications can help you improve your clinical and quality processes? Take it for a test drive.