Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

April 10, 2024

Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor.

The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager.

Q1. What did Stallergenes Greer have to start looking for an eTMF solution? How does Flex Databases’ solution address these challenges?

  • At any time Stallergenes should be ready for an inspection or an audit.
  • A eTMF is more efficient than a paper TMF to meet this commitment.
  • Per the demonstrations performed during the video meetings, Flex Databases’ tool seems to meet exactly our needs.

Q2. How will Flex Databases’ eTMF system impact the management and efficiency of your clinical trials?

The eTMF system will greatly increase Stellergenes inspection readiness objective.

It should also increase our CRO and vendor oversight efficacy.

Q3. Is there any feature in Flex Databases’ eTMF system that Stallergenes Greer found particularly compelling?

Flex Databases’ eTMF shares key features with its competitors but is more user friendly and enables it to run many reports.

Compared to paper TMFs, eTMFs will give the opportunity to follow and challenge our vendors.

Q4. What were the key factors to choose Flex Databases over other eTMF providers?

The main reason to choose Flex database was the customer service – dedicated project manager, library of trainings, number of accounts.

The professionalism and flexibility of the Flex Databases’ Team met during the preparation calls was also really appreciated. Besides, the cost was competitive.

Blog

December 19, 2024
Product Updates: December, 2024

We are excited to announce several new features and improvements to Flex Databases’ modules. These updates aim to streamline workflows, enhance usability, and improve overall efficiency for our users. Here’s an overview of the latest developments and their benefits. Trial Master File (TMF) Duplicates Search: Files Content Comparison Path: Trial Master File → (open project) […]

December 18, 2024
How Clinical Trial Sites Can Meet Sponsor Expectations in 2025

Clinical trials are becoming more complex every year, and sponsors are raising the bar for what they expect from sites. They want faster processes, more accurate data, and better ways to keep patients engaged – all while staying compliant with ever-evolving regulations. As we look ahead to 2025, these demands will only grow. New technologies […]

December 2, 2024
Flex Databases Achieves ISO 27001 Certification

We’re pleased to announce that Flex Databases’ IT security measures are now formally certified under ISO 27001. This certification, earned after a thorough audit, demonstrates that our systems meet internationally recognized standards for information security. ISO 27001 sets requirements for managing sensitive company and customer data securely. By achieving this milestone, we assure our clients […]

November 28, 2024
The Future of AI in TMF

The Trial Master File (TMF) is the cornerstone of clinical trial documentation, serving as the definitive record of compliance with regulatory standards and ethical guidelines. Yet, the management of TMFs has grown increasingly complex with the rise in document volume, diversity, and stringent compliance requirements. Artificial intelligence (AI) is poised to address these challenges, introducing […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.