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.