Since implementing eTMF Connect at the beginning of 2022, the Immune Biosolutions team has leveraged the platform to expand their clinical development pipeline to three studies.
Diving head-first into a new challenge
Immune Biosolutions got its start in the biotech industry by developing antibodies for third parties. When the COVID-19 pandemic hit, they felt compelled to leap into action and use their know-how to combat the virus through the creation of a novel antibody cocktail. Once they got to work building a clinical development process for their game-changing therapeutic, they quickly realized the need for an agile eTMF system that could keep up with the rapid growth of their organization.
Adapting to meet evolving objectives
As the Immune Biosolutions team got to work establishing their processes for clinical development, they quickly realized that they would need an eTMF system in place capable of providing the features they were missing in SharePoint, including automated workflows, audit trails, and tagging. After leveraging Montrium’s online educational material to build out a basic repository, Immune Biosolutions realized that they had found the credible and competent provider they were looking for. They were thrilled that Montrium was able to commit to meeting the tight implementation timeline they had set to adapt to the swiftly growing needs of the study.
Magali Lurquin
Empowering efficient study management
Immune Biosolutions recognized that they would need to find a powerful, easy-to-use eTMF system that they could get up and running as quickly as possible. With tight timelines, it was critical that the Immune Biosolutions team found a system that could be implemented quickly but didn't compromise on functionality. “We needed to start implementation and go live within three weeks, and it happened. The Montrium team mobilized quickly and designed an accelerated onboarding. That was really great,” stated Magali Lurquin, Senior Associate, Regulatory Affairs at Immune Biosolutions.
As a smaller team, Immune Biosolutions was pleased to discover how easy the system is to navigate and use. “Even from the external collaborators and CROs we have, I’ve always had positive feedback,” stated Genevieve Bikond, Clinical Trial Assistant at Immune Biosolutions. Since implementing eTMF Connect, the team has been able to leverage powerful features like automated workflows, drag-and-drop filing, and a collaborative staging area to expand their clinical development process across multiple studies, sites, and countries. “I have been asking myself how it would be possible to do what we’re doing now with our old SharePoint site or with paper. The reality is, the eTMF Connect system made it feasible in a more efficient and quicker way,” added Genevieve Bikond.
• Montrium’s dedicated Customer Experience team helped Immune Biosolutions to implement eTMF Connect within three weeks.
• Comprehensive training recordings and in-system Q&A chat have allowed Immune Biosolutions employees to quickly find crucial information without needing to submit support tickets.
• Features like collaborative authoring and a dedicated staging area have enabled Immune Biosolutions to easily manage communication with both internal and external contributors.
• The Immune Biosolutions team has noticed a significant improvement in all areas of compliance, most notably in completeness accuracy and overall efficiency.
• eTMF Connect’s easy-to-use interface has saved employees time and energy by empowering external collaborators to quickly understand how to use the system without extensive training.
• With eTMF Connect, Immune Biosolutions has gained improved visibility into the hierarchical organization of their files, making it easier to access all documents for specific employees or sites.
•Better and more holistic oversight has allowed Immune Biosolutions to streamline the QC process.
increase in procedural efficiency
improvement in completeness accuracy
improvement in timeliness
The ability to automate historically tedious TMF filing activities, freeing up time in the workday.
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