How Immune Biosolutions launched a clinical program in just three weeks with eTMF Connect and scaled from one to three studies

Immune Biosolutions moves from research roots into clinical development

Immune Biosolutions began as a biotech company focused on developing antibodies for third-party clients. When the COVID-19 pandemic emerged, the team shifted direction and began developing a novel antibody cocktail of their own, marking a rapid transition into clinical development.

That shift required more than scientific capability. It demanded operational infrastructure that could support regulated clinical trials at speed.

When rapid growth exposed the limits of SharePoint

As the team built its clinical development processes, it quickly became clear that their existing tools were not designed for regulated trial documentation.

SharePoint could store files, but it lacked the structure needed for audit trails, automated workflows, and proper document tagging. As studies grew in complexity, these gaps made it harder to maintain control over the Trial Master File and ensure consistent compliance.

The challenge was not just managing documents. It was scaling a clinical program without slowing it down.

A pivotal moment in scaling

At the point of implementation and early adoption, the team quickly saw the impact of moving to a structured eTMF system.

Searching for speed without compromising compliance

Immune Biosolutions needed an eTMF system that could be deployed quickly while still meeting regulatory expectations.

As a small and fast-moving team, they also needed something intuitive enough to adopt without heavy training overhead, both internally and with external collaborators and CROs.

‍

After evaluating options and leveraging Montrium’s educational resources, they selected eTMF Connect as their central clinical document management system.

Going live in three weeks and scaling immediately

With an accelerated onboarding approach, Immune Biosolutions successfully implemented eTMF Connect in just three weeks.

The team transitioned from fragmented file storage to a structured, compliant eTMF environment designed specifically for clinical trial documentation.

Automated workflows reduced manual filing effort, while drag-and-drop functionality and a collaborative staging area made document handling significantly more efficient across internal teams and external partners.

As adoption progressed, the organization expanded from a single study to three studies, across multiple sites and countries, without losing control of documentation quality or structure.

“I’ve always had positive feedback, even from external collaborators and CROs,” said Geneviève Bikond, Clinical Trial Assistant.

Building a more scalable and connected clinical operation

Once operational, eTMF Connect became central to how Immune Biosolutions managed clinical documentation across studies.

Teams gained clearer visibility into file structure and hierarchy, making it easier to locate and manage documents across sites and employees. Collaborative tools improved coordination between internal teams and external contributors, reducing friction in day-to-day study execution.

Quality control processes also became more streamlined thanks to improved oversight and structured workflows, reducing the time and effort required to maintain completeness and accuracy.

For a small team scaling quickly into multiple studies, the system provided both structure and flexibility at the same time.

Impact summary

By implementing eTMF Connect, Immune Biosolutions rapidly scaled its clinical operations while maintaining strong documentation control and compliance. The organization improved procedural efficiency, strengthened TMF completeness accuracy, and successfully expanded from one study to multiple concurrent clinical programs within a tightly compressed timeline.