Ethris Strengthening Clinical Operations With Trial Interactive

As Ethris prepared for their first clinical trials, they recognized the need for a more streamlined and future-ready approach to managing clinical recordation. Their internal processes for training and quality were entirely paper-based, with SOP training requiring in-person signatures and manual filing. This approach worked for a small team but was increasingly time-consuming, especially as more employees worked remotely.

On the clinical side, Ethris had no internal eTMF or eISF system yet, and they wanted to ensure full visibility, long-term access and proper oversight of their sponsor recordation. Prior experiences in previous companies showed the value of having a centrally managed, sponsor-owned system rather than relying solely on CRO tools.

The team wanted a platform that would support their growth, offer clarity and structure for first-time users, and give them a strong foundation for future trials.

Ethris selected Trial Interactive’s eTMF, eISF, LMS, QDMS, and TMF Services as a single, integrated environment to support both current needs and future expansion.

The decision was guided by two key considerations:

    1.  Sponsor control and oversight: Trial Interactive provided Ethris with a dedicated, sponsor-owned eTMF that ensured consistent archiving, secure access and inspection readiness, without relying entirely on CRO systems.

    2.  A fully structured electronic site file: unlike other solutions they evaluated, Trial Interactive offered a true eISF environment, not just a shared record space. The ability to move records between eTMF and eISF was especially meaningful for their long-term efficiency goals.

On the Quality and Training side, the inclusion of LMS and QDMS gave Ethris a path toward digital, centrally managed processes. The team values having a clear plan for transitioning away from paper-based activities at the right moment.

With TMF Services (Document QC, Clinical Document Lead, TMF Study Owner) supporting their current trial, Ethris benefits from expert guidance while maintaining ownership of their trial records.

With LMS, QDMS and QMS, the team moved closer to digitizing their entire clinical and operational structures.

Even as a lean biotech with much of the TMF work still handled by the CRO, Ethris has already experienced several positive outcomes:

• Simplified training and record workflows: employees can complete training electronically, from anywhere, without the need for in-person signatures or manual follow-up. This has freed up time and made training more convenient for the team.
• Better preparedness for future growth: by establishing their own eTMF and eISF early, Ethris has built a strong, compliant foundation that will support them as their clinical program expands.
• Clear potential for greater efficiency at scale: record transfer between eISF and eTMF, combined with sponsor oversight, positions Ethris to benefit even more as they move into multi-site and multi-country trials.