Sonova, a global leader in hearing solutions, was challenged by legacy systems, a paper-based TMF, electronic folders and documents in an eQMS, which limited their clinical trial process. Sonova developed a comprehensive change management strategy and implemented Veeva eTMF to realize their compliant by design vision.
The initial goal of their transformation is to move away from fragmented, paper-based solutions in favor of a unified eTMF supported by stronger governance, process improvements, and a newly defined clinical operations team.
Dian Liu, clinical affairs manager at Sonova, laid out a multi-faceted strategy to simultaneously introduce new technology and leverage a restructured organization to achieve operational excellence, inspection readiness, and ensure robust clinical evidence.
Previously, Sonova maintained an essential study document list with 82 items. The document list required extensive manual effort to maintain and minimal governance made it difficult to retrieve data from older studies.
To maintain rapid product launch timelines, they had to prioritize speed over more detailed documentation to allow new products going to market with a minimal amount of confirmatory pre-market studies.
By implementing Veeva eTMF and streamlining processes, Sonova improved documentation practices. As a result, they were able to fully replace the manual document list, manage their study portfolio globally, and introduce stricter document review and approval processes for all studies.
Liu said, “Implementing a standardized eTMF helped us drive compliance to the next level. But, we needed to create clear parameters, as well as role-based and study-based access to enable our study managers to run more efficient studies.”
It was important to establish a baseline and preconfigure the system to Sonova’s needs, as well as clearly define who has access to which studies, and which study documentation is available within individual studies.
Study managers are required to proactively address and justify any document exclusions. These measures significantly increased the level of transparency in terms of user and document management.
In addition to introducing Veeva eTMF, Sonova established a dedicated clinical operations team to enable audiological researchers to streamline trial activities.
Liu realized the value of dedicated operations personnel, “We introduced the clinical operations role to support the study managers with project management, TMF administration, and coordinating other stakeholders. We involved them on the core team to build local confidence and expertise that can then spread further across the organization.” Clinical operations was critical in up-leveling the skillsets of the audiological researchers.
In addition to introducing the clinical operations team to their existing infrastructure, Sonova developed a comprehensive training program to ensure adoption and efficacy of its new processes and Veeva eTMF.
Sonova was diligent in keeping training digestible and consistent to avoid information overload and allow team members to engage with the appropriate training for their role.
The goal of the training was to establish a common language rather than covering all functionalities of the eTMF in detail. The modules focused on practical, hands-on application and were broken down based on level of study involvement:
Sonova created a comprehensive governance model to ensure that training and processes are being followed and easily improved upon by the clinical teams.
Liu says, “Governance is solidified through monthly core team meetings where a personalized dashboard is reviewed within Veeva eTMF. This dashboard tracks key metrics like completeness, timeliness, and the number of open quality issues.”
This oversight and transparency helps Sonova address specific issues, identify and alleviate confusion, and implement ongoing improvements to trial activities and processes based on tangible data and study manager feedback.
The combination of technology, education, and governance has helped maintain compliance and make data-driven decisions.
Liu shared four key lessons to help other medtechs achieve operational excellence, inspection readiness, and a robust clinical evidence strategy:
Sonova has successfully embarked on their compliant by design vision by establishing core pillars in education, governance, and technology. This foundation has enabled them to enhance reporting capabilities, maintain inspection readiness, and drive clinical excellence.
Going forward, they remain focused on improving system capabilities and processes to develop a more robust clinical evidence generation strategy and forward-looking success metrics.
For similar learnings, read how Axogen ended manual QC and stays inspection ready with the Veeva Clinical Platform.