In the ever-evolving world of medical technology, Optos stands out as a global leader. Their journey, particularly in the realm of clinical trials, is a testament to innovation and efficiency. This post delves into an insightful conversation with Giulia Bignami, Clinical Trial Manager at Optos, exploring their collaboration with Agatha, a provider of electronic Trial Master File (eTMF) systems.
Optos and Agatha: A Partnership for Progress
Giulia Bignami, who has been with Optos since its adoption of Agatha’s eTMF system in 2019, sheds light on the pivotal role Agatha played in transforming Optos’ clinical trial documentation process. Optos, known for its patient-friendly devices capturing ultra-wide-field images of the retina, required a system that could match its global reach and innovative ethos.
Key Requirements and Solutions:
Optos’ primary need was a cloud-based system to facilitate access across its widespread teams in the UK and the US. Agatha’s customizable filing structure, tailored to meet the unique needs of a medical device company rather than a pharmaceutical one, was a significant factor in their choice. This flexibility and accessibility have been crucial in managing both pre-market and post-market clinical trials globally.
Conclusion:
The collaboration between Optos and Agatha highlights the importance of adaptable, efficient systems in the fast-paced world of medical device development. Their journey is a beacon for companies seeking to streamline their clinical operations while maintaining global connectivity and innovation.
Interested in seeing how Agatha’s applications can help you improve your clinical and quality processes? Take it for a test drive.