Be Ready for Clinical Evaluation: Making Study Data Work for You

Learn more about Capish Reflect, a software platform for exploring, analysing and visualising clinical study data, and dive into a real-world case from Lund-based Gedea Biotech, showcasing how direct access to clinical study data can support clinical evaluation and the CE-marking process.

Gedea Biotech will share how they used Capish Reflect during the clinical development and evaluation of pHyph, a vaginal tablet for the treatment of bacterial vaginosis.

The direct access to study data enabled Gedea to explore clinical trial data and visualise findings as part of the MDR clinical evaluation, including to clarify findings for the notified body reviewer during the CE-marking process.

Three Takeaways

• Understand how direct access to study data can support the medical device clinical evaluation.
• Learn from Capish how to visualize clinical study data for greater impact.
• Get a glimpse of the future: a sneak peek at Capish Reflect 2.0.

Speakers

• Eva Kelty, CEO, Capish
• Sten Kornfält, Clinical Project Manager, Gedea

Agenda

11:45: Welcoming and lunch

12:00-12:15: Introduction to Capish Reflect

12:15-12:45: Gedea Biotech case study

12:45-13:00: Q&A

13:00 Mingling with coffee

About Capish

Capish about itself: Capish is a Swedish software company specializing in the structuring, integration, exploration, and visualization of clinical and preclinical data. We provide software and services to pharmaceutical, biotech, and medtech companies, enabling direct and continuous access to data from both ongoing and completed studies.