FDA advisory Panel

Posted on 19 June 2019

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FDA advisory Panel

From March 2019 until now Lyncoclinical was asked to support preparation work for a safety panel meeting called by the FDA.

Such panel meetings are extremely rare so participating in the preparation was perceived as an exiting time for me! Our assignment was to work out a strategy to obtain crucial data from patients lost to follow up in studies done with the product under review. Next to setting this strategy with management, legal and GDPR specialist I worked with a small team of 3 colleagues to also set up a database, contact sites and Ethical committee's to obtain this data.  

With only having 4 weeks to fulfill this task, obtaining data from almost 300 patients, distributed over 44 sites in over 25 countries we were challenged yet succeeded in this task with obtaining 98% of the data. 

The sponsor expressed to be proud of our team and how we showed up as industry leaders. On several occasions we were uniquely called out by the FDA for our collection of data and the rigor of its clinical analyses. The preparation of our team was unmatched and recognized throughout the two-days.

There is still a lot of work to do, but this was an incredibly important milestone. 

Words from our Vice President:

"I want to express my gratitude not only to the team who dedicated several months of effort, including weekends, to address the questions around our device, but also to my entire organization.  You are all a testament to resilience and flexibility and I am so honored at how everyone contributed to our preparation for this panel. While some were hyper focused on the FDA panel and questions, the rest of you continued to perform and deliver results while also stepping up to fill any gaps and ensure nothing was missed."