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.