The complexity of initiating clinical studies continues to grow. The complexity is a confluence of complicated protocols, globalization, and regulatory changes, all at a time when there is intense pressure to restrain costs and shorten timelines. The key to reducing these complexities is the ability to use machine learning to gain critical operational insights, which will allow organizations to learn and adapt. The insights gained will allow organizations to transition from subjective decisions to data-driven decisions.
In August 2021, I had the opportunity to sit down with three experts on the topic of RWE to gain a better understanding of it. In this segment, Christoph Koenen of Otsuka, Ranga Sarangarajan of BERG Health, and Gregg Sylvester of Seqirus discuss the data being collected and whether that data is clean and meets the quality standard of sponsor companies.