Using real-world evidence to expedite regulatory approval

It is essential for biopharmaceutical companies to provide authoritative evidence to prove that their product delivers superior clinical outcomes and demonstrates value. Using RWE to expedite regulatory approval has become increasingly common, but success for those submissions remains anything but certain.

See how experts from our Real-World Evidence and Insights team helped a biopharmaceutical company generate a RWE control arm to supplement phase 2 experimental data. Through these efforts, the company was able to successfully secure FDA accelerated approval and a competitive market entrance.