Compassionate use programs provide access to investigational products on unsolicited physician requests for patients with serious or immediately life-threatening conditions. These patients either have limited treatment options or have exhausted all other standard therapies.
Late Phase Research/Real World Data
The convergence of payer and regulator evidence requirements warrants a strategic evidence generation plan and a mindful orchestration of peri and postapproval real-world studies. Study designs resulting in a diverse array of health economic and safety data are increasingly warranted to meet the demands of various stakeholders.
Recently we announced the expansion of our Risk Management Services in Europe. Janine Collins, M.D., has joined UBC and is leading our European Risk Management activities and Medical Safety. As we knew she would, she’s hit the ground running. Dr. Collins is attending the 25th Annual DIA EuroMeeting early this week and she’ll be presenting later this week at Late Phase Research/Real World Data.