Orphan summarized our pharmacokinetic and safety data within 24 hours of database lock. We were then able to move our planned studies forward, while waiting for the CRO to finish the full study reports and TLFs.
CEO
They developed an enrollment monitoring and prediction tool for our project managers and monitors to use. One challenge is that our orphan disease study population is distributed around the world. However, we were still able to perform the clinical trial interim analysis and thereafter close subject screening, on time, with the help of these forecasting tools.
CMO
Orphan guided our study team on how to prepare our first eCTD and wrote the eCTD sections that our scientists and formulators were unable to write.
Investor
We needed a journal article written and submitted in advance of our major scientific meeting. We gave Orphan our data and they were able to complete it in record time.
Project Manager
FDA changed the comparative formulation analysis method used to demonstrate equivalence, and none of our CRO vendors were able to perform the calculations. Orphan developed a validated statistical analysis method, which we now use across multiple ANDAs.
