A European client contracted with Medelis to conduct a phase I first-in-human study with an immunotherapy treatment in the US. The client had no operations in the US and lacked understanding of the clinical and regulatory environment for phase I oncology studies in the US.
On the client’s behalf, Medelis identified two highly credentialed and phase I-experienced sites with whom we have worked in the past. The project team was able to expedite study start-up activities and have two (2) sites open and ready to enroll the first patient cohort within eight weeks of the final protocol.
Subsequently, Medelis met weekly with the investigators to effectively manage the population of the cohorts and the phase I waiting lists at the sites. As a result, dose escalation decisions were timely and minimum delays were experienced with enrollment at new dose levels. Patient enrollment and study completion exceeded client’s timeline expectations.
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