A client presents an ongoing first-in-human dose escalation oncology study with a tight timeline for dose escalation meetings (stop study; proceed to next dose, etc.). The client also presented a team that was shorthanded and concerned they may make errors or leave out important documentation.
MedSource Project Management presented to (1) perform an internal review of data listings and summarize key findings for the client, (2) schedule and drive dose escalation meetings with all involved parties (sponsor, MedSource, outside medical reviewers/participants), and (3) immediately following dose escalation meetings, provide a written summary of the meeting to participants and to investigative sites.
MedSource stepped in to assist with the organization of data presented, to drive all meetings and complete all follow-up. There were no delays in the process and transition to each dosing cohort. The MedSource project manager completed or exceeded the project timelines and transferred documentation, which covered the whole process in detail, for their master files. The target dose was reached, allowing the sponsor to diligently begin development of next phase studies in parallel.