Oncology Dose Escalation Data Coordination
The Challenge: A client presents an ongoing first in human dose escalation oncology study with tight timeline turn around for dose escalation meetings (stop study; proceed to next dose, etc.). The client also presented a team that was shorthanded with their available time to meet these timelines and was concerned they may make errors along the way or leave important documentation out in error.
The Solution: 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 as well as to investigative sites.
The Result: With MedSource stepping in to assist with the organization of the very important data presented, to drive all of the meetings and complete all of the follow-up, there were no delays in the process and transition to each dosing cohort. In fact the MedSource Project Manager completed or exceeded the project timelines as well as transferred documentation that covered the whole process in detail for their master files. Further, the target dose was reached thus allowing the sponsor to diligently begin development of next phase studies in parallel.