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George Clinical takes over study management at start of Phase II as a rescue study.

SITUATION

When George Clinical was called upon to enter this Acute Myelogenous Leukemia Study in Elderly Patients at the start of Phase II, the client was dealing with a non-cooperative CRO, delays in site activation and low subject recruitment and enrollment activity. The sponsor team was also experiencing high turnover. This was a small study but required George Clinical to employ a full-service approach to the problems in order to build trust, improve communications and support a smooth transition from Phase I to Phase II.

CHALLENGES

Sponsor and George Clinical were not initially provided with documents/forms used in Phase I to support a smooth transition to Phase II. It was necessary to transition from a non-cooperative CRO who was providing no interaction with the client or with George Clinical. There were site activation delays, budget issues and insufficient subject recruitment and site engagement.