Pharm-Olam Insights | "Rescue CRO"
Clinical Trials are large complex projects, and occasionally a sponsor may need to make a change to bring an underperforming project back on schedule. This type of change is not taken lightly by sponsors. Making such a transition takes time and a large investment in coordination and additional money. In this post, we will take you through a general scenario for a full-service contract research organization (CRO) transition. Our example will show when a sponsor fully transitions from the CRO currently running their study to a new CRO taking over and finishing it off. You may be wondering, “how long would that take?”. After reading this article, you will have the answer based on generally accepted timetables.
Your clinical trial has been running for years potentially and now it is time to achieve a database lock that is efficient, quality driven and on time. A critical component to the overall success of any clinical trial is how Clinical Data Management (CDM) manages the trial during its conduct and how it closes it out to achieve database lock.
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