Article | September 7, 2022

The Keys To Success For Achieving First To File Status

Source: Worldwide Clinical Trials

Several Factors To Consider When Selecting A CRO Partner For A First To File Study

Staff Characteristics: Responsiveness and open communication is key. When selecting a CRO partner, it’s important to consider their turnover rate. Is staff turnover a pain point? Turnover in a first to file study could interrupt the study, resulting in delayed submission.

Experience: An experienced and flexible CRO is needed in order to bring all the various steps of a first to file study to successful completion. The technical capability and expertise to develop and validate methods that can perform consistently is needed to analyze a high number of samples in a minimal amount of time.

Flexibility: Since the lab must run at-the-ready, the CRO you select must have a flexible bioanalytical lab to receive, log-in, aliquot, and extract samples at any time – day or night, including holidays or weekends. The CRO’s clinical team, statistical team and medical writing team members must maintain a flexible schedule as well during this timeframe.

Quality: Does the CRO have a quality assurance (QA) team that reviews each step throughout the process to ensure nothing is amiss? While timing is of the essence, the quality of the data is equally important. Choosing a CRO that has an experienced and thorough QA team in place can help mitigate mistakes and safeguard the procedures and consistency of deliverables.

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