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Flexible Workflows Make the Tightest Turnaround Times Possible
Given the relatively streamlined regulatory process for phase I projects in Australia, Novotech was recently presented a challenge by a US west coast biotechnology firm to coordinate and manage a full service phase 1 study involving multiple cohorts, a dose escalation regimen, and a locally convened Drug Safety Monitoring Board (DSMB).
We were required to hold DSMB meetings within 24 hours of subject completion in each cohort to allow seamless escalation to the following dosing cohort. This presented a particular challenge for the Data Management team given the <24 hour turnaround time available between last subject in each cohort and the subsequent DSMB meeting. A small biometrics team was quickly dedicated to this project, and a flexible workflow schema designed involving the research team at the site, Novotech data management and clinical monitoring teams, overseen by project management. Dedicated fax lines were put in place for transmission of CRF pages to Novotech DM as close to real time as possible upon completion of CRF data on site. Monitoring staff were placed on a rotating on-call schedule to resolve any major queries with same-day turnaround, and live updates provided to client headquarters in California twice a day. The Data Management team was able to meet these tight turnaround times for each of five cohorts in the protocol, and was on hand at each DSMB meeting to ensure database related questions could be clarified on the spot.
In the event, no database clarifications were required, the entire study progressed through full enrolment in less than four weeks with final study database lock occurring two weeks after the last cohort was dosed. The follow-up study to this milestone project was thus able to be started a full two months ahead of schedule.
After all, there is no substitute for experience. |
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