Case Study 2: Rapid Start – Electronic CTMS – Influenza Vaccine – Audit – Global CROThe Challenge Some studies have a very short start-up time in which to recruit dozens or even hundreds of subjects. A global CRO, on behalf of a major European pharmaceutical company, retained BELTAS to start up and monitor sites in New Zealand and Australia for an influenza vaccine study in multiple centres across the region. The recruitment period was 1 month, with intensive monitoring throughout the study. The Response 1. We undertook study training with the global CRO in Sydney. BELTAS’ CRA’s experience with the electronic Clinical Trial Management System (CTMS) system allowed for competent use for project needs and additional support for other members of the global CRO’s team. 2. A recruitment brainstorming session was undertaken with staff at the largest New Zealand site, looking at how we could attract 90 subjects in the required timeframe. After initial concerns from site personnel, 90% of subjects were recruited within the timeframe. 3. BELTAS worked closely with the global CRO to ensure that deadlines were met and all information was communicated quickly and effectively. 4. When the global CRO had short-term resource issues, we were asked to cover other sites, to ensure that the study continued to be run competently and efficiently. The Results • BELTAS was able to maintain sites to a high standard and when audited by the client there were no major or critical findings Client Feedback “We appreciated BELTAS’ flexibility in making ad hoc arrangements to accommodate the changing client requirements. Your monitor always delivered 100% quality work”
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"We appreciated BELTAS' flexibility in making ad hoc arrangements to accommodate the changing client requirements. Your monitor always delivered 100% quality work" - Client Clinical Operations Manager |
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