US BIOTECH, INTERNATIONAL TRIAL
BACKGROUND
A CRO based in the United Kingdom, acting on behalf of a US Biotech company, was interested in including Australia as part of a large Phase III oncology clinical trial due to the following benefits:
- key opinion leader expertise
- incidence of targeted disease
- recognised high quality data
- regional project management expertise
CHALLENGE
The UK CRO and US sponsor had also included South Korea, Japan and Taiwan as participating countries but due to language, cultural, regulatory and time differences the communication with the Southeast Asian countries was impacting on the trial.
METHODOLOGY
We assisted the UK CRO and Sponsor by offering regional project management services and operating as a link between the global project manager and the Southeast Asian countries whilst continuing to project and site manage the Australian arm.
Our ability to establish excellent working relationships across the Australia and Southeast Asian countries ensured a more cohesive team built on respect, trust and clear communication.
The UK and US team were able to better understand and appreciate the regional regulatory requirements as the communication barriers improved.
Communication improved because meetings were able to be conducted within local time zones.
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