AUSTRALIAN BIOTECH, INTERNATIONAL TRIAL

BACKGROUND

The sponsor, a Melbourne based Australian biotech company were seeking support for their phase IIa clinical trial. As they had minimal in-house capacity, they required:

  • full clinical operations support
  • data management and statistics
  • medical monitoring and
  • medical writing
CHALLENGE

Upon review of the protocol, it was determined that specialist sites in the UK would be required to enable us to gather the complex pain data required.


METHODOLOGY

M2M liaised with our international colleagues to identify appropriate sites who could contribute the required patients and data. By leveraging our AICROS network, incorporating UK and German services, we were able to identify the appropriate expertise in the UK and open three sites.

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M2M successfully managed Australian and UK sites to be able to provide the necessary data to ensure the study endpoints were met.

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