US BIOTECH, AUSTRALIAN DEVICE TRIAL

BACKGROUND

The Sponsor, based in the United States, was interested in conducting a clinical trial in Australia to leverage the following benefits:

  • R&D tax incentive program
  • cost-effectiveness
  • accelerated timelines
  • quick regulatory pathway

As the Sponsor did not have an Australian subsidiary, M2M guided them in the choice of a local provider to set up and host an Australian subsidiary on their behalf, providing them with a local presence and to conduct their clinical trial.

CHALLENGE

Our US client had not conducted any clinical trials in Australia, so were looking for reliable local expertise.


METHODOLOGY

After assisting the Sponsor with the set-up of a local subsidiary, we leveraged our strong relationships with sites around Australia to accelerate the start-up process, achieving timely approvals and rapid patient recruitment.

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As M2M’s monitoring, medical, data management and statistics teams are all Australian based, our client was able to maximise the advantages of Australia’s R&D tax incentive program. Our highly experienced team managed this project from start to finish, completing the study two months earlier and significantly cheaper than had been projected if the study had been run in the US.

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