10 MAY

Quick Feasibility for Rare Genetic Trial

 

Overview

A US Biotech company reached out to PharmaSols, to investigate the feasibility of running a trial in New Zealand on participants' stored tissue samples, where consent had been given for further research to identify a rare genetic marker.

Following a successful feasibility assessment, the sponsor decided to choose PharmaSols as their CRO partner, and after adapting their protocol, they proposed some very tight timelines. 

With our people first focus, we created important relationships that were key in keeping our sponsor's trial on track. Along with that, our unique regional position meant we had exactly what the sponsor needed to run a successful trial.

Challenges

Our team was presented with some challenges:

  • No previously published Oceania prevalence
  • No Principal Investigator
  • Needed rare participant population pool

Outcome

During the feasibility assessment, the PharmaSols team got in touch with a world-leading researcher, who had more than 200 possible target participants. This discovery led to the sponsor adapting their protocol.

PharmaSols relationship with the Principal Investigator helped with the final protocol design and ensured that relevant ethics, regulatory, and data privacy approvals were obtained. This allowed the sponsor to analyse the samples to ascertain an objective measure of the study.

The information sourced by us led to a very significant shift in trial design and ultimately led to moving the trial to New Zealand.

People are at the heart of everything we do, and maintaining essential relationships is a key part of our process. In this case, we needed to build a strong connection with the Principal Investigator to adjust the protocol. It was also because of New Zealand's diverse patient population that meant this trial could only move forward in our region.

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