22 JULY

Rapid start-up: First SIV in less than 35 days

Overview
Faced with a challenging recruitment process, needing to recruit a large number of elderly participants within a tight three-month seasonal recruitment window, a US-based Biotech Company appointed PharmaSols as the NZ CRO for this phase three respiratory clinical trial.

Having previously worked with PharmaSols over a number of trials, the US sponsor knew that the PharmaSols team could deliver on both tight start-up timelines and high recruitment targets. PharmaSols proven record of flexible, rapid, and creative solutions meant we were the ideal CRO partner.

Understanding New Zealand’s centralised ethics and regulatory bodies' processes and timelines, PharmaSols swiftly obtained the necessary Ethics and Regulatory approvals prior to the first site initiation visit (SIV). These short start-up timelines gave us a competitive advantage in recruiting significantly more participants than our global CRO partner across the same number of trial sites.

Challenges
There were several challenges while supporting this study:
• Tight timelines
• Needing to obtain ethics and regulatory approval quickly
• Recruiting a large number of research participants in a short period
• Engaging an elderly population to participate in a research trial

Using established site relationships for successful recruitment

Taking advantage of New Zealand’s diverse participant population, we engaged with trial sites with proven histories of high patient recruitment. We worked closely with these sites to develop successful strategies that recruited over 600 patients within our short three-month timeframe.
We assigned to the trial an experienced team and ensured there was a higher ratio of CRAs to support the trial sites. In keeping with our people-driven approach, we prioritised the sites' needs to maintain patient retention. This meant that part of our criteria for CRA selection was that they needed to be based near the sites, allowing them to respond rapidly to any problems and assist with high recruitment and peaks in monitoring activities.

Outcome

Our innovative approach to challenges like these enabled us to meet our client’s deadline efficiently. PharmaSols obtained the first SIV in less than 35 days and recruited almost twice as many patients as our global CRO partner over the 3 month recruitment period.