01 Dec

Rapid Study Startup and High Patient Recruitment for US Biotech Clinical Trial

Overview

A US-based biotech company was seeking a CRO who could successfully recruit a large number of elderly patients in New Zealand. A challenge squeezed into a three-month recruitment window. 

With our track record of making the difficult looking easy, they chose Pharmaceutical Solutions (PSL) as their New Zealand CRO partner. 

Our centralised and efficient Ethics and Regulatory bodies in New Zealand enabled us to swiftly obtain  the necessary approvals prior to the first Site Initiation Visit (SIV). These short start up timelines gave us the competitive advantage in recruiting significantly more patients compared to our global CRO partner – utilising the same number of trial sites. 

Challenges

There were a number of challenges while supporting this study:

• Tight timelines and the challenges of getting ethics and regulatory approval quickly
• Rapidly identifying a sufficient number of experienced trial sites to meet recruitment targets
• Recruiting a large number of patients in a short period
• Engaging an elderly population to participate in a research trial
• Technology challenges in working with an elderly population while collecting daily diary information via iPads

Our Approach

The driving force behind our success is our dedicated people-focused approach.

Straight away, we established an experienced team and used a higher ratio of CRAs to support our selected trial sites. 
Along with their expertise, we selected CRAs located near our sites – allowing them to respond rapidly to any problems, as well as assist with high recruitment and peaks in monitoring activities. 

Having fostered strong relationships with the site staff over many years, our CRAs could support them through any issues that arose with technology, working with an elderly population, and keeping them motivated to recruit.

The Outcome

By obtaining ethics and regulatory approval and the first SIV in less than 35 days, as well as recruiting almost twice as many patients as our global CRO partner, we easily met the client’s deadline.

When faced with critical data not transmitting from patient iPads, PSL facilitated urgent meetings with the technology provider to resolve the issue quickly and keep the trial on track.

The end result was a successful clinical trial and very happy sponsor. 

“We have chosen to do many of our clinical trials in New Zealand because the quality of the Investigators, site staff, and clinical research organisations (PSL) is very high, and they have a wonderful  ‘can-do’ attitude which is really important for getting clinical trials done on time and on budget.” 

US Biotech Company