Case Study 7: Tight Timelines - Recruitment Short - Phase II Protocol

The Challenge

A small biotechnology firm approached us with a protocol for their Phase II study. With tight timelines and a limited number of sites in New Zealand and Australia interested, additional strain was put on sites that participated.

Some of the sites were unfamiliar with the large data collection associated with early phase protocols, while others were unable to recruit sufficient patient numbers. This resulted in a request to sites that were already recruiting well to make up the shortfall.

On top of this, the sponsor had key milestones to meet and resources that only stretched so far. Sound familiar?

The Response

1. BELTAS chose sites that could facilitate the long days required by the protocol

2. We provided clear and comprehensive reports to the sponsor detailing issues, escalation and resolution plans

3. Flexibility was key in extending the patient quota in New Zealand, which had associated impact on workload

The Results

. 2/3 of the patients were recruited in New Zealand at just two of the five sites across the region

. Owing to the study extension and site staff changes, scale issues resulted in a high workload within a short timeline to meet data deadlines. However good relations with site staff ensured this was managed satisfactorily

. Lessons learnt have been documented and team training has proactively ensured the risk of repeated issues is significantly reduced

Client Feedback

"I want to thank you all for your tremendous support, effort and sheer determination from Day One, and throughout this study. In particular, we really appreciate all the late nights and countless hours put in over the last few weeks to wrap this up.

It has been an absolute pleasure working with all of you, and I look forward to completing all aspects of this study and engaging in future programs."
- Executive VP of Clinical Development

"Congratulations indeed. Many thanks to everyone for all of your hard work. This is a great accomplishment by a fantastic team. Very well done!"
- Head of Clinical Operations

"Congratulations indeed. Many thanks to everyone for all of your hard work. This is a great accomplishment by a fantastic team. Very well done!"

- Head of Clinical Operations