O4 Research’s services attracted the interest of a new Sponsor. The Sponsor had a failing Phase II European chronic pain study focusing on severe, low back pain which was significantly behind recruitment target, with only 4 months remaining. O4 was consulted to design and execute a compelling ‘roadmap’ to bring the study timelines back on track.
With our experience and expertise in analgesics, we were acutely aware of the specific challenges a study of this nature would present. In consultation with one of the pain specialists from our clinical advisory committee, we formulated a well-defined study operational plan which commanded O4 and site team proactivity throughout. Rescuing this study therefore required an innovative and focused approach, to critically evaluate the patient recruitment progress on an ongoing basis.
We had identified the substantial demand on site staff and therefore it was an imperative that we selected well-resourced experienced sites and augmented this with O4’s on-site management expertise. This strategy proved highly effective and made all the difference!
O4 collated a comprehensive project proposal which provided the Sponsor with the confidence they needed and realistic options to protect the study from overrunning. This, in conjunction with the O4 team’s urgency, focus and attention to detail, led to the development of a successful plan which met recruitment targets within the original deadline. Our approach was multi-faceted and allowed us to complete the project within time and on budget.