Service Description

Cro was contracted to execute pivotal study for a breast cancer biologic compound. The scope of work included feasibility, selection and contracting of sites ,regulatory filing, execution of trial through data lock. Cro was also contracted to deliver study within agreed budget and time.

What Went Well

Cro worked closely with the asset team to understand the development strategy and provide insights in terms of study design to optimize timeline and budget. The Cro recommendation in terms of site selection and timing/ budget was the result of both feasibility study and ability to leverage database and clinicians experience. Change in standard of care was also a consideration.

What Could Be Improved

Cro experienced some challenges getting a sites up and running and recruiting patients. While the study was challenging, the cross wasn't as proactive as the team would have liked, conducting activities in sequence rather in parallel. For examples, the Cfo had to go back nd identified new sites to supplement the study which took time. Instead they should have included back up sites as part of feasibility study to ensure we could quickly activate those sites.

Lessons Learned from the Experience

early engagement, and clear communication of study objectives early on is critical to enable success of cro. Close monitoring and good communication with asset team allows to quickly make decision on operational issues that come up. Risk mitigation strategies should be defined early on and communicate broadly with cro and asset teams.