A midsize biotechnology company focusing on a large Hepatitis Phase II clinical study was concerned about lagging site initiation and patient recruitment—that was due in part to difficult protocol with a narrow patient population. Given the competitive landscape in this therapeutic area, any delay in completing this project would have negatively impacted the company in subsequent study start-up plans, so the solution needed to be fast and effective.
Dyad lead its client’s study to a successful conclusion by improving the following:
Patient recruitment and retention strategy
CRO assessment, accountability, and project management
Site identification, qualification, and site management planning
Study trouble-shooting, issues escalation, and issues resolution
Through Dyad’s meticulous and strategic approach, the CRO clinical team was re-organized, allowing for the identification of shortfalls within the project team and management. Once identified, the shortfalls were remedied through the implementation of both an aggressive site- and patient-outreach strategy as well as PI web-ex communication to improve communication within the clinical team.