Clinical Trial Rescue: Leadership Approach To Propel Clinical Development

By Rashida Challenger

A rare disease biotechnology company faced challenges in its gene therapy clinical trial, including a poor performing Clinical Trial Leader and a teetering clinical operations strategy. They approached Halloran Consulting Group for their expertise in rare diseases, gene therapy, and clinical trial leadership. Halloran provided a seasoned professional who quickly assessed the gaps and challenges in the clinical operations framework and implemented solutions to move the trial forward.

Through a six-step plan, Halloran was able to improve the company's clinical strategy and operations, resulting in the lifting of a clinical hold and meeting of their first-in-patient goal. Halloran also supported the company in hiring a full-time replacement and provided a transition plan. Without Halloran's support, the gene therapy trial would have been delayed.

Delve into the details of this case study to learn more about how Halloran's assistance was able to improve development and operations, communication workflow, and establish workstreams.