FPI Before Year-end for US-Based Phase II Study

Background > Clinical Site Management and Monitoring for Local Sponsor

PRC Clinical was contracted as the CRO for a Silicon Valley based sponsor for a clinical site management and site monitoring project. The sponsor, an ALS-focused biotechnology company was running a US-based Phase II neuromuscular study with 36 patients on 17 sites.

The sponsor company was headquartered in South San Francisco and focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and other medical conditions.

Challenge > Sponsors Requests FPI Before Year-end

The sponsor awarded the contract to PRC Clinical in October, and requested FPI (First Patient-In) before the end of the year. PRC Clinical was tasked to put together a regulatory plan, source study sites, and prepare patients’ enrollment on a very short timeline, in a busy period of the year.

PRC Clinical quickly began to ‘on-board’ study sites, collect and store regulatory documents, and prepare training materials for the regional CRA team.

Solution > Successfully Planned Investigator Meeting and Study Start-up

Working from our San Bruno project office, our team planned and achieved 95% attendance at the Investigator meeting, and conducted Site Initiation Visits to support this aggressive enrollment timeline. PRC Clinical achieved the FPI on December 29, in accordance with the deadline.

PRC Clinical never lost sight of the sponsors’ objective and timeline. The team had to think outside the box and hired a professional meeting planner to make the investigator meeting a success. The team effort and reliability of PRC Clinical’s experienced CRAs also made possible to get the equipment on site on time to meet the deadline.

PRC Clinical Case History > Key Highlights

• Responsiveness and team effort.
• Team of CRAs with +10 years experience.
• Strong focus on client’s needs and objectives.