Case Study: First Global Enrollments Achieved

OVERVIEW

PRC Clinical was contracted by FGK Clinical Research, a Germany-based CRO, to manage the U.S. operations of an international rare disease clinical trial for RHEACELL, a biopharmaceutical company focusing on stem cell therapies. As a global partner to FGK, which was directly contracted by RHEACELL, PRC Clinical played a pivotal role in facilitating the first global patient enrollments for the trial. Spanning 12 countries and involving 100 sites, this milestone highlights PRC Clinical’s exceptional capability in operational coordination and its ability to manage complex, multi-stakeholder trials effectively.

KEY ACHIEVEMENT

• First patients enrolled: PRC Clinical successfully enrolled the first two global patients at a site in Hialeah, Florida
• Global collaboration: PRC Clinical worked in close partnership with FGK to ensure seamless trial operations across 12 countries, achieving timely and effective execution

Challenges Addressed

1. Holiday season logistics: Screening and enrollment occurred during the holiday season, requiring precise logistical planning and robust communication, such as coordinating last-minute travel for site staff and securing expedited courier services to meet protocol deadlines.
2. Global synchronization: PRC Clinical collaborated with FGK and international teams to align processes across different time zones, organizational boundaries and project objectives.
3. Sample shipment coordination: PRC Clinical overcame potential delays caused by holiday-related disruptions by proactively coordinating biological sample shipments.

Strategies Implemented

• Collaborative planning: PRC Clinical partnered closely with FGK to establish clear timelines, communicate milestones and align responsibilities across all stakeholders
• Real-time problem-solving: Urgent logistical challenges, such as sample shipment coordination, were addressed proactively with responsive planning
• Effective communication: Continuous engagement with FGK, clinical sites and vendors ensured alignment on trial execution and streamlined processes, facilitated through regular meetings, detailed progress updates and open communication channels

RESULTS

• Global first: PRC Clinical facilitated the enrollment of the first two patients globally on December 26, 2024, overcoming significant logistical and timing challenges
• Operational excellence: All trial procedures, including data entry and laboratory assessments, were completed within protocol-defined time frames
• Acknowledgment of excellence: PRC Clinical’s collaboration with FGK was widely praised for its precision, dedication and timely execution, achieving success under demanding circumstances

CONCLUSION

As a trusted global partner to FGK Clinical Research, PRC Clinical demonstrated exceptional operational expertise by achieving the first global enrollments for this rare disease trial. Through proactive planning, collaborative engagement and seamless coordination, PRC Clinical continues to set benchmarks for global clinical trial management.

FGK’s leadership and collaborative approach were instrumental in aligning teams across 12 countries and 100 sites, fostering a shared commitment to success. The dedication and professionalism of all global sites played a critical role in reaching this milestone, ensuring the trial’s success and advancing innovative treatments for rare diseases.