Study helps yield full approval for investigative product by FDA for IgAN patients at risk of progression.

Situation

IgA Nephropathy (IgAN) is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure. Primary IgAN can occur at any age, with typical onset during second or third decade of life. For a disease that affects so many at such an early stage of life, research has only very recently begun to discover effective treatments.

When a sponsor that George Clinical has collaborated with on multiple projects had a Phase II multicenter IgAN study, we were their choice for full-service CRO support in North America (NA) and APAC. This partnership, built on reciprocal flexibility, approachability and trust, proved once again to have beneficial outcomes.

Services included Project Management, Regulatory Document Collection, Preparation and Submission to IRB, Site Contract and Budgets, Monitoring, Site Management, Medical Monitoring and Safety Reporting.

“It is an absolute pleasure working with the GC operations and SL team. I’m super impressed with their leadership, professionalism, and attention to detail. From study startup to final database lock, they have met every milestone on or before target. In fact, the team achieved having all CRFs signed about a week before the interim analysis target, which is a tremendous accomplishment. Cannot say enough good things about this team.” – Associate Director, Clinical Operations, Sponsor

Challenges

• Maintain both scientific integrity and site engagement.
• Reduce screen failure rates.
• Manage lab vendor performance.
• Ensure all patients made last visit timeline.

Solutions

On-the ground teams in both NA and APAC, and established relationships with KOLs, sites and vendors maximized scientific integrity and site engagement. Maintaining the same CRA and CTM teams throughout the study streamlined communications and responsiveness. A refined strategy for choosing patients to screen was shared across sites and delivered improved results. When any issues arose, appropriate measures were quickly taken to mitigate risks and maintain forward momentum. Webinars led by KOLs and attended by all stakeholders gave detailed scientific updates, allowed for strategy discussions and kept sites engaged and motivated.

Results

Operationally, George Clinical met all timelines. Recruitment was exceeded and the retention rate was excellent. We are proud to say that our partnership has helped result in full FDA approval of the IP for patients with IgAN at risk of progression.