This post-market clinical follow-up registry study was designed as an observational, prospective, non-randomised, single-arm, multicenter investigation to evaluate the performance of a vascular graft in patients with end-stage renal disease (ESRD) requiring hemodialysis access. Conducted across four clinical sites in the EMEA region, the study enrolled a total of 72 ESRD patients. The primary objective was to gather real-world evidence on the safety and effectiveness of the vascular graft in a post-market setting. Data collection spanned a defined timeline, capturing outcomes relevant to long-term graft performance and patient management in routine clinical practice.

The study was initially contracted and launched under sponsor SOPs and systems, with the sponsor maintaining full project management oversight. ICON provided support through project management (PM), clinical trial management (CTM), and clinical trial associate (CTA) roles, operating in alignment with the sponsor’s templates.

Midway through the enrolment period, the sponsor transitioned full project management responsibilities to ICON, necessitating a shift to ICON SOPs while continuing to utilise sponsor systems (EDC, CTMS, eTMF). TMF and Safety Management responsibilities remained with the sponsor. This transition introduced operational challenges, particularly in enrolment progress, site identification and activation, and investigator coordination.

To address these challenges, the ICON team developed and implemented study-specific forms, procedures, and plans within 2–3 months. ICON’s Project Management SOPs were adapted to the new scope through tailored documentation, including a study-specific risk management process. The sponsor’s initial monitoring strategy was integrated into ICON’s project specific templates, and site logs were consolidated into a master list to ensure continuity. Metrics report responsibilities were formally handed over from the sponsor to ICON once documentation was finalised. Research associates were retrained on the new processes, with training oversight now managed by the ICON PM/CTM team.

The transition empowered the ICON team with greater decision-making authority and improved site oversight, including enhanced KPI tracking. CTM-led status reporting increased ICON’s awareness of site progress, enabling more effective follow-up and a responsive monitoring strategy. The transition had no impact at the site level, and the sponsor expressed satisfaction with ICON’s performance and the smooth handover.

Future studies transitioning from sponsor to ICON SOPs can benefit from early implementation of study-specific documentation tailored to both ICON processes and sponsor requirements. This approach facilitates a seamless transition at minimal cost implications and ensures operational continuity.