c4c-S - International Symposium Ongoing trial support service - 06.11.24

Sep 11, 2026

Service framework for paediatric clinical trial execution across 21 European countries, developed through the c4c project. The approach centers on a dedicated Single Point of Contact (SPoC) to streamline communications among sponsors, sites, and trial teams, while providing site set-up, recruitment support, and engagement with defined roles via a co-developed RASCI template. National hubs enable rapid issue resolution through structured escalation workflows, metrics-driven timelines, and continuous feedback loops to standardize SOPs and maintain operational momentum.

LanguageEnglish

CategoryPosters

FormatPDF

Pages1

AccessFree to download

Benefits

Centralised coordination (SPoC)

Site set-up, recruitment and engagement services

Quick issue resolution via National Hubs

Problem statement

Communication gaps

Recruitment bottlenecks

Lack of clear processes

Work undertaken

Solutions offered

Cascade CDA process

RASCI model adoption

Metrics and proactive escalation procedures

Feedback loops and reviews

Key outcomes and results

Operational readiness and rollout via c4c-S

Network-wide standardization and enhanced communication pathways

Proof of Viability (PoV) studies and reach

Developing streamlined services to support paediatric trial conduct across 21 countries in Europe Sabah Attar 1, Chloe Bickerstaff 1, Andrew Morrison 1, Dawn Stewart-Ryan1, Mark Turner 1, Francisca Patuleia Figueiras 2, Ines Lopes Amaral 2, Catarina Raposo 2 and Ricardo Fernandes 2 1. University of Liverpool, 2. Association for Research and Development of the Faculty of Medicine (AIDFM). Acknowledgements: c4c project Work Package 2 & 7 Leads and Task Teams and c4c National Hubs BENEFITS • Centralised Coordination: A dedicated Single Point of Contact (SPoC), to streamline communication between sponsors, sites, and trial teams. • Services for site set-up, recruitment and site engagement: metric driven with clear roles and responsibilities across NHs, sites & Sponsor representative teams through a co-developed RASCI template. • Quick Issue Resolution through National Hubs: Communications cycle and escalation allowing for continuous oversight of site activities support processes stay on track, minimising delays. PROBLEM STATEMENT Communication Gaps: trials face coordination challenges due to inconsistent communication cycles across sites, countries, sponsors, and sponsor represenatatives. Recruitment Bottlenecks: slow recruitment due to limited site engagement or unforeseen challenges. Lack of Clear Processes: different processes and approaches requirements were not fully defined, leading to operational inefficiencies. WORK UNDERTAKEN SOLUTIONS OFFERED •Single Point of Contact (SPoC) Workflows, Information System with built in metrics on response times, specific personnel to ensure smoother communication and faster issue resolution. •Cascade CDA process to enable rapid set up of site support, that enables activation of support across multiple sites with just one contract for the Sponsor. •RASCI Model Adoption to clarify roles and minimize overlaps between sponsors, NHs, and trial teams. •Metrics identified with industry, NH and site input and built into service flow to ensure consistent timelines and quality across all NHs. •Proactive Issue Escalation Procedures: Developed escalation protocols to resolve recruitment and data challenges without delay •Feedback Loops and Reviews for continuous service improvement, with all NHs and trial teams to adapt processes and resolve ongoing issues in real time. KEY OUTCOMES Services reached full operational readiness, supporting trial execution across multiple countries, and will be rolled out through c4c-S, with: • Efficient Issue Management: Faster ‘pathways’ for resolution of challenges during trials • Network-wide Standardization: SOPs and templates and standards adopted across all National hubs, improving consistency in trial service management. • Enhanced Communication Pathways: NH oversight ensured recruitment issues were escalated and acted upon. • Feedback loops: Helped maintain trial momentum and align operations with sponsor expectations. RESULTS Figure 1. Number of sites, across all NHs, that participated in 8 Proof of Viability (PoV) Studies to test the performance and viability of the c4c network UK CH SE ES PT PL NO NL IT IE HU *Additional industry studies added to the portfolio through recommendations of Industry PoV trials Single Point of Contact (SPoC) for 20 NHs and +220 clinical sites Monthly progress calls between SPoC and Sponsor/ trial team. National Hubs knowledge of local regulatory processes in each country contributes to faster approval process National Hubs working relationships with Local Sponsor representatives for joint communications and rollout of support HOW TO ENGAGE WITH US Find out how c4c-S can support your paediatirc clinical trial Presentation created with PresentationGO templates and graphics ([www.presentationgo.com](www.presentationgo.com) )

FAQs

What is the role of the Single Point of Contact (SPoC) in the c4c-S service?

SPoC provides a dedicated single channel to streamline communication between sponsors, sites, and trial teams. It supports faster issue resolution using workflows and built-in metrics on response times.

How do National Hubs help during paediatric trial execution?

National Hubs support site activities by enabling rapid escalation and oversight, and by leveraging knowledge of local regulatory processes. They also work with local sponsor representatives for coordinated communications and rollout.

Which mechanisms are used to improve recruitment and address operational delays?

The service defines site engagement with clear roles and responsibilities through a co-developed RASCI template. It also includes proactive escalation protocols, feedback loops, and continuous reviews to adapt processes in real time.

Sep 11, 2026

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