Webinar: How do you design a clinical study that is registration-ready?

From protocol to registration: learn what changes when your endpoint is approval, not publication. Practical guidance on study design, CTIS readiness, GCP execution, and key post-study obligations.

13 October 2026, 16:00 CEST

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Orfenix webinar banner with the title “From Protocol to Registration: Navigating the Hurdles in Clinical Development”, plus “13 October 2026 · 16:00 CEST · Online” and a minimal clinical trial pathway graphic.

Learn how to design a registration-ready clinical study. Built for approval, built for patient access.

After this session you will:   

  • Clearly understand the difference between publishable studies and registration-ready studies
  • Understand what submission readiness requires in practice, and the common validation pitfalls
  • Recognise key execution risks during conduct (GCP expectations, deviations, monitoring, logistics/IMP)
  • Leave with the “From protocol to Registration readiness scan” to pinpoint your top gaps and next actions

What this session is about  

Clinical studies can be designed for different goals: a strong publication, guideline influence, or product registration. But a study that is publishable is not automatically registration-ready.

If your goal is to bring a therapy to patients through marketing authorisation, your study must be built for the “registration lens”: endpoints aligned with the intended label, GCP-grade data integrity, IMP readiness, and a submission package that holds up in CTIS. When these elements are not built in from the start, teams often face delays, rework, or results that cannot be leveraged for approval.

This session is designed to help you navigate that road.

How the session works  

How do you design a study that can ultimately support registration and patient access? We break it down step by step.

During the session, we will unpack the key topics that converge in registration-oriented clinical development, bring these concepts to life through a real case study, and share a practical readiness scan you can apply to your own project.

1. Define the development plan

We map the decisions that determine whether your study can support registration: target product profile, evidence gaps, endpoint strategy, and IMP feasibility.

2. Understand the study submission package 

We break down what “submission-ready” means in practice, what to monitor during validation, and the common pitfalls that cause avoidable delays.

3. Study preparation & conduct

We cover what keeps your study inspection-ready: GCP basics, monitoring, deviation handling, safety reporting routines, and operational/logistics realities.

4. Post-study obligations and timelines 

We outline the key deliverables and deadlines after the last visit: results reporting and lay summary, CSR expectations, and long-term archiving requirements.

5. Case study: Guanabenz

We translate the concepts into reality using the Guanabenz case study, highlighting the decisions that impacted timelines and outcomes.

7. Q&A

This session closes with an open Q&A, giving you the opportunity to ask your questions directly to the expert. 

Who this webinar is for  

This webinar is relevant for:  

  • Principal Investigators  
  • Clinician-scientists  
  • Translational researchers  
  • PhD’ers with an interest in patient impact  
  • Tech transfer professionals
  • Patient representatives  
  • Others involved in moving therapeutic research toward clinical application  

This session is for you if: 

  • You want your study to support marketing authorisation  
  • You want to build evidence that can ultimately lead to patient access  
  • You want to avoid preventable delays and rework

Register now. →

Register now to learn how to design a clinical study that is registration-ready, so your study can truly support patient access.

Hellen Houlleberghs
Hellen holds an international academic background with a BSc in Medical Biochemistry from King’s College London, an MSc in Biomedical Sciences and Management from Leiden University, and a PhD in oncology from the Netherlands Cancer Institute. With nearly a decade of experience managing global phase I–III trials across various indications, including rare diseases, she brings a proactive, collaborative, and results-driven approach to clinical operations.

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