Study Preparatory Activities

The Trials Accelerator can support with the initial trials activities such as protocol development or regulatory support.

Protocol Development

The Protocol for a Clinical Study describes the background, rationale, objectives, design, methodology, statistical considerations and organisation of a clinical research study. The Clinical Study Protocol ensures safety of trial participants and the integrity of the clinical data. 

 The Trials Accelerator can assist with Protocol Development through consultation to understand the product or intervention under investigation, by providing templates and connecting academic and commercial partners with subject matter experts and appropriate bodies where relevant.  

The Trial Design Advisory Service can help refine the research question, funnelling novel research questions that address unmet clinical needs. Incorporating innovative methodology to improve the planning, implementation and reporting of studies. Choosing appropriate outcomes and controls for the population, assisting with sample size calculations to ensure the study is appropriately powered, and minimising bias through allocation concealment where possible and randomisation where appropriate. 

Regulatory Support

The Trials Accelerator can help you navigate within the Irish regulatory framework and support your applications to the competent authorities. 

The Trials Accelerator can assist with device classification and subsequent regulatory pathway processes, preparing documentation for ethics applications, pre-submission meetings with the competent authority and regulatory submissions, data protection impact assessments and submissions to CRDO for studies that are going to be delivered in CRFG. 

To request assistance for study start-up activities, please contact our team members who will respond to your enquiry at the earliest opportunity.