Clinical Research Unit 1- Initial feasibility study
Service Description
Overview
Supporting SMEs in defining the key elements of their clinical investigation and preparing a first clinical investigation synopsis. The service provides guidance on study design, number of subjects, endpoints, and other key methodological aspects. It includes access to medical experts and/or clinical methodology experts to provide relevant scientific input and support the development of the synopsis. The service may also include a preliminary budget proposal and support in identifying potential funding opportunities.
How can the service help you?
The service helps SMEs structure their clinical investigation project and turn their initial idea into a clear and feasible first synopsis. It provides access to medical and methodological expertise to support key decisions on study design, endpoints, and sample size. This gives the SME a solid basis for developing the full clinical protocol and planning the associated resources and budget.
How will the service be delivered?
The service can be delivered remotely through meetings with the experts from CHUGA
- Initial meeting to understand the company's needs and to define the clinical question that the study aims to address.
- Based on the information gathered during this discussion, the CHUGA team will identify and engage the most appropriate healthcare professional(s) to act as clinical partners for the project. Establishing a collaboration with a medical partner is a prerequisite for conducting a clinical study at CHUGA.
- Once a suitable clinical partner has been identified and the study objectives have been clarified, we will provide you with a quotation for the development of the study synopsis.
Please note that it is not possible at this stage to provide a quotation for the complete clinical study. The overall study budget depends on several key parameters, most notably the number of subjects to be enrolled, which is determined during the synopsis development phase and the associated study design activities. Consequently, a comprehensive study quotation can only be prepared once the synopsis has been completed and the main study parameters have been defined.
Technical details
The work will be conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP) E6(R3), EU regulation MDR 2017/745 and the ISO 14155:2026 standard when needed.
Service customization
Tasks are tailored to the SME’s specific needs.
Use cases/examples
A company approaches CHUGA with the intention of conducting a clinical study on its medical device or healthcare solution. At this stage, a Non-Disclosure Agreement (NDA) may be signed either before or after the initial scoping meeting, depending on the company's preference and the level of confidentiality required. A first remote scoping meeting of approximately 30 to 60 minutes will then be organized with the TEF Project Manager, the Clinical Studies Project Manager and the company. The purpose of this meeting is to gain a clear understanding of the project and assess its feasibility. Topics typically discussed include:
- The objectives of the study (e.g., CE marking, clinical evidence generation, health economic evaluation, post-market evidence, etc.);
- The clinical need addressed by the solution;
- The overall project budget
- The existence of Key Opinion Leaders (KOLs) already involved in the project;
- The intention to conduct a single-center or multicenter study;
- The preferred sponsorship model and allocation of sponsor responsibilities;
- Previous clinical studies or evaluations already performed on the device;
- Any regulatory constraints, timelines, or specific expectations.
Following this meeting, the Clinical Studies Project Manager will contact the relevant hospital department(s) and present the company's clinical need and project objectives to assess their interest in participating in the study. If the clinical team expresses interest in the project, an internal meeting will be organized with the clinical studies team, methodologists, biostatisticians, and clinicians involved in the study design. The purpose of this meeting is to evaluate the project's requirements and estimate the time and resources needed from each expert. This assessment enables us to provide the company with the most accurate quotation possible for the development of the study synopsis. A quotation for the preparation of the study synopsis will then be provided to the company. Where applicable, the quotation may take into account TEF funding mechanisms and available discounts, depending on the company's eligibility
Provider & Contact
Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.
Sign in or register to see pricingOperational Details
- EU Regulation 2017/745
- Good Clinical Practice
- ISO 14155