Clinical Unit
Clinical Unit
The clinical unit features a spacious facility fully equipped to conduct vaccine research according to the highest standards. Our streamlined processes ensure that every stage of the study is handled efficiently, from initial participant recruitment and screening to data collection and analysis.
CEVAC has a dedicated clinical team with extensive experience in conducting clinical vaccine trials. The team includes medical doctors (investigators), study nurses, study coordinators, administrative assistants, and a clinical unit manager.
All team members receive training in ICH-GCP every two years and regularly attend seminars in the field to stay updated with the latest developments in clinical research.
CEVAC has extensive experience in assisting and advising pharmaceutical companies during the concept phase of clinical studies, demonstrating our readiness to support every aspect of your research. Our expertise includes providing valuable input on study design, conducting thorough protocol reviews, and offering comprehensive guidance to ensure the success of your clinical trial.
CEVAC has its own volunteer database, which includes more than 12000 potential participants for enrollment. In addition to this database, we collaborate with Ghent University Hospital, and effectively use social media and other media for participant outreach.
This multifaceted approach ensures a broad and diverse pool of candidates for our clinical trials.
To ensure the suitability of potential participants, we conduct a thorough pre-screening process using a detailed medical questionnaire approved by the local Ethics Committee (EC). This protocol specific medical survey allows us to accurately preselect participants based on their clinical profiles, including co-morbidities and medical histories, as well as their willingness to participate. This rigorous approach helps to identify the most appropriate candidates for your clinical study, optimizing trial efficiency and outcomes.
The crucial step of sharing information and obtaining informed consent is consistently managed by the Principal Investigator and our Sub-Investigators . Participants are thoroughly screened in accordance with the protocol, with a strong focus on their safety.
Prior to their visit, participants always receive the Informed Consent Form and are encouraged to read the document very thoroughly.
During the first study visit, we ensure that all study related questions from participants are addressed, resulting in a clear understanding of the study and ensuring their informed participation.
Our team has extensive experience in executing study procedures, including blood collection, vaccination, (serious) adverse event (AE) reporting, and measurement of vital signs, all in accordance with the specific protocol of each clinical trial.
A dedicated study coordinator is assigned to every trial, closely overseeing the study and acting as the main contact person for the Clinical Research Associate (CRA) or sponsor delegate.
Weekly meetings ensure that the entire team receives regular refreshers on the study and stays up to date with protocol amendments, changes in study procedures, and any other relevant updates.
Medical events are discussed on a regular base within the medical team of investigators.
CEVAC uses a custom-made software program for various purposes, including scheduling study visits within the expected time window, tracking contacts with participants, and managing participant reimbursements.
This resource, developed by pharma.be, is a tool for understanding the unique advantages that Belgium offers in the clinical research landscape.
To facilitate collaborations between research institutions and sponsors and/or CRO’s, we utilize a standardized template for contracts developed by Pharma.be. This template ensures clarity, consistency, and compliance with regulatory requirements.
We recommend the use of a suggested template for Informed Consent Forms (ICFs) relating to vaccine research. This template is specifically customized to meet the requirements of vaccine studies in Belgium and serves as a guide for sponsors interested in conducting vaccine trials.
For a more comprehensive understanding of the Clinical Trial Regulation (CTR) in Belgium, including details on the streamlined process for mononational phase 1 trials, please refer to this informative link: CTR in Belgium.
Facilities
The CEVAC Clinical Unit, located within Ghent University Hospital, provides a professional environment for conducting clinical research.
- Two storage rooms for vaccines with eight refrigerators, one -20°C freezer, one -80°C freezer, room temperature cabinets, monitored with a continuous temperature sensor and a back-up system.
- Twelve examination cabinets
- Three waiting rooms
- Multiple vaccination cabinets
- Two cabinets for processing and testing urine samples
- Two reception areas
- Two cabinets dedicated to taking swabs
- Two meeting rooms
- Five office spaces
- Monitoring rooms for CRA’s
Services
For more information about CEVAC’s research, collaborations, or to inquire about our services and facilities, please contact us.
Our team is available to provide detailed information and answer any questions related to our clinical trials, laboratory capabilities, and research projects. Reach out to us to learn more about our impact in vaccine research and how we can work together to advance healthcare solutions.
Our commitment at CEVAC to advancing clinical research in vaccine development is further strengthened by our adherence to streamlined procedures and the utilization of standardized templates and guidelines, especially pertinent to the Belgian research context.
