The role of the Clinical Trials Conduct Unit (CTCU) is to conduct clinical studies in a professional manner, in compliance with European Directives, regulations and Good Clinical Practice – GCP). These clinical studies are carried out in collaboration with pharmaceutical firms and/or academic partners. The Institut Bordet also implements its own clinical studies.
Clinical studies are very closely monitored and must meet the quality criteria essential for ensuring that patients who participate in the studies are protected, while also maintaining a very high level of medical care. Patient well-being is always at the centre of our concerns. The link between the CTCU and the various medical departments is very close. A specific care unit is devoted solely to welcoming patients included in clinical trials: the Novel Treatment Unit.
The clinical studies conducted at the Institut Bordet are coordinated by CTCU research physicians and teams. These doctors are responsible for monitoring patients and collecting data.
Each year, the CTCU welcomes and supervises students as part of their training (nurses, pharmacists, PhD students).
In addition, our researchers supervise young trainee doctors in clinical research on a weekly basis. Also, twice a year, Dr Aftimos gives a course on clinical studies for these young doctors.
Our researchers participate as speakers in the “Midis des Amis” lecture series.
Under the responsibility of the research physician, the clinical research nurses and clinical study coordinators organise and coordinate the different aspects of the clinical studies. They are the point of contact for patients participating in clinical trials and also for all our research partners. They provide personalised support for the patient and are the primary contact throughout treatment.
Explanation of roles:
- The principal researcher is a doctor who manages the execution of the clinical trial on our site. He undertakes to conduct the research in accordance with good clinical practice and in line with the protocol. He appoints his collaborators and determines their role in the study.
- The co-researchers are doctors who include and inform the patients in the trials. They prescribe their treatment, are responsible for monitoring patients, in accordance with the protocol, and for the collection of data.
- The research nurses and clinical study coordinators assist the researchers throughout the trial. Their role is to inform patients, manage appointment planning, administer the treatment (especially in Phase 1), gather information, manage communication between the different parties involved in the study and to implement the technical requirements of the protocol. They are the point of contact for the patient, researchers and those promoting the study.
- The data managers are the encoders who assist the study coordinators and provide information relating to the clinical trials to the promoter of the study (a pharmaceutical firm or academic centre).
- The administrative & start-up coordinator is an administrative assistant who assists the researcher in setting up all new research projects at the Institut Bordet.
- The quality manager implements and manages standardised operating procedures to facilitate the execution of quality clinical trials, in accordance with the rules of good clinical practice. She designs and implements methods and tools available to the CTCU for the maintenance and development of quality.
CTCU Operations Manager
- Michel Dubuisson
- Ioanna Laios
Administrative & start up coordinator
- Sarah Peault
- Barbara Servais
- Iraida Agaeva
- M'Kinansoi Lare
- Marilia Bezerra (aussi BUP IDM)
Imaging Data Manager (IDM) and part-time DM
- Renée Nsombo Lukusa
- Herve Manga, pour l’Hématologie
- Bastienne Bouché
PSOM and Trial Submission CTCU
- Marie-Aline Echterbille
Study (Nurse) Coordinatoeurs :
- For Medical Oncology and Radiotherapy
- Sylvie Bartholomeus
- Annakim Bergström
- Fanny Bustin
- Alfino Buttice
- Nathalie De Naeijer
- Wissam Tanios
- Patricia N’daya Bilolo
- Daniela Wayllace
- Joyce Haddad
- Michèle Schroeder
- Sophie Stylen
- Berline Tako
- Rana Ali Osman
- Sophie Coutinho
- Ghenwa El Hajj
- Rita Mouhanna
- Pierre-André Bouchonville
- For Haematology
- Admin Support and Coordinatrice Implémentation
- Bénédicte Vucic
- Study (NURSE) Coord.
- Brandy Liliane A Troisfontaine
- Ellen De Cuyper
- Lina Adu Poku (en congé de maternité, revient en 01/2024)
- Marie De Clippele
- Aude Bovenkamp
- Admin Support and Coordinatrice Implémentation
- For Radiotherapy
- Clémence Al Wardi (en congé de maternité, revient en 01/2024)
- Hélène Gilson
- Carole Janssen
- For Thoracic Oncology, Oncological Emergencies and Intensive Care
- Nathalie Leclercq
- For General Surgery
- Sophie Vankerckhove
- For Infectiology
- Vanessa Coubeaux
- For Nuclear Medecine
- Wendy Delbart
- Loubna Taraji Schiltz
- Gabriella Critchi
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