Promotion means operations support to clinical studies sponsorship activities.
CTC is a support service, taking into account aspects of commercial and academic clinical research, with the mission of providing professional assistance to clinical research by centralizing and harmonizing the administrative, operational (eg: data management, monitoring), contractual and financial management of clinical studies.
Wihtin the CTC, the Clinical Trials Support Unit (CTSU) is an operational support unit for academic clinical research into all types of cancer. Certain scientific questions of interest to patients can only be understood by means of academic research. This academic research must comply with all quality standards and legal and regulatory requirements applicable to research. It must also be carried out efficiently.
It is for all these reasons that the Institut Bordet, in a desire to develop and encourage such research, decided to create the CTSU. This unit within the Institution brings together the skills and resources needed to conduct high-level research. The CTSU team is responsible for responding to research questions and evaluating the benefits and risks of drugs and procedures, while always ensuring that the patients participating in the clinical studies are adequately protected.
https://ctc.bordet.be
The CTSU is responsible for the operational management of the clinical studies promoted by the Institut Bordet. It can also provide its services to external promoters, both academic and private (such as pharmaceutical or biotechnology firms).
The CTSU works in close collaboration with the Institut’s medical and scientific team and offers a professional operational structure to support scientific creativity.
The unit provides research support in the following fields:
- project management
- data management
- regulatory matters
- drug safety
- quality management
- monitoring
- translational research
The CTSU regularly organises internal training (i.e; Study Chair training) and seminars on the management of clinical studies, including Good Clinical Practice. This training is designed for those involved in research projects, including research physicians wishing to develop their clinical study conduct skills.
The CTSU also welcomes trainees wishing to gain experience and specific skills in the management of clinical studies: project management, monitoring, regulatory matters and all other activities carried out by the CTSU. These placements allow trainees to familiarise themselves with the conduct of high-level clinical studies in an academic environment.
Applications to : ctsu.info@bordet.be
Ons team
Director of Research Administration
Marielle Sautois
Deputy Director of Research Administration & Head of CTSU Operations
Julie Gaye
Associate Head of CTSU Operations & Quality Manager
Magalie Krieguer
CDIT Team Leader
David Lerens
Project Manager Senior
Diane Delaroche
Regulatory Affairs Manager
Frédéric Hénot
Pharmacovigilance Manager
Marie-Pierre Gauthier
CRA Manager
Sophie Jamin
Data Manager Senior
Vanessa Honvault
31/01/2024
Wetenschapelijke artikelen
Combined Metabolically Active Tumor Volume and Early Metabolic Response Improve Outcome Prediction in Metastatic Colorectal Cancer.
Auteurs : Woff E, Salvatore L, Marmorino F, Genovesi D, Critchi G, Guiot T, Ameye L, Sclafani F, Hendlisz A, Flamen P
Jaar : 2022
Journal : J Nucl Med
Volume : 63
Pagina's : 549-555
Author Correction: FDG positron emission tomography imaging and ctDNA detection as an early dynamic biomarker of everolimus efficacy in advanced luminal breast cancer.
Auteurs : Gombos A, Venet D, Ameye L, Vuylsteke P, Neven P, Richard V, Duhoux FP, Laes JF, Rothe F, Sotiriou C, Paesmans M, Awada A, Guiot T, Flamen P, Piccart-Gebhart M, Ignatiadis M, Gebhart G
Jaar : 2022
Journal : NPJ Breast Cancer
Volume : 8
Pagina's : 38
Genomics of metastatic breast cancer
Auteurs : Geukens T, De Schepper M, Richard F, Maetens M, Van Baelen K, Leduc S, Isnaldi E, Nguyen HL, Bachir I, Vandenberghe E, Van den Bogaert W, Punie K, Neven P, Wildiers H, Floris G, Desmedt C
Jaar : 2022
Journal : Belgian J Medical Oncology
Volume : 16(1)
Pagina's : 18-28
Radiomics software comparison using digital phantom and patient data: IBSI-compliance does not guarantee concordance of feature values.
Auteurs : Paquier Z, Chao SL, Acquisto A, Fenton C, Guiot T, Dhont J, Levillain H, Gulyban A, Bali MA, Reynaert N
Jaar : 2022
Journal : Biomed Phys Eng Express
Volume : 8
The association between adiposity and anti-proliferative response to neoadjuvant endocrine therapy with letrozole in post-menopausal patients with estrogen receptor positive breast cancer.
Auteurs : Isnaldi E, Richard F, De Schepper M, Leduc S, Maetens M, Geukens T, Van Baelen K, Nguyen HL, Rouas G, Zoppoli G, Cardoso F, Sotiriou C, Larsimont D, Floris G, Biganzoli E, Desmedt C
Jaar : 2022
Journal : NPJ Breast Cancer
Volume : 8
Pagina's : 90