Innovation.public.lu

Competence Centre - Clinical and Epidemiological Main axes of research
The main objectives of the CIEC are to promote clinical research and to assist and support clinical research projects in Luxembourg. It can provide any kind of logistic support to hospitals or physicians interested in clinical trials. It is also a contact partner for pharmaceutical industries interested in conducting clinical trials in Luxembourg.
The CIEC aims to develop a national clinical research network including clinicians and physicians in various medical fields in order to react in a timely manner to demands emanating from potential sponsors.
The CIEC is an infrastructure intended to prepare and realise, partially or totally, clinical research projects based on patients or healthy volunteers, in the respect of Good Clinical Practice (ICH-GCP) and Quality Assurance. It provides opportunities for internal and external research teams to consolidate fundamental and experimental findings by a clinical research study in healthy volunteers or patients. The CIEC acts at the interface between fundamental and clinical research, i.e. translational research and helps providing new scientific and medical knowledge.
The CIEC is committed to:
Scientific value and authenticity of collected data Security of the patients, respect of the person and confidentiality of patient data ICH-GCP and standard operating procedures (SOPs) in order to assure quality regarding the clinical trials performed by CIEC. It has compiled and validated an own SOP manual which its team is following Application domains
CIEC contributes with logistic help at all stages of a clinical research project while complying with legal and ethical standards. CIEC also organises training and education for physicians and nurses.
Up to date, a total of 14 ongoing trials cover 5 different therapeutic fields. These include : A public health study (nutrition and cardiovascular disease) in collaboration with the Neurology department at Centre Hospitalier de Luxembourg (CHL) CIEC supports IBBL (Integrated BioBank of Luxemburg) in a Lung Cancer Study in association with CHL in means of patients’ clinical data as well as tissue, saliva and blood collections A single center radio-diagnostic study using FNa18 in orthopedic diseases is in preparation in collaboration with CHL Further Pharma projects in oncology are in preparation Current research projects
Non interventional study to follow and evaluate patients with advanced non-small cell lung cancer (NSCLC) who are treated in a second line setting with Erlotinib in a "real life" clinical setting.
Randomized multicentric Phase II study of prolonged adjuvant Temozolomide or "stop and go" in glioblastoma patients.
Non-interventional observational post authorisation safety study of subjects treated with lenalidomide.
Multicenter, randomized, parallel group efficacy and safety study for the prevention of venous thromboembolism in hospitalised medically ill patients comparing rivaroxaban with enoxaparin.
Open-label expanded access study of Lapatinib and Capecitabine therapy in subjects with ErbB2 over-expressing locally advanced or metastatic breast cancer.
Biomarker discovery and validation in lung cancer.
Prospective evaluation of small molecule EGFR-1 tyrosine kinase inhibition as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harbouring a mutant EGFR gene.
Multinational, multicenter, post-authorisation, prospective observational cohort study to assess the profile of vildagliptin and the fixed-dose combination of vildagliptin/metformin relative to comparator oral anti-diabetic drugs in patients with type 2 diabetes in a real-world setting.
Current practice of Aranesp in the management of haemoglobin levels: an observational international cancer Evaluation.
Area of competence
▪ Life Sciences, health and biotechnology Technology keywords
▪ Pharmaceutical Products/Drugs ▪ Neurology, Brain Research ▪ Medical Research ▪ Heart and blood circulation illnesses ▪ Diseases ▪ Cytology, Cancerology, Oncology ▪ Clinical Research, Trials ▪ Biostatistics, Epidemiology ▪ Education and Training Contact details
1A, rue Thomas Edison, L-1445 StrassenPhone: +352 26 97 08 07Fax: +352 26 97 08 10Email: [email protected]: http://www.crp-sante.lu Equipment
Clinical Research Software:
ORIAM® Trial management and tracking of clinical data DATABIOTEC® Management of human samplings IT Server guaranteeing the security of patient data (ORACLE) Medical equipment:
Pulse Transit Time (PTT) assessments (arterial pulse pressure wave travel time from the aortic valve to the periphery) Products and services
Assistance in developing individual clinical research projects Submission of research projects to “Comité National d’Ethique de Recherche” (CNER), “Commission Nationale de Protection des Données” (CNPD) and/or the Ministry of Health Logistic support for conducting clinical trials including writing of protocols and case report forms, contracting insurance, elaborating financial conventions, data monitoring and collection, data base set up, statistical analysis, exploitation and publication of results Standard Operating Procedures (SOP): the entire CIEC Team is working according to own CIEC SOP Manual based on ICH - GCP Management of patient visits: Individual patient consultations at CIEC (2 patient consultation rooms); Room and material for blood sampling, processing and storage Major Partnerships and collaborations
National: Centre Hospitalier Emile Mayrisch (CHEM); Centre Hospitalier de Luxembourg (CHL);
Centre Hospitalier du Nord (Hôpital St. Louis, Ettelbruck); Zithaklinik; National Centre for
Radiotherapy: Centre François Baclesse (CFB)
International: Translational Genomics Research Institute (TGen) (US); Amgen (BE); Bayer SA-
NV (BE); Celgene BeLux (BE); GlaxoSmithKline, N.V. Novartis Pharma S.A (BE); NV Roche SA
(BE); Université Catholique de Louvain - Oncologie Médicale, Centre du Cancer, Cliniques
Universitaires St. Luc (BE); Oncologie Médicale – Centre d’Oncologie, Hôpital Académique-
Université Libre de Bruxelles (BE); Astra Zeneca NV/SA (BE)
Human resources
Researchers (prof., ass. Prof., post-docs, PhD): 2Doctoral students and students: 0Engineers: 0Technicians: 5Other: 1 R&D Contact Person
Dr. Anna CHIOTI
Position: Head of Research Unit
Phone: +352 26 97 08 00
Email: [email protected]
Dr. Manon GANTENBEIN
Position: CIEC Coordinator
Phone: +352 26 97 08 07
Email: [email protected]

Source: http://www.innovation.public.lu/application/catalogue/instituts/clinical-and-epidemiological-investigation-centre-ciec/pdf_en_clinical-and-epidemiological-investigation-centre-ciec.pdf