Excellent News for Colibri trial: the 1st recruited patient has been treated successfully on 15th September at the Clinique Pasteur Toulouse , by a team lead by Dr Tchétché! ...
The results of this huge trial were presented: On 08/28 at 2:00 p.m. on the Prime Time channel of the #ESCCongress, by Pr Marco Valgimigli, and simultaneously published in the New England Journal of Medecine, On 08/29 at 10:30 p.m 10:30 on Channel 5 : Pieter Smits, member of the CERC board and other PI of the study, discussed about antiplatelet therapy in high bleeding risk patients with and without oral anticoagulant therapy after coronary stenting. With a simultaneous publication in Circulation! With 111 study sites worldwide, CERC is very proud to be the main CRO in this huge game-changer study. About the trial > https://www.cerc-europe.org/master-dapt/ ...
CERC has adopted a new corporate form integrating the concept of a company with a mission (Entreprise à Mission). This new corporate form reaffirms CERC’s founding principle, namely, improving public health, whilst embodying our dedication to achieving societal and environmental goals. With the patients’ outcomes and quality of life as our ultimate purpose, our mission is to contribute to optimal healthcare via groundbreaking cardiovascular research. CERC is also committed to maintaining high standards of social and environmental corporate sustainability. Our strong commitment to pursuing this mission is now reflected in our new corporate rules and regulations. Our progress will undergo regular assessment under the guidance of an in-house monitoring committee. Finally, being able to join the quest for a third way in the corporate world is a great source of pride for CERC. ...
🔎How the story began, what’s David Hildick-Smith (PI of the trial) interpretation, what are the next steps… You’d like to know the secrets of EBC Main? Watch « EBC Main: behind the curtain » ...
Post-Market Clinical Follow-up (PMCF) is an essential component of Post-Market Surveillance applying to almost all medical devices under the New Medical Device Regulation. According to MDR, PMCF is a continuous process that updates the clinical evaluation of a specific device. It is expected to consist of a proactive collection and evaluation of clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose. The aims of PMCF are to confirm the safety and performance of the device throughout its expected lifetime, identify previously unknown side-effects and monitor the identified side-effects and contraindications, identify and analyse emergent risks on the basis of factual evidence, ensure the continued acceptability of the benefit-risk ratio and to identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct. PMCF studies are performed on a medical device bearing CE-mark within its intended purpose as detailed in the instructions for use of the respective device. They contribute to the risk management process of the device. PMCF studies are to be conducted according to applicable laws and regulations, ethical requirements and should follow appropriate guidance and standards such as ISO14155. The PMCF study plan includes (a) clearly stated objective(s), scientifically sound study design and statistical analysis methods. CERC proposes cost-effective solutions to assist cardiovascular medical device manufacturers ensuring compliant PMCF according to MDR. The proposed services include, but are not limited to: PMCF study protocol writing, electronic data collection system, study site-set-up and follow-up, statistical analysis...
CERC is very proud to announce that its CEO Marie-Claude Morice, has received during EuroPCR 2021 the Andreas Grüntzig Ethica award, « in recognition of her outstanding ongoing contribution to training, education and clinical research in interventional cardiovascular medicine. » Relive this precious moment...
