OPTI-XIENCE Brief summary An international, multicentre, single-arm and prospective study with a historical control group (XIENCE V USA study) to evaluate the clinical outcome of high-risk patients undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stent implantation using intracoronary tools for PCI guidance and optimization. The hypothesis is that the clinical outcome of patients undergoing PCI with stent implantation can be improved with the use of intracoronary imaging (OCT or IVUS) and/or intracoronary pressure measurements (pressure guidewire) that allow PCI optimization compared with PCI guided by angiography alone. Primary endpoints The 1-year TLF rate, defined as a composite rate of cardiac death, target-vessel MI, and ischemia-driven TLR by either PCI or CABG, within 1 year after PCI. For comparison purposes, the definition of the primary endpoint is identical to that used in the XIENCE V USA study (ARC-1 definition). CERC Services Study management in France Kick off activities, Clinical trial documentation review, Regulatory submissions, Contract management, Project management, Monitoring, Safety reporting, Countries France managed by CERC. Spain and Portugal managed by others CRO. Centers number 17 sites in France managed by CERC....
EESIS-FR Brief summary This is a multicentre post marketing study in France evaluating the safety and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms at the carotid and basilar terminus. The eCLIPs device is the first neuro device that has gained Innovation funding (in French, “Forfait innovation”) from French National Authority for Health (Haute Autorité de santé – HAS). Primary endpoints Efficacy Endpoint: Proportion of patients with aneurysms with complete occlusion (Raymond-Roy score 1) with no recurrence or re-treatment at 12 months. Safety Endpoint: Proportion of patients with a major stroke or non-accidental death within 30 days (procedural) or with a major ipsilateral stroke or neurological death between 31 days and 12 months. CERC Services Study documents review Project management Sites’ contract management EDC and data management Monitoring activities Safety reporting CEC and DSMB activities Final study report Countries France Centers number...
CRA Manager The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases. Chaired by five interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals. CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy. CERC is an Entreprise à Mission. We are looking for an experienced CRA Manager. Job Description Your mission will be to guide and lead a team of International Clinical Research Associates, in order to allow the management and smooth running of clinical trials by a qualified, motivated and competent team, to do this you will need: Ensure the training of its team of Clinical Research Associates in the procedures of the company, the sponsor (s) and clinical trials Enforce procedures and regulations with their team of Clinical Research Associates Enforce the various performance indices required by the company Ensure the link between the Project Manager Optimize the distribution of the workload according to the needs of the projects Ensure the recruitment of teams of Clinical Research Associates Monitor the development of skills and ensure the professional development of each member of his team Skills Scientific training (Bac +5 minimum) Knowledge of clinical trial procedures, Good Clinical Practices and clinical regulations in the field of research Previous experience in team management CRA experience Fluency in written and...
🔎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...
