QUALITY POLICY The CERC offers to the Medical Device and Pharmaceutical Industries and academia, a scientific research organisation devoted to advanced and complex clinical developments, specifically in the cardiovascular diseases area in an international context. With offices providing services in about 40 countries, our team has a strong knowledge of local regulations, standards of care and customer’s culture to deliver the highest quality of work for studies we are entrusted. This Quality policy applies to all employees within CERC and CERC Asia as well as other third parties working on behalf of CERC. In order to provide our Clients with high-quality services, we have implemented a Quality and Process Management System able to: guarantee compliance with the applicable regulations, meets the Client’s expectations and requirements regarding the services provided, ensure the continuous improvement in our process and procedures We commit to: ensure compliance with applicable regulations, continuously improve the effectiveness of our system ensure compliance with the timelines defined with our clients, ensure continuous support to our clients and other interested parties, provide required services and go beyond our expectations enhance the competence of CERC staff strengthen the CERC knowledge by having the staff turnover as low as possible. The maintenance of CERC Quality and Process Management System is performed by CERC Quality Team. Meeting Client satisfaction and service requirements also resides in the implication of each individual within CERC. We, therefore, trust each staff member to actively participate in the setting forth of this quality policy and in the Quality Management System, for the benefit of Client satisfaction, for meeting the services objectives, and thus for the benefit...
PUBLICATION CENTER CERC team offers comprehensive publication guidance from selection of appropriate journals to assistance in the writing of abstracts and articles in collaboration with the principal...
TRIAL VISIBILITY MAXIMIZING TRIAL VISIBILITY Thanks to our network of key opinion leaders, we provides guidance on how to improve clinical trial promotion and visibility. We are all actively involved in major cardiology meetings as faculty or course directors. Our experts know which data goes to a central stage. Working with CERC will make your trial visible worldwide. Our international network is here to ensure your data global...
HEALTH ECONOMICS A REAL WORLD EVIDENCED-BASED DATA CERC helps its clients design their clinical research and product development strategies by providing support in health economics analysis and guidance on reimbursement issues specific to each European country. CERC’s services in Health Economics bring real-world evidenced-based input to your project. We have first-hand knowledge of health economics challenges and the ability to deliver solutions based on practical and empirical evidence. Our large, clinically rich databases provide a comprehensive patient picture, and our recognized health outcomes research experts analyze, interpret and communicate the trial findings. Our health outcomes experts draw on their long strategic experience in analysis to support decisions related to market access. ← BIOMETRY TRIAL VISIBILITY...
BIOMETRY EXPERTS FOR QUALITY DATA As clinical trials and regulations become more complex, it is important to work with a biostatistician who understands the current regulatory environment. CERC provides a comprehensive range of clinical research services, including the full range of biometric services in alliance with our biostatisticians and data managers. We also have the possibility of obtaining academic statistical analysis thanks to a regular collaboration with Leuven University. CERC provide clinical biostatistics services such as trial design, sample size determination, statistical analysis plan or randomization management. We conduct all our trials, from small FIM to large multicenter randomised trial via electronic Case Report Form! ← CEC, DSMB AND MEDICAL DEVICE VIGILANCE HEALTH ECONOMY...
CEC, DSMB AND MEDICAL DEVICE VIGILANCE OUR NETWORK MAKES THE DIFFERENCE DSMBs and CECs provide clinical oversight and monitoring of a trial. CERC sets up and coordinates CEC and DSMB meetings involving prominent physicians with the highest level of expertise. Such committees are being increasingly required by the authorities to supervise (oversee) clinical trials, especially in areas of cardiovascular research. These committees provide independent oversight of study data and methodology, review adverse events and protocol deviations, and adjudicate endpoints in the case of CECs. According to the size of the trial and the needs of the sponsor, we can organize physical CEC meetings but we also have an e-CEC platform. Since 2005, CERC has been recruiting key opinion leaders in its clinical research areas and managing their activities in a wide range of studies. Our mission is to create committees which regulators can trust. CERC also provides and coordinates AE/SAE and MEDDEV reporting. ← CORE LAB SERVICES BIOMETRY...
