CORE LAB SERVICES EXPERTS DEDICATED TO OUR SPONSORS CERC offers angiographic, OCT, ECG, CT-SCAN, ECHO – TTE, MRI and IVUS analysis for core laboratory purposes. From complete trial management to comprehensive core lab services, CERC provides sponsors with the complete resources and superior services to meet every combination of needs. CERC combines the simplification of the process through scientific knowledge and leadership, with experienced project teams. CERC provides a superior quality in all aspects of core lab services. CERC’s core lab services include high quality analysis, dedicated resources, expert consulting and much more. CERC’s teams are composed of clinical trial professionals with extensive experience in core lab services led by internationally renowned experts ← Trial management CEC, DSMB AND MEDICAL DEVICE VIGILANCE...
SERVICES TAILORED TO YOUR SPECIFIC NEEDS Trial management can encompass entire projects, from strategic design advice to clinical report production, or specific individual tasks. CERC provides exhaustive services and expert assistance in the whole cycle of clinical trials and clinical data management. CERC has comprehensive expertise in the design of trials, selection of investigators and sites, creation of study documents, clinical monitoring, core laboratory analysis, data management and compliance with regulatory and quality requirements. CERC manages a wide variety of clinical trials for both its local and international partners. The diversity of its team with 18 different languages spoken allows CERC to manage a multi-national trial or a regional one. CERC has the expertise and resources for virtually all of your clinical trial requirements. CERC has a longstanding successful history of patient enrolment in trials from post market registry to double blind randomized trial. As a clinical research organization, we always endeavour to exceed our sponsors’ expectations. ← REGULATORY SUBMISSIONS CORE LAB SERVICES...
REGULATORY SUBMISSIONS A MUST-HAVE AND A UNIQUE EXPERTISE CERC ensures that all regulatory requirements are fulfilled before patient enrolment. Regulatory support is crucial for the success of the trial. It is affected by guidelines, standards, specific requirements… Using the required format increases successful review. CERC can assist you in preparing and submitting your regulatory application, from the beginning of the process until you apply. Ensuring compliance with all regulatory agency technical requirements so that your submission will pass technical validation and arrive to the reviewers without delay is an expertise we acquired. Regulatory agencies are various around the world. Submissions can be sent electronically through an Electronic Submissions Gateway when there is one or through document publishing, CDISC dataset preparation, SPL build, standard letter or A4 paper submission printing for agencies or EU Member States. Because of our knowledge of the regulatory authorities expectations, we have an excellent reputation for filing high-quality, easily reviewable forms and applications. ← STRATEGIC PLANNING Trial management...
STRATEGIC PLANNING A FIRST STEP… BUT NOT ONLY! Strategic planning is not only a first step for us. It is an essential key element for the success of your trial. The development plan, the regulatory authorities, the timing of the trial. We take at this stage every aspect of the trial to make it successful in the shortest possible time. The strategic planning guides the overall management and budget of the project and should be done as early as possible to set up clear vision of the project. We look at your trial from a very broad, long-range perspective to avoid failure. Strategic planning is not only thinking globally : we guide the overall management and budget of the project. We provide exhaustive services and expert assistance in the whole cycle of clinical trials. This stage helps us to have a comprehensive expertise in the design of trials, selection of investigators and sites, creation of study documents and clinical monitoring. REGULATORY SUBMISSIONS...
