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WilMar Clinical Consulting offers an array of services including-
Clinical Trial Oversight/Management - WilMar can manage a clinical research trial from start to finish. This includes developing an efficient monitoring plan. Each trial is different and therefore the monitoring plan should be tailored to meet each trial’s goals, timelines, enrollment and budget. We can create a monitoring plan specifically designed to meet your goals and budget. In addition WilMar’s project manager will assure that monitors/CRAs perform their duties in a timely manner and that the study timelines and budgets are adhered to.
Clinical Trial Monitoring - All WilMar monitors/CRAs have a minimum of 5 years of experience and are experienced in risk-based monitoring. The monitors/CRAs are decentralized using a regional model. This model enhances productivity and dramatically cuts travel related expenses associated with monitoring clinical research sites. WilMar’s experienced, regionally based, monitors/CRAs will source data verify all collected data as they assure GCP compliance as well as protocol adherence.
Training - WilMar offers training for investigative sites as well as for individuals seeking a career in the clinical research industry. Our training is designed to sharpen the skills of the research professionals within your organization. We can also provide protocol specific training to minimize any protocol compliance issues. In addition, WilMar offers training designed to introduce the concepts and requirements of clinical research which educate and prepare individuals to work in various roles within the clinical research industry
Clinical Trial Compliance Review/Auditing – WilMar can assess your existing, or develop a new, clinical research compliance and quality program. This will ensure best practices in ICH-GCP guidelines as well as FDA regulations. We can create tools for Corrective Action Preventive Action (CAPA)’ and ‘Root Cause Analysis (RCA) by applying methods and implementing key factors such as good documentation practices and risk management strategies that support and enhance the excellence of a quality management system. In addition we can remediate audit findings and create a compliance training program.
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