Clinical Monitoring Service

Product Details

You want fast subject recruitment, compliant site performance and reliable data. You need efficient trial monitoring and well prepared clinical trial sites.Monitors are the backbone of your clinical trial. Ethicare monitors:Protect the rights, safety and well-being of your clinical trial subjectsOversee the progress of your clinical trialSupport fast recruitmentEnsure protocol complianceApply SOPs, GCP and applicable regulatory requirementsEnsure accurateness and reliability of clinical dataHelp to increase acceptance of clinical data by the regulatory authoritiesMonitoring is a major cost factor in your clinical trial budget. Investing the money in an efficient monitoring service that considers the priority and complexity of your project without compromising quality is crucial for success. Ethicare helps you to find the right solutions and offers much more for your clinical trial, including:Feasibility studies and concepts Assessments of sites and investigator qualifications Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling) Ethics committee and regulatory authority submissions Investigator Site File compilation and review Translation of study-specific documents including quality check GCP monitoring Site management Study logistics support Support for site audits and inspections/li> Preparation of investigator meetings State-of-the-art study / project management, including risk management Intensive training sessions during investigator meetings (e.g. GCP, safety reporting, IMP handling) Supporting analysis on data quality and timeliness as well as on individual investigational site performance Ethicare Clinical MonitorsEthicare is known for its highly qualified personnel. We continually invest in improving the skills and capabilities of our most important asset – our staff, which includes our clinical monitors. Ethicare clinical monitors have:Appropriate trainingThe scientific and medical knowledge to monitor your trialDocumented evidence of their educational background, their specific qualifications and their extensive experiencesAll Ethicare clinical monitors have received training in GCP, local laws, safety reporting requirements and other relevant areas of their daily work.Building relationships with investigators and site personnel is another important key to your trial's success. The <>Ethicare clinical monitor is trained to significantly influence the site performance (e.g. recruitment, data quality, protocol compliance etc.). Ethicare clinical monitors are dedicated to your clinical trials and will assure constant quality and performance.Monitoring ConcepThe Ethicare monitor's first priority is acting as the main line of communication between the sponsor and the investigator. Considering this, it is obvious that the monitor significantly affects the investigator and site performance. The monitor's knowledge and capabilities strongly influence the timeliness and reliability of data.Motivation concepts for sitesA variety of challenges can occur during the conduct of a clinical trial, such as:Slow patient recruitment Late data reporting Informed consent problems Reported data quality below expectations High number of protocol deviations Records not kept adequate and accurate