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CLINICAL OPERATIONS
Medicorent provides experienced team to plan, design and manage your clinical study from start to end. Whether you need help with standalone services such as feasibilities studies, regulatory submissions, site management and monitoring, or all of the above, we have the expertise to set you up for success by getting it right from the start.
CLINICAL START UP STUDY
Clinical study start-up is a complex and highly regulated part of a clinical trial involving several stakeholders (sponsor, site, regulatory authorities etc.). Study start-up includes many milestones starting with feasibility and ending with the enrollment of the first subject, with several activities in-between such as site selection, pre-study visit, regulatory submissions, site contract and budget negotiation, vendor set-up, and site initiation.
REGULATORY SUBMISSIONS
Regulatory submissions are critical milestones during study start-up and the outcome has a substantial impact on the timelines and conduct of the entire clinical study. Submission requirements vary between countries and the quality of submission packages can influence approval timelines. Changes are inevitable in clinical studies and these changes may require additional submissions (i.e., amendments) before implementation can take place.
CA and EC submissions
Streamline regulatory submissions
Medicorent’s knowledge of local requirements for regulatory submissions and our focus on proactive planning and efficient communication are key to speeding up the submissions process and reducing timelines. Let us support you with your regulatory submissions during the entire clinical study period, from start-up to close-out.
· Compiling submission packages
· Ethics Committee (EC) submission
· Competent Authority (CA) submission
· Country-specific submissions (biobank, radiation committee, etc.)
· Reporting in EudraCT
· Interpretation of regulatory requirements
CLINICAL MONITORING AND SITE MANAGMENT
Adequate clinical monitoring of trials is imperative and guarantees the subjects’ rights and welfare, data quality, and regulatory compliance. Medicorent has experience in a wide range of therapeutic areas and can offer fit-for-purpose monitoring services for all phases of clinical trials.
Clinical monitoring, a monitor’s pivotal role
At Medicorent, we understand the importance of a strong collaboration between the study sites and our monitors, and the crucial impact it has on the progress and quality of the study. That’s why Medicorent’s Clinical Research Associates (CRAs) are dedicated to fostering a good working relationship with each site, motivating them every step of the way and supporting them in any way possible. CRAs play the pivotal role of training study personnel, performing on-site visits and remote monitoring, as well as reviewing patient enrollment, study documentation, data and more.
· On-site monitoring visits including site initiation, routine monitoring visits, and close-out.
· Risk-based monitoring
· Monitoring plan
· Source data verification
· Query resolution
· Drug accountability
· Site training and support
· Co-monitoring
· Site management support and documentation
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