Monitoring is a crucial cornerstone for the validity of your study data and integrity of your study results.
Our focus is to verify the 3 GCP pillars:
- The rights and well-being of human subjects are protected
- The reported trial data are accurate, complete, and verifiable from source documents
- The conduct of the clinical study is in compliance with the currently approved protocol, with GCP, and with the applicable regulatory requirement(s).
Our team of monitors is experienced with medical or scientific background working for several years on different therapeutic areas.
Our global network of monitors allow us to perform monitoring visits in many countries in Europe, MENA region, Asia and Africa.
Our approach is flexible and depends on Protocol and study phase needs. Our partners could develop a systematic or risk-based approach to monitoring of their clinical study. Our partners may choose on-site or remote monitoring, or a combination of on-site and remote monitoring.
What We Do?
- Monitoring Plan
- Support in site nomination through our sites' database across different therapeutic area & regions
- Performing site qualification/selection visits
- Performing site initiation visits (SIV) and timely activation of investigational sites
- Conducting monitoring visits (on-site or remote) with high-quality data verification and reporting
- Close-Out Visits (COV) can also be handled by easyClinical team
- Effective interaction with sponsor and investigative teams
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Capabilities
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Benefits
At easyClinical we leverage data management systems to ensure that patient data is collected in real-time through eCRF, reducing the risk of data entry errors.
We encourage continuous monitoring to identify discrepancies, missing data, or protocol deviations early on.
We use automated data verification processes to ensure that the information is accurate and reliable before it's used for decision-making.
We provide our partners with predictive analytics tools and study metrics to optimize patient enrollment, detect issues in patient data that might indicate adverse events, thus enabling quicker responses, ultimately leading to better decision-making and faster trial completion.
Effective data monitoring leads to short trial timelines and low study costs. At easyClinical we ensure that for each monitoring visit done, the likelihood of study outcomes release is increased.
Insights
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