A monitoring solution wouldn’t be complete without the tools that clinical research associates (CRAs) need to efficiently manage site monitoring activities and create visit reports.
Medidata’s cloud-based on-site monitoring module is integrated with EDC—providing smart workflows and structured visit reports that pull data directly from EDC to save CRAs time and improve the quality of data and documents.
According to CenterWatch, today’s CRAs manage an average of 3.5 active Phase II-III protocols and 8.9 active investigative sites at the same time. Without the latest technology, managing sites can be a burden on your CRAs—their time is wasted on redundant tasks and duplicated efforts, such as formatting documents or copying and pasting between systems. This can lengthen cycle times and inadvertently introduce errors. Poor data quality impacts not only your study; it also hinders site investigators and frustrates the CRAs responsible for managing heavy workloads.
Medidata’s pre-built and pre-validated EDC-CTMS integration allows data to flow directly between the two systems. The systems work together behind the scenes to trigger events automatically and auto-populate data, eliminating redundant data entry and transcription errors. This makes managing monitoring activities simple.
CRAs record their site visit activities in an intuitive questionnaire—which can be configured specifically for each study. Rather than entering source document verification (SDV) work in both an EDC system and CTMS, they enter it only once into EDC and it gets captured in both systems automatically. Action items are structured too, so all information documented by the CRA during their site visit is automatically formatted into standardized trip reports and site correspondences. The smart workflows make it simple and quick for reviewers to comment, approve and e-sign visit reports too.
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Cloud-based system that offers easy-to-consume enhancements on a regular basis to power your study operations