Release 4.19 brings a rebuilt eCRF and randomisation with RTSM: block and dynamic allocation, and the supply side that follows.
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Designing digital consent, rolling it out to sites, and meeting the regulatory requirements along the way.
BYOD collection, patient compliance and EDC integration, and what pushes teams off paper questionnaires.
Digitising trial workflows to collect data securely, protect privacy and cut the cost of running a study.
What each tool owns, how the three fit together, and the analytics you get once they share data.
How random allocation prevents selection bias, with simple, block, stratified and adaptive methods compared.
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A five-step selection method, criteria by study type, and the questions to put to vendors.
Tracking sites and milestones, automating workflows and centralising reporting across a study.
Validation rules, risk-based monitoring and audit trails, and the effect on cleaning time.
From structure and edit checks to usability, the steps that cut errors and speed up monitoring.
Audit trails, compliance and security compared, and the risk a spreadsheet carries into a study.
Running post-market surveillance studies under EU MDR: data capture, evidence generation and reporting.