Identify Unblinding Risks

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Identify Unblinding Risks

Every clinical trial runs the risk of unintentional unblinding.With 30 years of experience designing reliable RTSM solutions, Calyx IRT is the solution you can rely on to identify and minimize these risks.

Learn how Calyx’s processes drive the integrity of your trial by keeping unblinding risks to the minimum through

Tailored Risk Management Per Study and Per Protocol

The Calyx IRT team begins with a review of a library of 200+ clinical trial risks, including unintentional unblinding, to weigh and mitigate those for each study
Every data point entered in and provided by IRT for the study is assessed, identifying whether each could fully or partially unblind alone or in combination
Calyx understands from the sponsor which roles are permitted to know what data
The team of SMEs will review protocol, packaging, and study-specific risks on an ongoing basis, reviewing mitigating actions and evaluating any changes.

研究管理

Every study report of every type created for a study is assigned a blinding status appropriate for its content
Automated system checks prevent blinded recipients from viewing unblinding reports

Live Study Management

Ad hoc data transfers e.g., mid-study, follow robust SOPs
All data points included in ad hoc transfers are assessed against blinding status and recipients
A communication plan is agreed per study before Go Liveand amended as needed
Communication from Calyx 24/7 Service Desk includes unblinding word checks to ensure they do not contain information that could cause unblinding