Quality Assured

Red Thread™ by Ariadne Software

A powerful combination of quality assurance and scientific oversight at your fingertips

Red Thread™, an Ariadne product, is an industry pioneer in assuring bioanalytical data integrity and quality. This is a specialized solution that not only automates the time-intensive data review process; it applies advanced computational techniques to detect trends of importance or potential compliance issues. Red Thread’s algorithms offer a level of sensitivity not possible before.

Red Thread™ provides an early warning system by monitoring bioanalytical data sets across a clinical study or an entire program. Three levels categorize risk by severity of impact to your drug development program. All data are reviewed, and quality issues are flagged through clear indicators:

The yellow flag feature is fundamentally different than what any other quality control solution offers, by giving you a clear indicator of assay robustness and longevity. For example, in situations where your assay passes incurred sample reanalysis (ISR) above threshold at 70%, there still may be latent trends which need further exploration.  Red Thread™ identifies recurring failures and helps the user identify root causes of these events. Additionally, Red Thread™ will also identify near-failure patterns, which are not only challenging to identify, but often pose the greatest threat to a project.  Borderline passing performance trends typically indicate underlying larger problems, which left undetected, can present high risk for a development program in later stages.

Red Thread™ is a powerful tool for providing objectivity and rigor, complementing existing data review and quality control processes.

Red Thread™ delivers unprecedented efficiencies by dramatically reducing the amount of time required for data review and regulatory inspection preparation. It extracts all reviewable data, in virtually every format – from raw data to finalized clinical study reports, and tags failing and near-failing data points. Once data are extracted, they can be analyzed by standard and best practice criteria, or custom criteria chosen by you.

Red Thread’s capabilities will be constantly improved and refined as specific issues of importance are identified. Specificity, sensitivity and overall precision are increased after each use.

With a depth of analytical computing power, Red Thread™ helps sponsors build a complete bioanalytical profile, while rapidly identifying assay-related problems at the earliest stages of clinical development, before potential risks escalate into liabilities.