Red Thread® is BioData’s premier software, powered with advanced computational techniques and artificial intelligence technologies to automate bioanalytical processes.
Compliant with FDA and EMA guidances and best practices, the Red Thread solution enables biopharma to build a complete bioanalytical profile at the earliest stages of drug development. Each module—Verge, Fit, Script, and Eval—targets a specific point in ADA, qPCR, or PK workflows and models, enabling faster, more consistent, and regulatory-submission-ready results.
Precision
Red Thread delivers objectivity and rigor to bioanalytical data processing, analysis and review. It automates time-intensive manual, repetitive, subjective, and error-prone processes. Virtually every format, from raw data to finalized study report is supported by Red Thread.
Speed
Advanced computational technologies and artificial intelligence provide rapid and efficient data analysis and review, with the ability to quickly detect trends of importance, or potential compliance issues. Red Thread dramatically reduces time-consuming tasks for scientific staff. High-volume bioanalytical data processing can be completed in minutes, not days.
Depth
High sensitivity analysis offers granularity that goes way beyond failure identification. Red Thread helps users find root causes and identify near-failure patterns, often the source of longer-term threats to drug development integrity.
Visualization
Red Thread presents analytics in clear graphical formats, making it easier to grasp complex concepts and identify meaningful patterns. Data is flagged as green (compliant), red (non-compliant), or yellow (requiring further review), helping decision makers quickly assess results and focus on areas that need attention.
Built by bioanalysts for bioanalysts, Red Thread is designed by experts to meet the highest standards of bioanalytical rigor. It is ISO 27001 certified, SOC 2 Type 2 attested, fully validated, and compliant with 21 CFR Part 11, as well as FDA and EMA guidelines.
Learn how Red Thread can help you
Red Thread Modules: Purpose-built automation tools accelerating bioanalytical workflows
The Red Thread solution is made up of four different modules, customizable to specific workflows and platform-agnostic.
CUT POINT
Red Thread Verge™: Automated ADA Statistical Analysis for Cut Point, Sensitivity, and low positive control (LPC)
REGRESSION
Red Thread Fit™: Automated Curve Fitting for Small and Large Molecules Calibration Curves
TABLE COMPILATION
Red Thread SCRIPT™ for qPCR: Automating Bioanalytical Data Compilation with Precision
AUDIT
Red Thread Eval™ for PK Data Audit: Automated Scientific Review and Audit of PK Data for small and large molecules
Contact us today and let us know what challenges you are facing.
How does Red Thread work?
Red Thread follows a simple 3-step process and provides results within minutes to bioanalysts. For a more in-depth explanation, reach out to us to speak with one of our experienced analysts and see a demo of our product.
Frequently Asked Questions about Red Thread Fit and PK Assay Automation
Is Red Thread compatible with all systems?
The system is compatible with all major file types and operating systems. You can use it across different devices and platforms without compatibility issues.
Can I access the system remotely?
Yes, the system is cloud-based, allowing secure access from anywhere at any time via the internet.
What compliance standards does the system meet?
The system complies with multiple industry and regulatory standards, including:
- 21 CFR Part 11
- Computer System Validation (CSV)
- ISO 27001
- SOC 2 Type 2
- GDPR
- GxP
- FDA/EMA regulations
How is data integrity maintained?
The platform is a validated system designed to ensure data integrity, meaning that all data is accurate, consistent, and safeguarded against unauthorized changes.
How is AI used in achieving successful outcomes for bioanalysis?
The system utilizes AI models for extracting and parsing input data within certain software modules to overcome challenges that come along with differences in file, reporting, and naming formats.
Streamline Your Bioanalysis Workflows with Red Thread: See It in Action Today
Schedule a demo or connect with a Red Thread specialist to explore solutions tailored to your lab
BioData Solutions: Making a Global Impact in Pharmaceutical Development
Since 2015, BioData Solutions has been committed to make an impact in the bioanalytical drug development field by providing consulting and software solutions globally.We continually aim to promote data quality, regulatory compliance, efficiencies, and vital thought leadership.
