Red Thread Script™ | Automating Bioanalytical Data Compilation with Precision

Built by Bioanalysts, for Bioanalysts.

Red Thread Script™ | Automating Bioanalytical Data Compilation with Precision

Built by Bioanalysts, for Bioanalysts.

Molecular assays are essential to bioanalysis, but inconsistent practices, non-prescriptive regulatory guidance, and a lack of standardized protocols create variability in execution and validation. At the same time, the high volume and complexity of raw data make manual transcription and tabulation, error-prone and inefficient, slowing QC/QA review, risking data integrity, and straining compliance with regulatory timelines.

Red Thread Script, part of the Red Thread solution, automates tabulation of data from raw data obtained from instruments, performs critical statistical calculations such as mean and %CV, while applying user-defined acceptance criteria to annotate results with consistency and accuracy. It also derives best-fit line equations and enables real-time, interactive data interpolation, supporting objective decision-making and minimizing reliance on manual interpretation.

Fully validated, Red Thread Script provides interim data checks that streamline review processes for both Quality Control (QC) and Quality Assurance (QA) teams by eliminating the need for interim QC checks.

Learn how Red Thread can help you

SCHEDULE A DEMO

The Red Thread Script Advantage: Efficiency, Accuracy, Error Reduction, and Enhanced Customization with Flexibility

Increased Efficiency and Throughput: Automated data processing reduces time spent on manual tasks by over 90%, enabling faster turnaround, improved workload management, and streamlined collaboration. More importantly, the validated software allows saving the interim QC / QA post-data transcription and prior to stats analysis and data annotation.

Improved Accuracy and Error Reduction: By eliminating manual transcription and calculations, Red Thread Script minimizes errors and ensures consistent, high-quality data output ready for regulatory review.

Enhanced Regulatory Compliance and Oversight: Built with input from industry experts, the software supports GxP and 21 CFR Part 11 compliance, complete with audit trails and validated workflows aligned with FDA and EMA expectations and industry best practices (since there aren’t many regulatory guidelines).

Flexibility and Control: In the absence of prescriptive guidance, Red Thread Script offers configurable acceptance criteria and supports evolving industry standards all while maintaining secure, remote access via a cloud-based platform.

Red Thread is designed by experts to meet the highest standards of bioanalytical rigor. It’s ISO 27001 certified, SOC 2 Type 2 attested, fully validated, and compliant with 21 CFR Part 11, FDA, and EMA guidelines.

The Red Thread Script Advantage: Efficiency, Accuracy, Error Reduction, and Enhanced Customization with Flexibility

Increased Efficiency and Throughput: Automated data processing reduces time spent on manual tasks by over 90%, enabling faster turnaround, improved workload management, and streamlined collaboration. More importantly, the validated software allows saving the interim QC / QA post-data transcription and prior to stats analysis and data annotation.

Improved Accuracy and Error Reduction: By eliminating manual transcription and calculations, Red Thread Script minimizes errors and ensures consistent, high-quality data output ready for regulatory review.

Enhanced Regulatory Compliance and Oversight: Built with input from industry experts, the software supports GxP and 21 CFR Part 11 compliance, complete with audit trails and validated workflows aligned with FDA and EMA expectations and industry best practices (since there aren’t many regulatory guidelines).

Flexibility and Control: In the absence of prescriptive guidance, Red Thread Script offers configurable acceptance criteria and supports evolving industry standards all while maintaining secure, remote access via a cloud-based platform.

Red Thread is designed by experts to meet the highest standards of bioanalytical rigor. It’s ISO 27001 certified, SOC 2 Type 2 attested, fully validated, and compliant with 21 CFR Part 11, FDA, and EMA guidelines.

Red Thread Script for qPCR Sample Analysis Data:
Features & Functionalities

Tabulation: Automates data transcription and tabulation of qPCR raw data into five reportable data tables: Regression, Negative Target Control, Calibration Standard Samples, QC samples, True Unknown Sample

Essential Statistical Analysis: Basic statistical analysis, such as calculation of mean, %CV, and more

Annotation: Data annotation based on acceptance criteria are specified in user inputs and tracked in audit trails for enhanced compliance

Interactive, Real-time Data Interpolation: Red Thread derives a linear regression equation that allows for inclusion or exclusion of critical data points for objective decision making through interactive data interpolation in real-time

How Red Thread Script Delivers Value Through Bioanalytical Automation

12x

ROI

Through time and cost savings, increased throughput

99%

TIME SAVINGS

Time savings resulting from automation of data compilation and review can enhance turnaround times and improve resource management

99%

COST SAVINGS

Better allocate your human resources to critical decision-making and troubleshooting tasks

Submission-ready data + Reduction in transcription and calculation errors + Increased throughput

Automation of manual, error-prone, bias-prone tasks brings consistency and results in accurate data that is regulatory submission ready as well as improved resource allocation toward tasks that generate revenue

Resource for Red Thread Script for qPCR

Can Automation Improve Compliance, Consistency, & Efficiency for CGTP Data Analysis?

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.

Contact us today and let us know what challenges you are facing.

Frequently Asked Questions about Red Thread Script Security, Validation, & Data Input/Output

Is Red Thread Script secure and/or validated?

Yes, Red Thread Script is validated, and BioData can provide Operational Qualification / Performance Qualification for user validation. To ensure the security of your data, Red Thread is ISO 27001 certified and SOC 2 Type 2 attested. Red Thread complies with 21 CFR Part 11, CSV, GxP, FDA, and EMA regulations, and GDPR. Red Thread provides access control, audit trails, data encryption, and numerous other features to ensure your data remains secure.

What are the input and output files required for Red Thread Script?

The input file is directly exported from QuantStudio. The output file is an Excel file containing data tables, inclusive of basic statistical analysis performed on the data, annotations made to the data based on the acceptance criteria submitted, and the data from interactive interpolation for calibration standards and regression.

If I’m interested in Script or other Red Thread modules, how can I get in touch?

Schedule a demo or connect with a Red Thread specialist to explore solutions tailored to your lab.

Red Thread: An End-to-End Bioanalytical Solution for Regulatory Compliance

Red Thread is designed to meet the needs of various components across the bioanalytical lifecycle process.

Bioanalytical Method Validation with Red Thread Script

Method Development
Fit
Regression Optimization
Verge
Cut Point Analysis

Method Validation
Fit
Regression Optimization
Verge
Cut Point Analysis

Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Red Thread: An End-to-End Bioanalytical Solution for CMS and Ligand Binding Validation Assays

Red Thread is designed to meet the needs of various components across the bioanalytical lifecycle process.

Bioanalytical Method Validation with Red Thread Fit

Method Development
Fit
Regression Optimization
Verge
Cut Point Analysis

Method Validation
Fit
Regression Optimization
Verge
Cut Point Analysis

Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Bioanalytical Sample Analysis with Red Thread Script

Sample Preparation & Analysis
Fit
Regression Optimization
Verge
Cut Point Analysis

Interim Data Release
Eval – PK
PK Audit
(in development)
Verge
Cut Point Analysis

Database Lock & Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Bioanalytical Sample Analysis with Red Thread Script

Sample Preparation & Analysis
Fit
Regression Optimization
Verge
Cut Point Analysis

Interim Data Release
Eval – PK
PK Audit
(in development)
Verge
Cut Point Analysis

Database Lock & Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

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.

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.

red-thread-script-bioanalytical-data-compilation

Red Thread Script™ | Automating Bioanalytical Data Compilation with Precision

Built by Bioanalysts, for Bioanalysts.

Red Thread Script™ | Automating Bioanalytical Data Compilation with Precision

Built by Bioanalysts, for Bioanalysts.

Fully validated, Red Thread Script provides interim data checks that streamline review processes for both Quality Control (QC) and Quality Assurance (QA) teams by eliminating the need for interim QC checks.

Learn how Red Thread can help you

The Red Thread Script Advantage: Efficiency, Accuracy, Error Reduction, and Enhanced Customization with Flexibility

Improved Accuracy and Error Reduction: By eliminating manual transcription and calculations, Red Thread Script minimizes errors and ensures consistent, high-quality data output ready for regulatory review.

Flexibility and Control: In the absence of prescriptive guidance, Red Thread Script offers configurable acceptance criteria and supports evolving industry standards all while maintaining secure, remote access via a cloud-based platform.

Red Thread is designed by experts to meet the highest standards of bioanalytical rigor. It’s ISO 27001 certified, SOC 2 Type 2 attested, fully validated, and compliant with 21 CFR Part 11, FDA, and EMA guidelines.

The Red Thread Script Advantage: Efficiency, Accuracy, Error Reduction, and Enhanced Customization with Flexibility

Improved Accuracy and Error Reduction: By eliminating manual transcription and calculations, Red Thread Script minimizes errors and ensures consistent, high-quality data output ready for regulatory review.

Flexibility and Control: In the absence of prescriptive guidance, Red Thread Script offers configurable acceptance criteria and supports evolving industry standards all while maintaining secure, remote access via a cloud-based platform.

Red Thread is designed by experts to meet the highest standards of bioanalytical rigor. It’s ISO 27001 certified, SOC 2 Type 2 attested, fully validated, and compliant with 21 CFR Part 11, FDA, and EMA guidelines.

Red Thread Script for qPCR Sample Analysis Data: Features & Functionalities

Tabulation: Automates data transcription and tabulation of qPCR raw data into five reportable data tables: Regression, Negative Target Control, Calibration Standard Samples, QC samples, True Unknown Sample

Essential Statistical Analysis: Basic statistical analysis, such as calculation of mean, %CV, and more

Annotation: Data annotation based on acceptance criteria are specified in user inputs and tracked in audit trails for enhanced compliance

Interactive, Real-time Data Interpolation: Red Thread derives a linear regression equation that allows for inclusion or exclusion of critical data points for objective decision making through interactive data interpolation in real-time

How Red Thread Script Delivers Value Through Bioanalytical Automation

12x

ROI

99%

TIME SAVINGS

99%

COST SAVINGS

Submission-ready data + Reduction in transcription and calculation errors + Increased throughput

Resource for Red Thread Script for qPCR

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.

Contact us today and let us know what challenges you are facing.

Frequently Asked Questions about Red Thread Script Security, Validation, & Data Input/Output

Is Red Thread Script secure and/or validated?

What are the input and output files required for Red Thread Script?

If I’m interested in Script or other Red Thread modules, how can I get in touch?

Red Thread: An End-to-End Bioanalytical Solution for Regulatory Compliance

Red Thread is designed to meet the needs of various components across the bioanalytical lifecycle process.

Bioanalytical Method Validation with Red Thread Script

Method Development Fit Regression Optimization Verge Cut Point Analysis

Method Validation Fit Regression Optimization Verge Cut Point Analysis

Data Analysis Eval – PK PK Audit (in development)

Report Writing Script – qPCR qPCR Table Compilation

Data Auditing Eval – PK PK Audit (in development)

Red Thread: An End-to-End Bioanalytical Solution for CMS and Ligand Binding Validation Assays

Red Thread is designed to meet the needs of various components across the bioanalytical lifecycle process.

Bioanalytical Method Validation with Red Thread Fit

Method Development Fit Regression Optimization Verge Cut Point Analysis

Method Validation Fit Regression Optimization Verge Cut Point Analysis

Data Analysis Eval – PK PK Audit (in development)

Report Writing Script – qPCR qPCR Table Compilation

Data Auditing Eval – PK PK Audit (in development)

Bioanalytical Sample Analysis with Red Thread Script

Sample Preparation & Analysis Fit Regression Optimization Verge Cut Point Analysis

Interim Data Release Eval – PK PK Audit (in development) Verge Cut Point Analysis

Database Lock & Data Analysis Eval – PK PK Audit (in development)

Report Writing Script – qPCR qPCR Table Compilation

Data Auditing Eval – PK PK Audit (in development)

Bioanalytical Sample Analysis with Red Thread Script

Sample Preparation & Analysis Fit Regression Optimization Verge Cut Point Analysis

Interim Data Release Eval – PK PK Audit (in development) Verge Cut Point Analysis

Database Lock & Data Analysis Eval – PK PK Audit (in development)

Report Writing Script – qPCR qPCR Table Compilation

Data Auditing Eval – PK PK Audit (in development)

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.

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.

Red Thread Script for qPCR Sample Analysis Data:
Features & Functionalities

Method Development
Fit
Regression Optimization
Verge
Cut Point Analysis

Method Validation
Fit
Regression Optimization
Verge
Cut Point Analysis

Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Method Development
Fit
Regression Optimization
Verge
Cut Point Analysis

Method Validation
Fit
Regression Optimization
Verge
Cut Point Analysis

Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Sample Preparation & Analysis
Fit
Regression Optimization
Verge
Cut Point Analysis

Interim Data Release
Eval – PK
PK Audit
(in development)
Verge
Cut Point Analysis

Database Lock & Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)

Sample Preparation & Analysis
Fit
Regression Optimization
Verge
Cut Point Analysis

Interim Data Release
Eval – PK
PK Audit
(in development)
Verge
Cut Point Analysis

Database Lock & Data Analysis
Eval – PK
PK Audit
(in development)

Report Writing
Script – qPCR
qPCR Table Compilation

Data Auditing
Eval – PK
PK Audit
(in development)