Cyto Study Manager™

Smarter Genetox Starts Here

Cyto Study Manager is a centralized, GLP-compliant platform that streamlines genetic toxicology workflows by integrating data acquisition, auditing, reporting, and study management into one cohesive system. It helps researchers reduce costs, eliminate transcription errors, and meet regulatory requirements with confidence.

Remove risk, enhance traceability, and accelerate your studies with a solution built for efficiency and compliance. Request your Cyto Study Manager demo today!

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What is Cyto Study Manager?

Cyto Study Manager is a powerful, modular platform designed for the analysis and reporting of genotoxicity assays. It streamlines the management of genotoxic studies by integrating data from various assay types, including comet and transgenic rodent assays. Cyto Study Manager goes beyond data capture by making it easier to review and approve data, simplifying auditing, and supporting regulatory compliance.

Genotoxicity studies are essential for preclinical research, offering critical insights into drug safety. However, managing complex studies and large sets of diverse data from different assays can be challenging, potentially leading to disorganized or misplaced datasets and wasted effort.

Cyto Study Manager ensures that all study data, regardless of source, is centralized, traceable, and easy to manage. With customizable templates, built-in audit trails, and seamless integration with lab equipment, the platform reduces manual effort, minimizes errors, and accelerates study timelines.

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Key Benefits of Cyto Study Manager

Saves Time

Cyto Study Manager accelerates study timelines by eliminating manual entry and repetitive setup through preconfigured templates and automated data capture. Its seamless integration with lab equipment and broad assay support ensures efficient, consistent, and reproducible workflows.

Improved Compliance

Cyto Study Manager simplifies regulatory compliance and strengthens data integrity with built-in audit trails, electronic signatures, and complete alignment with GLP and 21 CFR Part 11 standards.

Enhanced Customization

Cyto Study Manager modules can be tailored to support any in vivo or in vitro assay that captures a dose-response relationship. Users can customize experimental designs with any number of data collection stages and endpoints, ensuring flexibility and broad applicability across study types.

Greater Study Integrity

Coded sample presentation helps prevent scorer bias during manual assessments, while centralized data management ensures objectivity and consistency throughout the study process.

Core Features/Modules

Cyto Study Manager supports a wide range of genotoxicity assays and is fully customizable, with the following being some of the most commonly used.

Ames Assay In Vitro

Cyto Study Manager offers the Sorcerer Colony Counter module to automatically capture plate counts and observations, reducing transcription errors and accelerating data collection.

Comet Assay In Vitro and In Vivo

The platform enables real-time comet scoring via the Comet Assay IV module or direct data import from third-party tools, enabling flexible and efficient analysis.

Micronucleus In Vitro and In Vivo

Cyto Study Manager supports manual entry, tally counters, and data imports from flow cytometry or other automated scoring platforms, offering flexibility while ensuring consistent data capture.

Chromosome Aberrations In Vitro and In Vivo

The platform lets researchers replace paper-based scoring with direct data entry or electronic counters.

Neutral Red Uptake In Vitro

Cyto Study Manager offers configurable plate layouts, with built-in OECD and Health Canada formats, to support regulatory compliance and accelerate assay setup.

Transgenic Rodent (MutaMouse and Big Blue)

Track DNA packaging events effortlessly with a system that flags out-of-range values based on set criteria, simplifying data review and enhancing throughput and accuracy.

Why Choose Cyto Study Manager?

Cyto Study Manager is a unified platform designed to streamline the management of genotoxicity studies, which often involve complex data and workflow challenges in preclinical research. It offers the flexibility to support various assays while ensuring data integrity and regulatory compliance.

Unlike fragmented solutions that require the purchase of individual support for single assays or rely on error-prone manual entry, Cyto Study Manager integrates seamlessly into existing lab workflows, enabling efficient data collection across diverse assays without compromising speed or quality. The platform covers the entire study lifecycle, from treatment group setup to automated reporting, with built-in audit trails for compliance readiness.

Developed with reference to OECD and S2(R1) guidelines, and aligned with GLP and 21 CFR Part 11 standards, this solution comes with validation support from Instem to help researchers launch confidently and quickly.

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Customer Success Stories

A leading European pharmaceutical company faced challenges managing genetic toxicology studies using multiple disconnected systems. Manual data entry, complex Excel workbooks, and reliance on a separate statistics team led to inefficiencies, errors, and delays. They needed a GLP-compliant solution that integrated with their existing image analysis system (Metafer4/Relosys4).

The Solution:
The company selected Cyto Study Manager as a unified platform for their genotoxicity studies. The platform’s flexibility facilitated seamless integration with their image analysis tools and supported both comet and micronucleus assays within one system.

The Results:

Efficiency – Manual effort was reduced, and study timelines were significantly shortened.
Data Quality – The evaluation process was standardized, minimizing errors and reducing validation time.
Compliance – The system ensured full GLP and FDA 21 CFR Part 11 compliance, including audit trails and electronic signatures.
Integration – Existing lab tools were seamlessly integrated, enabling automated, consolidated reporting.

Technical Specifications

Deployment options	Software as a service (SaaS) hosted
Licensing Models	Flexible, Cost-Effective, Supports Subscription Models
Compliance Standards	GLP, OECD, S2(R1), and FDA 21 CFR Part 11
Supported File Formats	Support for CVS & txt file imports
Security Features	Standardized security models and controlled access
Scalability	Single-user to organization-wide deployment options

How It Works

Cyto Study Manager streamlines genetic toxicology workflows by guiding researchers through study setup, data collection, review, reporting, and compliance with full traceability and integrated statistical analysis.

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Treatment Group Setup

Define groups, replicates, and dosing schemes to match your study design.

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Experimental Information

Record key details such as test items, methodologies, and protocols.

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Sample Coding/Decoding

Optional coding tools help manage blind scoring and reduce bias.

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Data Collection and Scoring

Enter data manually or import from integrated lab instruments.

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Data Review

Streamline validation with built-in approval workflows and secure data archiving.

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Reporting and Statistics

Generate customizable reports with tables, graphs, and statistical analyses.

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Audit Information

Maintain a complete audit trail for every action to support compliance.

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Frequently Asked Questions

Cyto Study Manager is a comprehensive, all-in-one solution comprising modular components to support genotoxicity studies. Below are some of the most common questions we receive about how it helps address research challenges and integrates seamlessly into existing workflows.

Is Cyto Study Manager cloud-based or on-premise?

It’s available as a cloud-hosted solution, giving you flexibility based on your IT infrastructure and regulatory requirements.

How is data security and user access managed?

User roles, permissions, and password policies are managed through a secure access system, with all actions logged in an encoded audit trail.

Is the platform compliant with regulatory standards?

Yes, it is fully compliant with GLP, OECD, S2(R1), and FDA 21 CFR Part 11 requirements, including audit trails and electronic signatures.

Can I generate complete study reports directly from the platform?

Yes, reports are generated in Microsoft Word format and include results, stats, graphs, audit details, and historical control data, so no copy-pasting is required.

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Cyto Study Manager centralizes genotoxicity workflows into a single platform, helping research teams improve consistency, ensure compliance, and operate more efficiently. It reduces regulatory risks and data entry errors while offering a stronger return on investment compared to managing multiple, module-specific tools or manual processes.

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