Cyto Study Manager

Cyto Study Manager is a comprehensive platform designed to streamline genetic toxicology workflows by integrating data acquisition, auditing, reporting, and study management into a single, cohesive system. It is GLP-compliant and helps researchers reduce costs, eliminate transcription errors, and confidently meet regulatory requirements.

This platform is tailored for the analysis and reporting of genotoxicity assays, integrating data from various assay types such as comet and transgenic rodent assays. It simplifies the management of complex studies by centralizing data, enhancing traceability, and supporting regulatory compliance.

Cyto Study Manager offers several key benefits:

• Saves Time: Accelerates study timelines by eliminating manual entry and repetitive setup through preconfigured templates and automated data capture.
• Improved Compliance: Simplifies regulatory compliance with built-in audit trails, electronic signatures, and alignment with GLP and 21 CFR Part 11 standards.
• Enhanced Customization: Modules can be tailored to support any in vivo or in vitro assay, allowing for flexible experimental designs.
• Greater Study Integrity: Coded sample presentation prevents scorer bias, ensuring objectivity and consistency.

The platform supports a wide range of genotoxicity assays, including Ames Assay, Comet Assay, Micronucleus, Chromosome Aberrations, Neutral Red Uptake, and Transgenic Rodent assays. It offers features like automated plate counts, real-time comet scoring, and configurable plate layouts to support regulatory compliance and accelerate assay setup.

Cyto Study Manager is designed to integrate seamlessly into existing lab workflows, covering the entire study lifecycle from treatment group setup to automated reporting. Developed with reference to OECD and S2(R1) guidelines, it aligns with GLP and 21 CFR Part 11 standards, providing validation support to help researchers launch their studies confidently.

A case study highlights its effectiveness: A European pharmaceutical company faced challenges with disconnected systems and manual data entry. By adopting Cyto Study Manager, they achieved seamless integration with their image analysis tools, supporting both comet and micronucleus assays efficiently.