Experimental set up, data acquisition & reporting for regulatory genetic toxicology assays

Cyto Study Manager integrates genetox data acquisition, auditing, reporting and study management into a single system. Our GLP compliant solution is revolutionizing genetox study workflows and helping clients to reduce costs, increase efficiencies, and improve regulatory compliance.

Cyto Study Manager is a comprehensive and configurable solution, hosted on your servers or in the cloud, allowing you to manage all your genetox assays from one study management system, thereby increasing data reliability and traceability whilst saving time and resources.

Suitable for:

  • Ames in-vitro assay
  • Comet in-vitro and in-vivo assay
  • Micronucleus in-vitro and in-vivo assay
  • Chromosome Aberrations in-vitro and in-vivo assay
  • Neutral Red Uptake in-vitro assay
  • Any assay that is used to show a dose-response relationship

Features include:

  • Comet, micronucleus, chromosome aberrations & customizable modules
  • Data acquisition from flow cytometers, tally counters, Comet Assay IV & other genetox scoring platforms
  • Automatic, customizable reporting & statistics
  • Flexible study design

 

Highlights

  • Flexible experiment design
  • Reusable experiment & study templates
  • Sample coding & decoding
  • Extensive genetox data collection (from multiple sources and platforms)
  • Effortless data review
  • Straightforward data approval
  • Customizable reporting & statistics
  • Extensive GLP audit trail functionality
  • Excellent user control (delivered by System Access Manager)
  • Comprehensive data archive capability
  • Historical control data management
  • GLP & 21CFR Part 11 compliant

“Cyto Study Manager’s reporting function ensures that data entered into the system is seamlessly exported and converted into statistical reports that cannot be changed once generated. This saves us time and significantly reduces our validation burden. This feature, used within a fully secure and GLP-compliant environment, gives the regulatory authorities full confidence in our processes and reporting.” Study Director, Global Pharmaceutical Company

Key Benefits

Improves workflows - Around the world, Cyto Study Manager is replacing multiple genetox systems with one comprehensive, easy to use solution. Cyto Study Manager combines experimental set up, data collection and automatic report generation, which saves you time and streamlines your genetox workflows!

Get results sooner - We are helping clients reduce paperwork and get the answers they need faster than ever before. Study templates allow you to copy previous study designs, so you don’t need to  re-configuring, re-type or re-enter setup information. Integrated data collection and reporting means you can report on your data as soon as it is collected, helping you interpret results faster.

Flexible study design - Our solution is designed to work with the regulatory Genetox assays, including ames, comet, micronucleus chromosome aberrations and NRU. Cyto Study Manager can also be configured to work with any other Genetox assay that shows a dose-response relationship, ensuring we can meet your specific Genetox needs. Experiments can have multiple stages, multiple test items, several or no control groups! Cyto Study Manager can deal with your unique experimental set-up, whatever that might be.

Ensures compliance & increases data traceability - All actions that are carried out within Cyto Study Manager, such as creating, editing and deleting data, are recorded within an audit trail. Cyto Study Manager has been designed with reference to the OECD and S2(R1) guidelines. It is fully compliant with the principles of Good Laboratory Practice (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.

Increases productivity within your Genetox team - Access Cyto Study Manager anytime, anywhere! Our solution is a secure, web-based system; you can log in from anywhere using the standard version of Google Chrome.Multiple users can log in simultaneously - each can be working on the same or different experiments.

Produces customized reports & statistics automatically - Reports are generated securely and automatically from within the system. Available reports include sample coding/decoding information, results tables, historical data ranges and audit information. Reports can easily be customized to match your own corporate style and data interpretation needs. Because all of this is achieved within one system, there is no risk of transcription errors, no import/export, no file transfers and no copy and paste, saving you time and reducing errors.

Removes experimental bias - When scoring your Genetox assay, Cyto Study Manager can present the scorer with a list of coded samples to remove scorer bias. Coded samples are configurable and can be any letter-number combination you need. The sample details are handled invisibly by Cyto Study Manager and the scorer remains “blind” to all experimental information. Cyto Study Manager stores data against the appropriate sample automatically, so study directors can review, approve, and reject data in real time.

You work to GLP and so do our genetox solutions…

All of Instem’s genetox solutions are designed with reference to the OECD and S2(R1) guidelines. We ensure our solutions are fully compliant with the principles of Good Laboratory Practice (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.

Regulatory Compliance Cyto Study Manager

Fact Sheet

CSM Case Study

Fact Sheet

CSM Case Study

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