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Cyto Study Manager

Data acquisition and reporting for genetic toxicology assays

  • Experiment design
  • Sample coding and decoding
  • Data acquisition, review and approval
  • Reporting, statistics and historical controls
  • Comet assay, micronucleus, chromosome aberrations
  • Comprehensive auditing and archiving
  • GLP & 21CFR compliance
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Overview

Cyto Study Manager integrates data acquisition, auditing, reporting and study management into a single system. 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.

Testimonial

“Really excellent – just what the industry needs.” Study director, global pharmaceutical company

Screenshots

How it works

Flexible study designs

Cyto Study Manager lets you perform studies on multiple test items, each of which can be used in any number of experiments. Both in vivo and in vitro experiments can be set up with any number of treatments and individual or combined comet and micronucleus assays. You can create templates from past studies or experiments, so if you frequently use a particular study design, or want to perform a repeat of an experiment, you don’t have to re-enter any setup information, saving you time and preventing transcription errors. The system lists, organises, codes and decodes all your experimental items, making it easy to review group information, slides and even individual slide spots where multispot slides are used. The Cyto Study Manager can be used to manage batches of test items or control substances. Every chemical used in every study can be traced back to the specific batch used.

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Combination studies – multiple endpoints from a single experiment

If you are doing combination studies such as combined comet assay and micronucleus test, Cyto Study Manager will help coordinate your workflow while reducing study setup overhead. You only have to enter your treatment groups and sample information once, and can then assign two distinct assays to be conducted on the same hosts.

Review and approve your data

You can review, approve and archive your data all from within one screen.  Cyto Study Manager allows you to see all your experimental data, including images of scored comets and individual samples or slides which have been approved, edited or invalidated.  Result overviews allow the user to decide upon the quality of the data.  Users with the correct permissions can mark data as ‘approved’, ‘rejected’ or ‘archived’ and Cyto Study Manager allows users to apply electronic signatures to their decisions.

Generate reports

All your reports are generated from the within the system and can be automatically combined into the final study report. Reports can include sample coding/decoding information, results tables, historical data ranges, audit information and more. The report generator links to the R stats package for integrated statistical testing and graphing of data. 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. We can even tailor these reports to match your own corporate style.

Achieve regulatory compliance

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 Practise (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.

Cyto Study Manager includes a comprehensive and clear audit trail. All actions which are carried out within the Cyto Study Manager, such as designing a study layout or creating,editing and deleting data, are recorded within the audit trail. Every auditable event can be used to force a user into giving a reason for a change (e.g. when re-scoring a slide), or to force the user to re-input their passwords to confirm their identity.

Archiving and historical data

The system has been developed in accordance with the OECD series on principles of GLP and compliance monitoring number 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP. Archiving allows completed studies to be stored securely without the possibility of further changes or additions.

Should you need to review or report any archived study, users with the appropriate access rights can view and report upon archived studies. The ability to archive data, or search and view the archived files, can be assigned to as many users as your organisation requires.

Historical control data, along with all experiment data and information, is preserved within the Cyto Study Manager software and can be used routinely within your reports. Tightly regulated user-access ensures that only the appropriate people are able to view, edit or add to the historical data.

Reasons to buy

Remove experimental bias

During the scoring process, the system presents the scorer with a list of coded samples. They choose the sample they are going to score next and the scoring program is launched automatically. The scorer does not need to know any details about the sample they are scoring as all this information is handled invisibly by Cyto Study Manager.

Although the scorer is blind to sample information, Cyto Study Manager stores data against the appropriate sample automatically so study directors can review, approve and reject data in real time. The sample coding mechanism is completely customisable so codes can be generated to match with your current approach.

Faster study turnaround

Study templates allow you to copy previous study designs so you don’t need to worry about re-configuring, re-typing or re-entering setup information. Data collection is integrated with the system and as soon as data is collected, it can be reported. There are no transcription steps or file transfers. Reports are created automatically and can include data tables, graphs and statistics.

Increase traceability of data

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 Practise (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.

All actions which are carried out within Cyto Study Manager, such as creating,editing and deleting data, are recorded within an audit trail. Original data are never obscured; where a data change is made, the old and new values are visible along with any reasons given for the change.

Access anytime, anywhere

Because Cyto Study Manager is a private intranet-based web system, you and the other users can log in from anywhere with access to your company network… the lab, the office or even from home. Concurrent access log in allow multiple users to be logged in simultaneously – each can be working on the same or different investigations.

Expert support and software updates

When you purchase Cyto Study Manager, you will receive a comprehensive support package including software updates and unlimited support over phone, email and via screen sharing tools. We will install your system and provide training, report customisation and validation assistance to ensure that you get the best from Cyto Study Manager.

Regulatory compliance

You work to GLP, and so does Cyto Study Manager.

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 Practise (GLP) and the FDA 21 CFR part 11 rule on electronic signatures. Users with the appropriate permissions can apply electronic signatures to approve or reject experiment data.

Comprehensive auditing

Cyto Study Manager includes a comprehensive and clear audit trail. All actions which are carried out within the Cyto Study Manager, such as designing a study layout or creating, editing and deleting data, are recorded within the audit trail. Every auditable event can be used to force a user into giving a reason for a change (e.g. when re-scoring a slide), or to force the user to re-input their passwords to confirm their identity. Authorised users can use the audit viewer to review actions such as creations, modifications or deletions, and then generate reports.

Validation assistance

We are on hand to help with all your regulatory compliance documentation needs. For your assistance, we will provide all of our own project, testing and validation documentation along with IQ documents and training certificates.

Controlled user access

Within the Cyto Study Manager, every user can be assigned to a specific set of access rights and permissions. This means that actions such as viewing, editing and creating items within the Cyto Study Manager can be locked away from certain users. For example, you can:

  • allow study directors to see all information relating to a study, add annotations and electronic signatures as they wish
  • allow scorers to only see the coded sample information, leaving them ‘blind’ to the experimental setup
  • allow quality assurance staff to review studies without being able to edit, create or delete data.

GeneTox assays

Single or combination assays in vitro or in vivo

Cyto Study Manager lets you run comet assay, micronucleus and chromosome aberration assays, both in vitro and in vivo. Assays can be performed standalone or combined within the same experiment. Cyto Study Manager manages the entire slide preparation, coding and scoring process without the need for data transcription and translocation.

Final reports are generated in Microsoft Word format. Reports can include tables, graphs and statistics. Results and historical control data can also be exported to Excel for further analysis.

Comet assay

When performing the comet assay, the system presents the scorer with a list of coded slides. They choose the slide they are going to score next and Comet Assay IV is launched automatically. The scorer does not need to know any details about the experiment or the slides as all this information is handled invisibly by the Cyto Study Manager.

Data can also be imported from third-party data acquisition systems such as automatic slide scoring platforms.

Once the scoring is finished, the Data Viewer screen allows authorised users to access all the comet assay data from the investigation. Comet assay measurement parameters such as tail moment and tail intensity are displayed along with mean and median values. In addition, when used with Comet Assay IV, an image of each scored comet is captured and can be viewed within the system.

Micronucleus

Data from micronucleus investigations (both in vivo and in vitro) can be captured directly in Cyto Study Manager via an electronic tally counter, by data import from a flow cytometry system or by data import from an automatic slide scoring platform.

Data is captured in the system in real time, which is especially useful for laboratories using outworkers. No longer will you have to wait for data to be sent by the user; it is captured electronically in the system from the outworker’s location.

With the microscopy method, the scorer selects a slide (either coded or uncoded) from the list of available slides within the study. The scorer then uses an electronic tally counter to collect data directly into the Cyto Study Manager database. Once the scoring is finished, the Data Viewer screen allows the study director to access all data from the investigation.
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Chromosome aberrations

Using an electronic tally counter and a tablet PC next to the scorer’s microscope, the scorer uses a touchscreen interface to enter aberration information directly into the Cyto Study Manager system. For those using automatic slide scoring systems, data can be imported directly by uploading data files.

When performing the chromosome aberration assay, the system presents the scorer with a list of coded slides. They choose the slide they are going to score next and enter data using the tablet PC. The scorer does not need to know any details about the experiment or the slides as all this information is handled invisibly by the Cyto Study Manager.

Technical specification

Assay types

Comet assay and micronucleus assay, both in vitro and in vivo. Assays can be performed standalone or combined within the same experiment.

Comet assay data collection

Linked directly with Comet Assay IV or imported from third party systems using text file formats (e.g. csv, xml)

Micronucleus assay data collection

Can collect data via microscopy or flow cytometry. Electronic USB tally counters can be used for microscopy data capture. Data can be imported from third party systems (slide scoring platforms, flow cytometers) using text file formats (e.g. csv, xml) for either approach.

Reporting

Reports generated in Microsoft Word format. Reports can include any information included in the system and can be generated at any time. Reporting software interfaces to the R-Project stats package for inclusion of statistical tests.

Examples of reports include slide labels, experiment information, audit trail reports, final study reports, data tables, graphs and charts.

Data export

All comet and micronucleus scoring data can be exported to Excel. Text files used for data import are stored in the system and can be downloaded for use in third party programs.

Observations

Unlimited number of observation codes can be configured for slides, samples, hosts and flasks.

Study templates

Existing study and experiment designs can be saved as templates. Templates can also be designed from scratch. Use of templates speeds up creation of new studies.

User levels

User, Advanced User, Study Director, System Administrator, Auditor.

Historical controls

Historical controls database generated nightly. Past data can be imported into system and integrated with data present in Cyto Study Manager.

Archiving

Completed or abandoned studies can be archived and are no longer visible to users without the appropriate permissions. Archived studies remain in Cyto Study Manager database but are locked and no aspect of the study, or any part thereof, can be modified in any way.

User access rights

System Administrator can assign over 100 different rights/permissions for each user level.

Event settings

Every auditable event can be configured to require entry of a GLP reason or electronic signature.

Minimum specification

Web server: Windows Server 2008 or 2012. Database server: Oracle 11g or 12c database. Client PCs: Any Windows PC that can run a web browser.

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