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.
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.
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.