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Study Management

We have been working with the genetic toxicology experts across the globe to create and develop computerised systems to improve the data handling and study management of your GeneTox Assays.

Currently, we have systems developed specifically for the Ames test, the Comet assay and the Micronucleus test.

How do study management systems work?

Our systems have a number of features which allow you to create and store your GeneTox experimental information and study data. You can design studies, then acquire and report data for that study from within one GLP-compliant, regulatory approved, software system.

  • Study design – You can create study and experiment design “templates” which can be used as the basis for future experiments.  Ultimately, using templates speeds up study design and increases your team’s productivity.
  • Data acquisition – Study management systems integrate with data capture programmes such as Sorcerer Colony Counter and Comet Assay IV.  Data is automatically transferred to the study management system and saved securely. Samples can be coded so that human bias is eliminated.
  • Report generation – Generating final and interim reports can be done at the push of a button. Reports are produced in a protected Microsoft Word format. These reports can be customised and tailored to the requirements of your company, and can include statistics, graphs and information such as historical control data.

Benefits

  • Remove bias – automatically generate coded samples so your scorer or lab analyst has no knowledge about which sample he or she is working with.
  • Reduce paperwork – our secure, electronic systems can help you reduce the amount of paper records you need to keep.
  • Minimise human error – with integrated data acquisition and reporting,  there is no need to copy and paste or re-type data from one system to another.
  • Increase productivity – organisations can save a substantial amount of time and money by switching from a paper-based system to one of our study management solutions.
  • GLP and regulatory compliance – all our systems are designed to work within a GLP compliant environment and are comprehensively tested and validated in accordance with our ISO9001:2008 certified Quality Management System.
  • Comprehensive auditing and user control – all our systems include comprehensive audit trails and work to the requirements of 21 CFR part 11 rule on Electronic Records and Electronic Signatures.

Cyto Study Manager

Cyto Study Manager has been designed to integrate all your comet and micronucleus data management processes into one simple, easy-to-use system that can be accessed securely from the laboratory and the office via your organisation’s own internal network.  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.

Ames Study Manager

Ames Study Manager is an integrated suite of software for conducting the Bacterial Reverse Mutation Test according to regulatory guidelines e.g. OECD 471, ICH S2RI etc.  It has been designed to fulfil the requirements of safety assessment laboratories in pharmaceutical, medical device and chemical companies as well as contract research organisations. Ames Study Manager is found in laboratories across the globe and has an excellent reputation for increasing productivity whilst maintaining compliance to GLP regulations and requirements.

Free trial

Contact us now for a free trial or demonstration of our study management systems.

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