The iStudyReporter Bioanalytics Solution

iStudyReporter Bioanalytics replaces the complex conventional process creating bioanalytical reports with an automated solution. While querying current data in Thermo Scientific™ Watson LIMS™; iStudyReporter Bioanalytics provides a simple and fast way of generating regulatory bioanalytical documents such as validation and analytical reports, completely eliminating the need for manual steps, table formatting and complex checks to ensure data validity.

iStudyReporter Bioanalytics also comes with a fully featured template management system for creating and coordinating a variety of sponsor-defined templates according to the requirements of a CRO or contract research organisation. The wide-ranging set of predefined standard tables and graphics simplifies the process of creating and adapting new custom templates. The broad range of document management functions make document creation simple and reliable, while ensuring transparency. Intuitive user interfaces keep the training effort for users and admins extremely light.

FDA published a new guidance on the standardization of validation studies in Mai 2018 also addressing the submission format. iStudyReporter Bioanalytics is already covering this guideline and will lift your lab to the next level of automation. It is the industry standard for the automated creation of submission documents from Watson LIMS.

Benefits of iStudyReporter Bioanalytics:

For decision makers

  • High efficiency: Fully automated generation of complex reports and approval documents including graphics and statistical analyses within minutes at the click of a mouse.
  • Simplification and standardisation of reporting processes while increasing data security and reducing error rates.
  • Substantial time and cost savings with efficient report creation, elimination of QC checks and maximisation of the number of reports generated.
  • Validated data transfer from the LIMS into reports.
  • Protected reports with version management without the need for double-checking.
  • Structure according to current official requirements
  • Fast implementation and seamless integration into existing IT environments.
  • Low licensing costs with concurrent users.

For report writers

  • Enormous relief: Fully automated generation of complex reports and approval documents including graphics and statistical analyses within minutes at the click of a mouse.
  • Simplification and standardisation of reporting processes while increasing data security.
  • Increase in performance, focus on core activities.
  • Protected reports with version management without the need for double-checking.
  • Structure oriented towards real-life application with an intuitive user interface.

Do you have any questions about iStudyReporter?

Need more information, or would you like to arrange a meeting with us?

We would be pleased to help you out, and would welcome the opportunity to talk to you.