Pharmaceutical companies currently face the challenge of making the approvals process more efficient, speeding up official approvals for pharmaceuticals, and bolstering market position and competitiveness.

iStudyReporter from the up to data software house is a unique custom solution aimed at extremely efficient approval document creation for pharmaceutical companies while significantly reducing errors, streamlining approval procedures and cutting the time required.

The iStudyReporter solution

iStudyReporter is an innovative standardised product family that automatically generates complex study reports and approval documents from a whole variety of data sources within a matter of minutes. These documents are compliant with all of the international regulatory and statutory requirements including all of the necessary graphics and statistical analyses.

up to data developed the iStudyReporter product family together with leading international pharmaceutical companies. These solutions are compatible for integration into existing IT environments with almost real-time data transfer from all of the major LIMS, ELN, CDS, ERP (SAP), MES and similar software solutions. Tables, graphics, statistical diagrams, trend reports, QC charts, and similar are all customisable to corporate guidelines using iStudyReporter, completely eliminating the need for time-consuming processes such as intermediate manual steps and QC checks.


product family benefits

  • Automates lab procedures from creating approval documents to submission
  • Eliminates the need for manual steps and time-consuming intermediate procedures in creating approval documents
  • Reduces reviews to content, eliminating the need for data verification
  • Simplifies and streamlines the entire approvals process
  • Increases data security and traceability
  • Integrates seamlessly into existing IT and application environments
  • Generates more approval reports in a given time window


product family features

  • Remote Collector queries all of the data sources available for relevant information while maintaining complete transparency and validity.
  • iStudyReporter uses the data collected and automatically generates complex documents within minutes at the click of a mouse.
  • The documents are based on a variety of MS Word templates according to purpose and recipient, and include additional text blocks and information such as study data and titles.
  • iStudyReporter also provides predefined configurable tables and graphics for generation in a template.
  • The tables generated are transferred into a template.
  • Template management simplifies the process of handling different templates from study sponsors.
  • Continuous versioning management in iStudyReporter eliminates the need for additional checks and reviews.
  • An audit trail ensures consistent change tracking in approval reports.