Features and Highlights

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Time advantage: Reports in half the time (instead of 30 days, less than 15 days)

  • Pre-fabricated, professionally designed layout (can also be adapted to individual requirements).
  • Pre-fabricated standard tables with automatic row and column labeling (using the meta data of the study).
  • A fully automatic table of contents, figures, and tables with automatic numbering, renumbering and updating - reduces many steps in Word to one single mouse click.
  • Faster import of completely formatted tables with results (text, ASCII) and figures (automatic layout or format specified by the user); automatically complete tables positioned on a page - time consuming editing is no longer necessary.
  • Stereotype standard texts ('boilerplates') are integrated as well as special templates (summaries in dynamic form, flowcharts, etc.).
  • Intelligent program: automatic formatting, indentation, page layout, tables in dynamic form.

GCP standard: Reports are validated and conform to GCP guidelines

  • Automatic, validated direct import of external figures and tables with results (text, ASCII).
  • Audit paper trail for the configuration of every study.
  • The program is SOP and users' directions for the form and content of the complete report.

Ensuring a high standard of quality

  • The user adopts the structuring and organization as developed by specialists based on 30 years of experience with study reports.
  • Templates are based on modern Biometry ICH guidelines E3, E6, and E9 (e.g. effect size measures and confidence intervals, concomitant factors of the study).
  • Option with the program: completely designed chapter templates with user directions including a description of procedures and help with the interpretation. Key areas are: disposition of patient, baseline comparability, efficacy (descriptive and interferential statistics), evaluation of laboratory data. Tutorials with datasets for practice and certification are included. Certification is within the framework of the certification series "Master of Clinical Studies".

Everything can be configured (customizing)

  • The developer can implement standards relating to the customer (logo, layout, new functions, etc.)
  • The ICH-Study-Report Manager can implement a global standard for all possible employees and branches of a particular firm.

User friendly - Reliable results conforming to ICH guidelines

  • Users do not require specialized skills or knowledge. The program is based on Microsoft Word.
  • Even complicated table formats can be easily developed using the offered templates and layout-automatic.
  • Users require very little knowledge of the ICH guidelines. They are able to obtain the essential specialized knowledge quickly and easily by means of the certificate series "Master of Clinical Studies", offered with the program.