Program Features and Highlights (Selection)

Data Entry in accordance with GCP and FDA 21 CFR part 11

As fast as lightning - Preparation of the entry structure with plausibility boundaries and format definition.

Comprehensive idv SOPs for encoding characteristics and preparing structures in accordance with GCP. 

Secure data entry with plausibility testing: The possibility of saving queries and/or commentaries with every entry.  26 different Missing Value Codes.

Built-in Double-Entry Features: Automatic comparison of the  first and second entry, protocol output, option for direct correction

Study management

Audit protocol in accordance with GCP and FDA 21 CFR Part 11: Different audit levels: Audit-Paper-Trail for data entry and data changes with time stamp, authentication, etc.

Query Management: Automatic query management. Convenient preparation of query printouts for submission to the clinical investigator.

Automatic table generation for the clinical study report

Important database operations by pressing a button: Routine operations such as Last-Observation-Carried-Forward option and data transformations such as the introduction of changes from baseline - just press the right button!

Special tables based on medical reference values.

Tables conforming to ICH E3 guidelines (almost immediately)

Table headers with an Audit Trail conforming to FDA 21 CFR Part 11l: Sponsor, Study, Work file, Output name, Date, Time, Page-ID, Program, Version number.

Summary statistics for the tables: classic and robust standard ensembles as well as free selection.

Special tables required by the guidelines (e.g. Shift-Tables with appropriate statistics by pressing a button).