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"Ganstat" software package

  Optional services

"Ganstat" is a web based software package for collecting on line CRF data (mostly for medical research). The software is multi-user and simultaneous enabling data entree by many medical centers/personal in real-time.

  • e-CRF form design using:
    • Your forms in HTML format.
    • Conversion of your electronic forms to HTML.
    • Conversion of your paper forms to HTML.
    • Designed from your protocol or other specifications to HTML.

  • Server selection:
    • HTTP server:
      • Ganstat secured server.(Maybe hosted according to clients request).
      • HTML pages in private directory with or without password protection.
      • Secure SSL server (https).

  • Workflow process:
    • Access level control defines database viewing rights (each doctor can only see his patients, Medical center manager can see only his center data, study monitor can view all data).

  • Data monitoring and validation:
    • On-line checks: Missing data, range checks, cross-item consistency, etc.
    • Real-time graphic meters show % of data entered.
    • Back-end data validation: Programmed cross-form checks, cross-patient, cross-visits, etc.

  • Query resolution:
    • Queries appear on patient chart at real-time to be viewed by all authorized personal. Queries cc. to sponsor.
    • On-line query database.

  • Data Verification:
    • Verification is done by the CRA who checks the data and electronically locks the page. A visual monitoring symbol is presented in the main CRF table showing the verification status..

  • Database export:
    • Frequency of database exports as desired by client (Daily, weekly, monthly, final only etc.)
    • Format of export database: According to client needs.

  • Statistical Analysis:
    • Receiving the data from the database is fast and reliable enabling immediate processing in any statistical software.
    • In "Gan Statistics" we transfer the data to "stata" software.
    • We provide intermediate statistical analysis and final full reports according to the clients needs.

"Ganstat" main features
  • Web-based data capture system using standard browser.
  • No software, hardware, or plug-ins needed.
  • Real-time access to all clinical trial data.
  • Intuitive friendly web-forms (e-CRF) with:
    • Radio-button choices.
    • Drop-down selections.
    • Context sensitive menus open in real-time according to selection.
    • Unlimited text boxes for comments.

  • Data entry validation checks performed in real-time.
  • Security:
    • Centralized database on servers according to client desire.
    • SSL security servers and protocol.
    • Encryption of data on servers.
    • Password control (with levels of authority).
    • Access rights controlled and configurable at any time.

  • Full back-end clinical data management and programmed data validation checks.
  • Full automatic Audit Trail tracking.
  • Simple on-line query system, all queries recorded in database.

  Method of work

  Preliminary understanding - our first step is to meet the client, understand his needs (the study objectives, protocol, CRF, scope of the study, time frame, budget etc.).

Preparing an offer - We prepare a detailed offer for the study and agree with the client that it covers all issues which are important to him.
  Pre Study preparations - We support the client with defining the study objectives, Review the Protocol and CRF to assure they are written in the most suitable and effective way.

e-CRF tailoring - We prepare a special e-CRF which will provide the most efficient and cost-effective solution to the clients needs.

Data Collection - the data is collected by e-CRF (or manually- by paper CRF) and we manage and monitor the data collection through out the study.

Statistical Analysis - is done only after the data in verified as valid and final. We use the "Stata" statistical software.

Final report - We prepare a full and detailed final statistical report with all the relevant data, charts etc.
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