logicStudy

logicStudy represents a clinical data management system to collect, review, monitor and analyze data for clinical trials. Low cost – high efficiency! logicStudy provides you with necessary features leaving out a great number of unnecessary and confusing modules not needed in many applications.

logicStudy supports the entire process from study design over EDC and monitoring to data analysis.

logicStudy ensures that data are correctly filled in, reviewed, monitored and documented according to the following steps.




Features

  • Simple software architecture structures allow for easy use and make sure that study can be designed and performed fast and on low budget.
  • logicStudy supports multi-site clinical trials.

Study Design

  • Study design and configuration is done by logic DATA GmbH as a service that relieves the sponsor of unnecessary tasks.
  • Study design is done by experts.
  • This strategy results in speed and quality.

Roles

User access is controlled by predefined roles and permissions for:

  • Sponsor and team,
  • investigator and team,
  • monitor and team,
  • administrator and team.

Electronic Data Capture (EDC)

Simple overview and navigation allows for easy intuitively use by investigator.

  • Controls and operating components use the English language.
  • Patients or subjects are treated anonymously.
  • Data entry is dynamically validated by format and range.
  • Alerts prompt corrective action or reasons for override.
  • Data are reviewed and will be checked during the monitoring process.

Monitoring

Monitoring interacts smoothly with the EDC process.

  • Monitoring is done on bases of the statements.
  • Each entry has to be checked by monitor prior to finalization.
  • Altered entries demand once more approval by monitor.

Confirmation

After monitoring all finalized documents (first of all: visits) will be reviewed, printed on paper and signed by the investigator.

  • This avoids unnecessary risks and expenses.
  • No security measures according to 21 CFR 11 will be needed.

Web Based Hosting

  • No installations and configurations are on site.
  • Data are stored in a central database accessible any time, any place.
  • Data are always consistent, available, secured and backed up.

Data Export & Analysis

  • Simple export functionality is available.
  • All documents can be exported in the pdf format.
  • Data for analysis can be selected and filtered for exports as CSV or MS Excel files.
  • Prepared MS Excel templates are made available for data analysis.

Security Measures

Login

  • Login only for authorized persons,
  • login with username / password,
  • limited attempts of login.

EDC

  • Information that is wrong or no longer needed is flagged or marked internally but not deleted.
  • Full audit trail is available.

Data transmission

  • Htps secure data transmission,
  • data encryption and security certificate.

Hosting

  • Fire wall,
  • antivirus system,
  • raid server,
  • on demand: certified hosting according to ISO 2701.

Support

  • Training on site,
  • email support,
  • telephone support 8/5.