Clinical Trials Software - configurable for any trial
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About the Astracore Clinical Trials System

Flexibility

Our clinical trials management system is suitable for virtually any controlled clinical trial, including randomized trials, with a choice of randomization algorithms. Clinical trial software is easily configured for paper CRF (Clinical Report Form) and provides eCRFs (electronic CRF). The software can be configured to capture data in a vast number of forms and techniques, with specific rules as defined by you, to build in integrity and quality checking.

The system can be used for direct Electronic Data Capture (EDC), i.e. eCRF, or to print paper CRFs which could consequently be entered into the system.

CRFs

CRFs can be defined with virtually any formats of variables and predefined values including:

  • dropdown, radio button, multiselect, dates, integers, string, decimals etc
  • dynamic dependent variables (skip logic)
  • calculations on a variable
  • conditional forms which triggered by defined conditions
  • range checks
  • regular expression test
  • conditional logic to apply during data entry

You can also attach images, audio, video, documents (say consent forms) etc., limited only by the amount of storage available.

Double Data Entry

The system is Double Data Entry enabled and has detailed exception reporting. This includes and option to lock records once they have been matched, to prevent any further changes.

Access Control and Audit

Access is controlled via multi-level security profiles and contains full audit trails of changes.

Trial randomization can be automated with predefined algorithms and where required, the data entry interface can be in languages other than English.

Invoice Module

Optional invoicing and billing module to invoice for services from a price book. Interfacing to external accounting systems for debtor and GL data can be provided, or tracked in the Astracore Accounting System.

Analysis and Reporting

Analysis and reporting of data is comprehensively available with charts, dashboards, filters, reports and listings, to name a few. Most are able to be created, maintained and executed by users however if something very complex is required, Astracore can provide customised views and reports. All reports, filter and list results can be printed, saved and/or downloaded for further analysis.

More details are available in the Astracore Biobanking System White Paper, available above.

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Important Notices:
version: 1.0.188