Entrypoint Clinical Trial Features
While many clinical trials software packages consist of one fixed system for all trials, all environments, and all types of data, Entrypoint is highly flexible. Case report form templates for a typical clinical trials application—with fields for demographics, medical history, examination data, adverse reactions, and lab information—are available on request (view demo). You can use these templates out of the box, customize them—or you can develop an application from scratch.
Entrypoint includes other features critical for clinical trials:
- Powerful security options: the tools to allow or prevent access to different parts of the system for different users.
- Full audit trail: Entrypoint auditing conforms to current guidelines published by the US Food and Drug Administration Title 21, Part 11.
- Comprehensive field checking: An extensive suite of field and form validation checks.
- Multiple users can use a batch simultaneously: Monitoring staff can review data already entered in the system while your data entry team is entering new records in the batch.
- Create paper studies or eCRF forms: Use the applications you create in Entrypoint for electronic data entry or print paper forms and scan the completed forms for key-from-image entry.
- Remote data entry: Entrypoint i4 consists of a WebClient application (accessed through a web browser) and desktop applications—the Application Studio development tool and the local Workstation, which provides additional advanced data entry features.
- ePRO patient diaries: Patients can be granted limited access to Entrypoint to enter information into a diary online or via a handheld device.
- Data export: Entrypoint provides a variety of exporting options to make your data quickly available for statistical analysis. Formats include comma-separated variables (CSV), XML, PDF and SAS-readable files that can be imported into the SAS ETL exporter, and then exported to multiple formats.
- Batch revision: If you have to update an application because of protocol changes during an ongoing study, Entrypoint i4 indicates when the new version of the application is deployed so that you can revise all associated batches.
- Software validation: Entrypoint follows procedures that conform to the current guidelines in Title 21, Part 11.