Electronic Data Capture

Collecting information on paper forms to re-enter it later into a computer system is a double-entry process that adds the risk of transcription errors and takes extra time. Entering data directly into a database via electronic case report forms eliminates the paper step.

Switching to electronic data capture (EDC) becomes an even more compelling choice for pharmaceutical manufacturers and CROs who face an increase in data volume, rising costs, and new drug innovations that target smaller segments of the population. Companies must cut their development overhead. Switching from paper-based to electronic data capture can lead to cost savings, higher quality data, and a higher degree of security.

Entrypoint i4 and EDC

Entrypoint is a proven electronic data capture system used by leading CROs and pharmaceuticals. The software has been validated according to FDA guidelines.

  • All data resides in a centralized database.
  • Data can be accessed remotely via Internet browsers.
  • Entrypoint i4 runs on Windows, Mac or UNIX operating systems, on computer desktops or handheld devices.
  • Entrypoint application development is local, but the application is directly connected to the database; finished applications can be uploaded to the Entrypoint server directly from the Application Studio.
  • Operators can enter data via Internet browsers or the Desktop Workstation.

Electronic Signatures

Electronic signatures can be set up easily in Entrypoint i4 using access level and EntrypointScript. Many of our customers have used this approach in order to conform to FDA regulations or ensure data entry accountability. Since every data entry action is recorded in the Event Log, Entrypoint i4 maintains a comprehensive history of what users are responsible for what data.

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