Clinical Trials Monthly Case Study Analysis

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question this month it’s a look at SAFETY and ADVERSE EVENTS and the value of an electronic, real-time reporting system.

The Scenario: Criterium conducted a multi-center study across continents that required time-sensitive safety review but posed the challenge of a 7-hour time difference.

We asked ourselves:
What If: We could program our in-house EDC to provide real-time data in order to review safety information on an ongoing basis and make important study decisions; the absence of which would significantly impact safety and the overall project goals.

Criterium Patient Profile Reporting: The PatientProFileTM

  • In 2006, Criterium developed the PatientProFileTM reporting system to provide real-time information to our New York data center from our South African clinical operations office where enrollment was ongoing.
  • By integrating required safety data into a PatientProFileTM reporting system, we allowed for important medical safety review without having to take the significant 7-hour time difference into account and improved the Data Management process.
  • The PatientProFileTM reporting system connected two continents participating in a single clinical trial. As of 2013, the PatientProFileTM reporting system is used in all our clinical trials, USA-based and Global.

Patient Safety and Reporting

The PatientProFileTM reporting system produces individual reports for clinical trials, integrating data such as Demographic, Laboratory Results, Adverse and Serious Adverse Events into simple, real-time reports that can be reviewed as data is entered on an ongoing basis from any web-based computer.

The benefits of the PatientProFileTM reporting system are many and include, but are not limited to:
– Provision of data to Data Safety Monitoring Board(s)
– Review of data for interim analysis
– Provision of adverse event trending information
– Abstract/manuscript preparation
– Go/N-Go decisions

Our Result: The PatientProFileTM reporting system allowed the sponsor to make important safety decisions and necessary changes to the study design that provided scientifically valid data and protected the safety of all trial participants.

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