Life Sciences

Data Collection in Oracle Health Sciences Clinical One

Clinical One

Last week was clearly busy for Oracle. I attended three online events to learn more about Clinical One as the Data Collection capabilities were launched. 

Oracle revealed that Clinical One Data Collection will: 

  • Save time: Build a study in weeks instead of months; make midstudy changes in real time; deploy them in minutes without any cost 
  • Harmonize data: Eliminate inconsistent, incompatible, incomplete, missing, and duplicated data 
  • Streamline workflow: Put an end to numerous study builds, multiple validations, and complicated integration requirements 

I am starting to see how all of these benefits are real. The user interface is relatively intuitive, and there are short videos available, organized by role, to walk users through how to do specific tasks, such as Create a form and add validation rules and “Respond to a query.  

When building studies, it seems extremely simple to copy data entry forms from one study (or a library?) to another, including associated edit checks, if required. Validation is simplified as a record of the testing of edit checks is visible on-screen, and a Product Verification Pack (PVP) is issued with each quarterly release of Clinical One. This PVP contains a cumulative record of all functional requirements and includes test requirements, test cases, traceability matrix, etc. 

Oracle said that Investigator site users would only need to access three screens: 

  1. Dashboard 
  2. Subject / visit list 
  3. Data entry (within which users also respond to queries) 

This should mean that the users can become more familiar with the system, resulting in the more efficient management of data, queries, etc.  

There is one more online event this month: 

  • Clinical Leader Live Fireside Chat – June 30th @ 1:00 pm ET – register here 

In addition, to set the scene and start to get a feel for Clinical One, I recommend these two concise videosin which you see glimpses of the user interface: 

About the Author

Caroline Halsey has over 20 years’ experience in the clinical trials industry from various angles including consulting, data management, project and operational management. Recent responsibilities include oversight of the development of a bespoke medical coding system for a major pharma and working to develop InForm EDC study build services at Perficient, alongside responsibilities as Director within the Perficient Life Sciences Business Unit.

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