Implementing a ‘press of a button’ score-based treatment path for site users

Cmed Data and Analytics team used innovation to customize technical solutions for a 300-patient study

 

Situation

A biopharmaceutical company had a Phase II study with 300 patients in 5 countries.

  • At a key point in the study each patient’s treatment path depended on a score calculated from data collected over the previous period.
  • The treatment path decision needed to be rapid, accurate and made in real-time.
  • To achieve maximum accuracy, the Sponsor did not want the calculation to be performed by the busy site staff.

Challenge

Cmed needed to:

  • Find a solution that would enforce a workflow to ensure the accuracy of the data used in the score calculation.
  • Provide a “press of a button” solution for users to make the correct treatment path decision.
  • Guarantee data traceability and integrity.

 

 

Solution

Cmed specializes in innovative technical solutions for our clients using encapsia, the game-changing EDC and analytics platform.

By the time of initial database Go Live, Cmed:

  • Implemented workflow controls to ensure and document entry and checking of the data required to calculate the relevant score.
  • Programmed and validated “buttons”: one to derive the score from individual data points comparing it to the baseline value, and a second one to determine the appropriate treatment path.
  • Provided users at site with automated messages to confirm successful completion of calculations and treatment path decisions.

Impact

Cmed provided:

  • A user-friendly solution which minimised the impact on busy site staff.
  • An accurate and validated method for score calculation supporting timely, consistent treatment path decisions which the sponsor knew would stand up to regulatory scrutiny.
Case Study Key Facts    
Size of study 30 sites, 300 patients
Type of study Phase II randomized study
Client type Mid-size pharmaceutical company
Client base UK team of US-based organization
Project timeline 2020
Other background Our client selected the Cmed Data and Analytics team for this project as other CROs were unable to handle this situation and they would have required a manual, site-based solution.

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