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