CluePoints Relies on CTG to Integrate Regulatory Compliance Into Its Scrum Development Process

Our Client 

CluePoints is a software and service provider of intelligent statistical risk-based monitoring solutions used in clinical trials by biopharmaceutical and clinical research organizations to ensure the quality and integrity of data, enhance patient safety, and reduce regulatory submission risk. CluePoints was launched in response to industry guidance from the Food and Drug Administration (FDA) and a reflection paper from the European Medicines Agency (EMA) encouraging sponsors to embrace an alternative to traditional on-site monitoring techniques and to explore reduced SDV using a risk-based approach to monitoring.

Challenges and Objectives

In developing software solutions that applied statistical methods to other functionalities, CluePoints needed to incorporate regulatory compliance into its Scrum software development methodology. Its primary business objectives were to: 

  • Produce a quality software product ensuring clinical trial data of the highest quality; and  
  • Confirm that its Scrum development process would successfully meet compliance and validation requirements and pass regulatory agency inspections. 

CTG’s Solution: 

CTG provided a solution to enhance CluePoints’ understanding of pharmaceutical regulatory compliance and guide them in integrating compliance into its Scrum development process. This was accomplished through a workshop with major CluePoints stakeholders that: 

  • Assessed CluePoints’ requirements and needs related to the Scrum development process and regulatory compliance; 
  • Shared knowledge on the key facets of Scrum development in a regulated environment; and  
  • Defined a strategy for a Scrum development lifecycle that incorporated compliance and validation. 

Additional consulting services were then provided as follow-up support and feedback during the Scrum development and regulatory compliance integration process. 

Results  

The primary project business objectives were accomplished, resulting in multiple benefits to the client, including: 

  • Enhanced ability to respond to customer input and rapid changes in the market while controlling regulatory and patient safety risks; 
  • Higher-quality product with fewer defects, increased productivity, and better change management controls; 
  • Documented evidence confirming that the software product does exactly what it is designed to do in a consistent, replicable manner; and  
  • Higher customer satisfaction and trust.
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