Customer Story: Global Biopharmaceutical Leader Reduces Clinical Trial Risks by Improving Site Monitor Proficiency for RBM

Challenge-based Learning Scenarios Enabled Clinical Operations Team to Integrate Critical Thinking Skills and Improve RBM Practices

Site monitors are critical to the success of clinical research and trials, especially to support RBM process improvements. They play a key role in reducing risk and ensuring patient safety. It’s a highly regulated job function performed by trained professionals at clinical trial monitoring sites around the world.

Regulations and corporate standard operating procedures (SOPs) are constantly evolving, making traditional approaches to training, such as classroom or in-person workshops, difficult and cost prohibitive to deliver.

The Challenge

Bringing new drugs to market can take a decade or more and cost billions of dollars. Timely completion of clinical studies is critical, as every delay translates into lost sales. But research reveals almost 80% of all clinical studies are not completed on time, and 20% of those are delayed six months or longer¹.

The clinical trial program process is also complex and the risks are both significant and consequential. Clinical trial monitors are responsible for reporting accurate data back to the trial sponsor while closely following the International Conference on Harmonization (ICH), Good Clinical Practice(GCP), and SOPs.

 

“We needed to figure out where to start. What our site monitors know and what they don’t know, so we could focus our efforts. Qstream’s unique approach trims the fat so we can target individual competencies more effectively.”  

— Clinical training manager

 

The Solution

Global biopharmaceutical leaders choose Qstream for clinical research education because it delivers:

  • Real-time proficiency data for each monitor
  • Gap assessments in knowledge and compliance with regulations and SOPs
  • Continuous assessment and reinforcement of desired behaviors
  • Targeted opportunities for precision coaching and remediation

 

“You either know what is happening in the dataset or you do not. The consequences of not knowing can be tens of thousands of dollars and patients experiencing adverse events, or even dying.” 

— Clinical training manager

 

A challenge-based microlearning platform, Qstream uses scenario-based questions to improve critical thinking skills, skill proficiency, and on-the-job behaviors. The strategic combination of Qstream’s instructional design methodology and client services ensures desired outcomes are achieved.

Using Qstream, the clinical training team now has real-time data about each site monitor’s competencies, enabling them to:

  • Continually adapt re-training or future programs to address the biggest gaps
  • Support managers or team leaders to deliver personalized coaching
  • Launch new Qstream challenges on topics where monitors need the most improvement

 

The Result

“Qstream is a common sense approach to a common problem that trainers and managers face everyday.” 

— Clinical training manager

 

  • Diagnostics identified gaps correlated to performance for precision coaching opportunities
  • Challenge based learning developed critical thinking and led to behavior change
  • Continuous assessment increased site monitor compliance with regulations and SOPs
  • ROI from initial pilot achieved within the first year

 

Download a printable version of this customer story here.

 

If you are responsible for clinical research operations or site monitor enablement and training, get in touch for an introduction.

 

1 http://www.appliedclinicaltrialsonline.com/sponsor-investigator-relationships-crisis-trust-life-sciences