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Industry Overview:

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. Regulations and corporate standard operating procedures (SOPs) are constantly evolving, making traditional approaches to training difficult and cost prohibitive to deliver.

Challenge:

Bringing new drugs to market can take a decade or more and cost billions of dollars. Timely completion of clinical studies is critical yet 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 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.

Solution:

A challenge-based microlearning platform, Qstream uses scenario- based questions to improve critical thinking skills, skill proficiency, and on-the-job behaviors.

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

Results:

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.

Using Qstream, the clinical training team now has real-time data about each site monitors competencies.

“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

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