Monitoring Assessment

Imagine an inspection is announced at your site and the Sponsor asks nervously if your CRA has been assessed this year on their monitoring quality.

This costly process is often forgotten or performed late.

Here we come in! We have created a comprehensive, realistic, and on-demand training solution for Clinical Research Organizations!

How it works

The Monitoring Assessment is fully virtual, simulating a real site with:

•   Source Documents
•   Case Report Forms (CRFs)
•   Study Protocol and Supporting Documents

Our documents are designed to ensure CRAs can quickly grasp the study’s details and expectations. During the assessment, CRAs will:

•   Perform Source Data Review (SDR) and Source Data Verification (SDV)
•   Check the Investigator Site File
•   Conduct Investigational Product (IP) Accountability
•   Participate in an interview to assess their social skills

At the end, you’ll receive a comprehensive Monitoring Assessment Report. This report will cover overall CRA performance, understanding of SDR/SDV, and include findings and suggestions for improvement.

You will also obtain a dated certificate that will demonstrate the timing of the CRA quality assessment performed.

Why it is worth it for CROs:

  1. Train CRAs to meet high standards in protocol, data quality, and compliance, all in a realistic setting.
  2. Our virtual training eliminates travel expenses and lets you train multiple CRAs efficiently.
  3. Assess CRA decision-making and site relationships through data-driven, life-like simulations.
  4. CRAs can train anytime, anywhere, removing time zone and travel barriers.
  5. Prepare CRAs to detect risks early, protecting patient safety and trial integrity.
  6. Show sponsors your commitment to quality with our advanced CRA training.

Contact me

×