Risk Based Monitoring & Technology Driven Solutions – Veranex Hosted Sponsor Visit at Bangalore, India Office

Veranex is pleased to have hosted a key meeting with a Generics & Biosimilars Sponsor at the Bangalore, India office on May 31^st, 2022.  This forum was key to showcase the innovation and implementation of our new-age technology and increase our market visibility.

The meeting, led by Soumitra Chowdhury (Executive VP, Data Management & Analytics) along with the Department Heads, focused on addressing salient industry challenges, including:

• Protocol Deviations Management System,
• Risk Based Monitoring Approach, and
• Data & technology driven solutions

KEY AREAS OF DISCUSSION

1. Protocol Deviation process, version control and audit trail within a Risk Based Management System
   • Multiple solutions were presented to track changes to this process and suggest mitigation steps.
2. Risk Based Monitoring Approach and Key Risk Indicators (KRIs) tracking solutions
   • Descriptive analysis (answers the question ‘What is going on?’) and
   • Predictive analysis approach where risk of the KRIs can be identified early using probabilistic and predictive modelling to different KRIs (answers the question ‘What is going to happen?’)
   • Prescriptive analysis or technology assisted data analytics and optimization to track the risk of the various KRIs and suggest mitigation steps (answers the question ‘What is the best course of action we can take?’)
3. Centralized risk reporting escalation and governance
   • A prototype to a new platform, was presented by our RBM team with a walk-through session. Advantages of this platform were highlighted:
   • Automated reports to help reduce time and effort — a cost-effective model for sponsors
     • Scheduling the monitoring visit based on risk category of the site
     • Early detection and reporting of risk to study team/CRA via manual or automated triggers fired when the predefined threshold is reached
     • CRA accountability for risk mitigation
     • Audit trail can be generated to track activities.