Home / Insights / Optimizing Clinical Monitoring Practices Risk Based Monitoring

insights-espresso-icon whitepaper

Optimizing Clinical Monitoring Practices Risk Based Monitoring

Espresso-live Speakers
by Ashwini Tripathi , Senior Research Analyst
17 June 2014

Traditionally, the sponsors believe that regulatory agencies expect frequent onsite monitoring visits assuming the fact that 100% Source Data Verification (SDV) is required for all trials irrespective of study design or complexity. Even with intense monitoring, neither the integrity of data nor investigators performance has improved. A large amount of capital is spent in clinical research which usually takes eight to ten years to arrive to a result. Clinical monitoring accounts for about 35-40% of clinical development project cost. It is one of the largest drivers of cost in a clinical trial and plays a critical role in ensuring the conduct and fortune of a clinical trial to bring the investigational drug to market. But over the time Sponsors and CROs have built a paradigm for the necessity for intense monitoring by performing 100% source data verification (SDV) to assure the integrity of the study processes and data. The evolving clinical trial industry is looking forward to streamline the processes of clinical monitoring to improve patient safety and data integrity.

SHARE
Linkedin Twitter Facebook
Leave a comment

Please enter a valid name

Post your comment

Please select captcha

Instagram

Get more stories like this

Subscirbe for more news,updates and insights from Beroe

Get Ahead with AI-Enabled Market Insights Schedule a Demo Now

Schedule a Demo Now