Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 3

A more effective approach is to establish a centralized monitoring system with flexible, robust
monitoring plans to address priorities, risks and thresholds, and ensure a focus on the critical data
and other aspects of the trial. The system should provide near real-time data tracking, automated
risk-based key indicators reporting with workflows and alerts to enable proactive decision making.
Pharmaceutical, biopharmaceutical and medical device companies alike have an increased
need for process and system optimization, risk mitigation, compliance assurance, and greater
efficiency. However, results of a survey of trial managers suggest that they may be suboptimally
using clinical trial data management systems, thereby missing an opportunity for significant
increases in efficiency in terms of time, costs, use of resources and quality of the data.3
This whitepaper explains how increased use of a technology-amplified, real-time, risk-based approach
to monitoring not only helps ensure the integrity of data and patient safety, but can also optimize
trial efficiency and quality. The paper also describes how digital monitoring can dramatically change
sponsor, CRO, and trial site team interaction; how companies can maximize the benefits of the latest
trial management technology; and how to choose and effectively work with a digital CRO.

Wanted by Regulatory Agencies: A Risk-Based Approach to Monitoring »

FDA Guidance:
I
 ncrease trial monitoring
efficiency by utilizing a
real time EDC system to
assess site risk factors.

The U.S. Food and Drug Administration (FDA),4 European Medicines Agency (EMEA),5 and other
regulatory agencies, such as MHRA,6 are placing greater responsibility on sponsors to take a more
proactive approach to clinical development to ensure compliance and mitigate risks. To that end,
draft guidance from the FDA, published on August 24, 2011, and EMEA guidance promote a more
systematic, risk-based approach to monitoring clinical investigations, combining centralized and
on-site monitoring.
The FDA guidance says advances in technology should allow sponsors to handle much of trial
monitoring electronically instead of physically sending monitors to each investigative site every four
to eight weeks, a current common practice. The guidance encourages use of EDC systems capable
of assessing quality metrics in real time to help monitors identify high-risk trial sites that need
closer attention to keep quality high. Sites with higher risk merit more visits, and those with less
risk or poor enrollment should be monitored from a distance and visited less frequently.

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