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home > white papers > The Role of the CRO in Effective Risk-Based Monitoring - Medpace |
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WHITE PAPERS |
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Medpace
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The Role of the CRO in Effective Risk-Based Monitoring
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The clinical trial industry is evolving. In an effort to improve
participant safety and data integrity, regulators are encouraging trial
sponsors to transition from a focused on-site monitoring approach they
have traditionally employed toward a risk-based approach that utilizes a
combination of centralized and on-site monitoring techniques to ensure
patient safety and data quality. The Risk-Based Monitoring (RBM)
paradigm has many potential advantages over established monitoring
practices including enhanced patient safety and data integrity, more
efficient and effective protocol design, reduced costs, and the ability
to strategically adjust oversight in keeping with changes in risk level.
Realizing the potential of RBM requires early planning,
analytical expertise, sophisticated tools and process adaptability. Deep
cross-functional expertise early in the trial process enhances the
ability to assess overall risk, define critical data and processes,
develop an integrated plan for addressing risk, and execute a monitoring
plan that meets the trial’s unique requirements.
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News and Press Releases |
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EVERSANA’s Data & Analytics Platform ACTICS by EVERSANA Named a 2022 Artificial Intelligence Award Winner
CHICAGO – March 22, 2022 – EVERSANA™, the pioneer of next-generation
commercial services to the global life sciences industry, today
announced its technology-enabled platform ACTICS by EVERSANA™ has been
named a 2022 Artificial Intelligence (AI) Award winner.
More info >> |
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White Papers |
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Contemporary Issues in Comparator Trial Supply
Clinigen CTS
As trial design and execution becomes ever-more complex, initiatives to
adapt, increase efficiency and control costs without compromising
quality become paramount. Here, Clinigen CTS covers the broad issues and
summarises the responses our industry is making in this increasingly
demanding landscape.
More info >> |
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