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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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Northway Biotechpharma and Hansa Biopharma initiate a new Contract Development and Manufacturing project in immunological diseases
Vilnius, Lithuania, and Lund, Sweden - December 20th, 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced a new service agreement to develop the next generation of IgG cleaving enzymes.
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White Papers |
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Running Smarter Trials With Data-Driven Monitoring
PAREXEL
Clinical monitoring remains one of the most important and most costly activities in the clinical research paradigm. Monitoring provides the operational transparency required by investigators, sponsors, and regulators to make informed decisions about site performance, patient safety, and overall study progress. Yet unlike many clinical trial activities, which have been steadily transformed by technology, the monitoring function itself has changed little.
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Industry Events |
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INTERPHEX 2020
28-30 April 2020, Javits Center NYC
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