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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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POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS
A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6
Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers |
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SuperCapSyringe®
Weibel CDS AG
Safer, easier and faster drug delivery – Weibel CDS AG, Switzerland develops and produces innovative, user friendly, application oriented injections systems and devices. The SuperCapSyringe® product family upgrades your vial practically to a prefilled syringe. Based on a modular design, the syringe is fully adaptable to your application needs. It is supplied in different sizes and, as a novelty, with staked needles including a passive safety device.
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Industry Events |
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14th Annual Biomarkers & Immuno-Oncology World Congress
11-13 June 2018, Westin Boston Waterfront, Boston, Massachusetts
The Biomarkers and Immuno-Oncology World
Congress brings together a unique and international mix of large and
medium pharmaceutical, biotech and diagnostics companies, leading universities
and clinical research institutions, government and national labs, CROs,
emerging companies and tool providers—making the Congress a perfect
meeting-place to share experience, foster collaborations across industry and
academia, and evaluate emerging technologies.
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