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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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PCI Announces Expansion of its Industry-Leading Cold Chain Infrastructure with Dedicated Minus 40 degrees C Facility
Philadelphia, USA – August 29, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, Clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce the completion of a purpose built -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.
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White Papers |
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Pharmaceuticals and Healthcare Products
Turkish Cargo
Pharmaceuticals are requiring safe and reliable transportation for being highly temperature sensitive products. Thosepharmaceuticals are; diagnostics, vaccines drugs, sera, plasma, protein clinical trials, biotechnological material, pills and all kind of medicines. Turkish Cargo transports all kind of pharmaceuticals, and has been carrying out its operations of transporting and storing drugs and temperature-sensitive medical supplies successfully and with the experience of 80 years; since 1936.
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Industry Events |
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Pharma and Device Packaging and Labelling West Coast 2018
27-28 November 2018, Burlingame, CA
The second edition of the Pharma and Device Packaging and
Labeling West Coast was a thought-provoking two days of engaging presentations,
discussion and networking.
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