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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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Innovative Micro-Infusion Pump for Gerresheimer Subsidiary Sensile Medical Developed and Successfully Launched for EVER Pharma
Düsseldorf/Olten, July 03, 2019 – Developed specially by Sensile Medical
for EVER Pharma under the brand name D-mine®, this wearable
microinfusion pump recently received European CE certification and has
already been launched in several European countries. The compact,
patient-friendly infusion pump is used for the continuous subcutaneous
administration of drugs to treat Parkinson’s disease. The first micro
pump from Gerresheimer subsidiary Sensile Medical to be available on the
market, it gives Parkinson’s patients greater independence in their
day-today lives.
More info >> |
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White Papers |
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Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments
World Courier
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
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Industry Events |
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2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
2020, in Amsterdam, The Netherlands.
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