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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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Novo Nordisk Pharmatech A/S signs distribution agreement with DKSH for twelve countries in Asia Pacific
Novo Nordisk Pharmatech A/S and DKSH, have partnered to provide
high-quality cGMP quaternary ammonium compounds in twelve countries
across Asia Pacific
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White Papers |
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Time lapse photography to demonstrate the potential antimicrobial abilities of Dycem contamination control flooring
Dycem
A defined volume of bioluminescent reporter bacteria was deposited onto 20 mm x 20 mm coupons of Dycem flooring, vinyl tile and ITW Alma tacky mat. Through monitoring of bacterial bioluminescence, metabolic inhibition was observed on all three surfaces however the effect occurred more rapidly on Dycem flooring than on vinyl or ITW Alma. Recovery counts after three hours of exposure to the floor surfaces showed between a 65% and 100% decrease in the number of viable organisms recovered from Dycem flooring compared to controls. On vinyl and ITW Alma flooring, there were slight increases in the number of viable survivors recovered compared to controls. Dycem flooring inhibited the metabolic activity and reduced the number of viable survivors recovered of Salmonella enterica Serovar Typhimurium DT104 pGLITE. It remains unclear as to whether this effect is attributable to the impregnated biocide or rapid drying of the inoculum on this surface.
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Industry Events |
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ASGCT 22nd Annual Meeting
29 April - 2 May 2019, Washington Hilton, Washington, D.C
The 2019 ASGCT Annual Meeting is expected to be the largest in Society
history, eclipsing the mark set by the 2018 meeting just last year. Join more
than 3,500 researchers, clinicians, advocates, and industry leaders in
discovering the latest science and technology surrounding gene and cell
therapy.
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