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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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Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations
Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
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White Papers |
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Advantages of Quantitative NMR for the Determination of Relative Response Factors
Novatia, LLC
Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.
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Industry Events |
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World Vaccine Congress Europe
28-31 October 2019, Barcelona, Spain
The 20th annual World Vaccine Congress Europe is taking place 28-31 Oct in Barcelona.
It’s the biggest and most established European vaccine event with over 250 speakers,
700+ senior vaccine attendees, hundreds of networking hours.
It cover key topics across the complete vaccine value chain bringing together:
• Government
• big pharma
• big biotech
• SME Biotech
• academia
and the wider service provider community and their partners to discuss scientific,
clinical and strategic advances and opportunities.
The event has already confirmed over 200 speakers from Human Vaccine Project, OECD,
CEPI, European Commission, FDA, WHO, OECD, NIH, GSK and many more…
There is a Super Early Bird offer available – Find Out More
www.terrapinn.com/WVCEU/EBR
More info >> |
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