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news roundup
Comprehend recently released a survey of over 100 Clinical Operations leaders providing consensus on their goals, challenges and best practices for CRO Oversight.
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Many clinical trials rely on clinician-administered assessments. MedAvante's research has shown that electronic clinician outcome assessments (eCOA) administered with the Virgil platform demonstrate substantially reduced error rates compared to paper-based assessments.  Click here to learn how using eCOA can standardize assessments and reduce error, thereby strengthening signal detection.
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The EMA has released an update on its plans to revise the existing guideline on first-in-human clinical trials. The revised guideline is open for public consultation until February 28th, 2017.
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 Click here and press play in our video player to watch a short video about Covance's Xcellerate Monitoring solution, to help you prioritize patient safety and data quality, support protocol compliance, and optimize resource utilization.
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Clinerion's new PRS Patient Finder tool is used with its Patient Recruitment System to address personalized, precision and/or orphan treatment access and options.
The American Heart Association's Precision Medicine Platform will include a vast array of curated rich datasets related to cardiovascular disease, that are centrally stored, easily searched and accessible, and managed on the Amazone Web Services cloud.
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The Next Wave of Centralized Monitoring
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Vendor Overload? Integrating third party lab management to streamline clinical development
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Articles
The challenge, some say, is to keep the biosimilar clinical trial small to avoid unnecessary costs and delays, yet have it large enough to produce useful and interpretable data.
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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.  Learn more |
Tom Krohn, former Director of Clinical Open Innovation at Eli Lilly, and current Chief Development Officer at Antidote, discusses the company's approach to patient trial matching.
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Pediatric Oncology Trials: Changes on the Horizon
Live Webinar: Tuesday, December 13 at 2:00 pm EST
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Blog Posts
One of the major areas where the aerospace field is creating a blueprint that can be replicated, is its approach to operations. Lean operating is in the aerospace sector's DNA.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST
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As the EMA claims, the information is comprehensive. On the two medicines included so far–Kyprolis and Zurampic–there are a quarter of a million pages of information for over 100 clinical reports.
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RBM
Trial sponsors and CROs can expect plenty of tough questions to be posed about whether their current technology platform can really support the next iteration of RBM.
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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
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CluePoints will work with the Metrics Champion Consortium to help drive collaboration in the development of a standardized framework for centralized monitoring.
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Simplifying the complexities of global rare disease drug development
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Learn more about CBI's RBM Europe conference to be held in Barcelona, March 15 and 16, 2017.
In this 5th Edition of Applied Clinical Trials' on RBM, the focus is on quality risk assessment, management and planning.
Risk-based centralized monitoring offers innovative solution in tracking and controlling sites performance almost real time basis which is otherwise intricate with only traditional on-site monitoring approach.
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