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news roundup
Based on the recent death in a Phase I trial in France, the EMA is seeking to revise guidance to improve risk-based strategies.
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 Click here to watch a short video about Covance's Xcellerate Informatics platform, an innovative 4-module solution to optimize the planning and execution of clinical trials.
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Medidata and Memorial Sloan Kettering Cancer Center will pilot a study in a treatment for multiple myeloma using wearable sensors and mobile technology to evaluate patient quality of life during treatment.
A survey conducted by Worldwide Clinical Trials shows sponsors are increasingly outsourcing to CROs, which demonstrates the role CROs are playing in modern drug development.
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Unlock the full potential of RBM using this new framework which integrates EDC with advanced RBM tools and goes beyond identifying risk to enable immediate action!
 Listen to this podcast to learn how
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Find out who has a new position, which companies received awards and recognition in the updated business and people news section.
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Articles
In this case study, Chiltern describes its internally developed training program for medical device studies using eLearning modules to train its CRAs.
OmniComm's Keith Howells speaks to ACT about whether electronic data capture (EDC) can be considered innovative in today's pharma.
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Transforming Patient Recruitment through Patient and Site Engagement
Live Webinar: Tuesday, August 23, 2016 at 11 am – 12 noon EDT
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Blog Posts
An FDA Advisory Committee heard discussion on allowing Continuous Glucose Monitoring (CGM) devices to be used for non-adjunctive endpoint measurement, replacing the traditional finger-prick to measure HbA1c or glucose levels in a patient's blood.
At a recent event, industry experts shared their knowledge on running high quality, small budget clinical trials covering clinical operations to clinical data management and biostatistics.
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Risk-Based Monitoring
The E6 (R2) addendum to Good Clinical Practices has the potential to change the way clinical monitoring and trial management are conducted by requiring adoption of centralized, quality risk management (QRM) throughout the trial lifecycle.
This article discusses technology solutions that can provide significant benefits to implementing RBM and remote trial management.
This article offers general tips but it is important to emphasize that RBM plans vary from one study to another.
The current eSource transformation is fraught with challenges that must be overcome, including regulatory compliance, cooperation, and acceptance by the patients and clinical research sites.
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