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news roundup
MedAvante released its Virgil Investigative Study Platform. This update streamlines navigation tools, improves the information display and makes the interface more user friendly.
This service provides biopharma companies with real-time temperature and location monitoring of investigational medicinal products from central distribution centers to clinical trial sites.
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Podcast: E-Signatures and Digital Workflows in Clinical Trials
In clinical trials, the use of eSignatures to improve document workflows such as protocols, informed consent, and investigator brochures, has increased. All documents that need signed approvals eSignatures can be implemented to streamline, improve and make the transferring of those documents more efficient. This podcast discusses areas in clinical trials where eSignatures and document workflow can be applied for upstream benefits.
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The National Board of Medical Examiners (NBME) has introduced the Certification of Excellence in Clinical Research (CECR). The goal of this initiative is to improve the quality of clinical research by testing the knowledge of clinical researchers.
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Click here  and press play in our video player to watch a short video about Covance's Xcellerate Insights collaborative workspace, making sharing and information access among project teams easier, more secure, and more efficient.
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What phase of clinical trials has the highest quality?
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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
Live Webinar: Tuesday, October 25 at 2:00 PM EST
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Vendor Overload? Integrating third party lab management to streamline clinical development
Live Webinar: Thursday, October 27 at 11:00 EDT
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Articles
Dr. Catherine Bonuccelli, Vice President and Therapeutic Area Head of Respiratory at GSK, discusses the Salford Lung Study, its patient-centric design, and how it is different from the traditional randomized clinical trial.
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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.
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Experts may evaluate similar adverse events differently. In this article, the authors compared the assessments of 50 ADRs made by four experts from a clinical research organization and clinical trial investigators, analyzing the reasons for different evaluations. |
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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What's Your Drug Regulatory Knowledge?
Medical Device pros...how well do you know regulatory for drug development?
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Blog Posts
The recent approval of the National Institute of Health's (NIH) policy, Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research, will require researchers to change current practices that technology can support.
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Regulatory Changes in India and What It Means for Clinical Research in the Country
Live Webinar: Wednesday, October 19 at 11:00am EDT
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Pharma sponsors and CROs must incorporate translation management during the planning phase of a global clinical trial launch.
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Simplifying the complexities of global rare disease drug development
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Mobile Health
Results indicate that pharma and biotech are expected to increasingly use digital health tools over the next five years.
ERT surveys patients on how they prefer to interact with eCOA when completing those assessments during clinical trials.
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This peer-reviewed article discusses pressing regulatory topics that clinical trial researchers need to consider when using mHealth technologies, including good clinical practice (GCP), fitness of use, security/privacy, electronic records (and eSource data), researcher oversight, and inspection preparedness.
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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
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