news roundup
Oncology-focused biotech chooses Medidata Rave for Phase I and II trials for blood cancer and solid tumors.
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NORD's Rare Diseases and Orphan Products Breakthrough Summit is the most meaningful multi-stakeholder event – historically featuring over 20 speakers from the FDA, participation from over 80 patient organizations and the Pharma/Biotech industry's foremost experts in orphan product innovation, investment and commercialization.
The 2016 Summit is your opportunity to address the progress and innovations in rare disease diagnosis, treatment, engagement and access of orphan products.
 Learn more
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INC selected 40 high-performing clinical research sites to participate in the initial launch of its Vaccine Catalyst Site network, which was formed to respond to the rapid growth and strong pipeline of vaccine studies.
Bioclinica has acquired Compass Research, a Fla.-based clinical research site network with access to patients with neurodegenerative disorders and other diseases found in older populations.
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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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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
Modeling and simulation, also known as biosimulation or model-informed drug discovery and development, can deliver significant business, scientific and clinical value to firms that fully utilize it as an integral part of their drug development strategy.
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Transforming Patient Recruitment through Patient and Site Engagement
Live Webinar: Tuesday, August 23, 2016 at 11 am – 12 noon EDT
 Register now
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In this large trial, a "hub and spoke" regional coordinating center model was developed in an effort to better oversee the conduct of the trial at widely dispersed clinical sites. Regional coordinator and physician positions led each region and bore responsibility for training, protocol adherence, and quality.
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Blog Posts
HTA bodies are increasingly present in discussions of marketing authorizations at the European Medicines Agency and elsewhere.
Why educating the public about clinical trials as an alternative care option is the industry's next great challenge.
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Regulatory
The EMA has proposed changes to current guidance on first-in-human clinical trials. Interested parties have until September 30, 2016 to respond.
Wingspan Technology announces the release of Wingspan eREG to its Life Sciences Solution and manages documents included in regulatory submissions and related documents.
European consumer group sees faster approval pathways by the EMA as "sidestepping the standard benefit-risk assessment for licensing a medicine," and wants to see tight limits imposed on the exercise.
This article surveys several 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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