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news roundup
Pfizer has chosen inVentiv Health as one of its preferred providers for sourcing global clinical operations services.
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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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Study reveals that industry is shifting to adopt advanced electronic TMF applications.
Partnership aims to increase diversity at the clinical research investigator level.
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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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Oracle announced Pfizer has selected Oracle's Cloud Services for its entire clinical trial portfolio.
Read more about the exhibitors at DIA, and who announced what products and new deals.
Read up on people moves and business announcements for June.
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The State of Risk-based Monitoring (RBM)
On Demand
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Articles
Thoughtfully defining the objectives and the design, so that these elements remain unchanged throughout further development, increases the efficiency of the writing, and avoids inconsistencies in the final document.
CenterWatch survey finds the large number of disparate and incompatible solutions has left many sites feeling they are an afterthought in the design of eClinical technology functions and uses.
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Blog Posts
This framework shows how to design data collection criteria to identify enrollment bottlenecks during screening, and optimize enrollment performance.
Peter O'Donnell, our resident Brussels drug industry expert, explains the downstream drug development results from the UK's decision to leave the EU.
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Regulatory
In essence, the EMA says that the UK exit will not impact its work to protect human and animal health.
This article surveys several pressing regulatory topics around mHealth technologies, including good clinical practice (GCP), fitness of use, security/privacy, electronic records (and eSource data), researcher oversight, and inspection preparedness.
The three-part series outlines the implications and processes for ensuring compliance with ICH E6 (R2) changes that are scheduled to go into effect late 2016.
The EMA says that beginning November this year, organizations will need to make anonymized CSRs available within 60 days of an authorization decision.
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