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news roundup
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a survey to better understand how it can support its customers in the run up to the country's exit from European Union.
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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
 Click here to watch all 10 short videos |
Catalent Pharma Solutions is investing $5.5 million at its 200,000+ square foot Philadelphia, PA site to provide additional clinical packaging and storage capacity. The 22,000-square foot expansion will see a 40% increase in pallet space for both refrigerated and ambient storage, the addition of multiple cold chain packaging areas, and a new clinical label control area. All work is scheduled to be completed and validated by November 2017.
A recent public opinion survey commissioned by Research!America, found the percentage of respondents citing 'lack of trust' as a reason declined by as much as 15% among minority groups and the population overall.
According to the Tufts—Veeva 2017 eClinical Landscape Study report, it takes companies an average of 68 days to design and release a clinical study database. Delays in releasing the study database lead to increased time for other data management processes, such as patient data entry and time to lock the database at the end of the study.
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Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT
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Articles
The new regulations replace earlier EU directives and add stringent new requirements for CE Marking of new and existing devices. On May 26, 2020, any new medical device certified in the EU must comply with the new requirements of the Medical Device Regulation (MDR). On the same date in 2022, any new in vitro diagnostic device must be certified under the new In Vitro Diagnostic Device Regulation (IVDR).
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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
Live Webinar: Wednesday, October 25 at 11:00am EDT
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This peer-reviewed article explores how sites tackle enrollment rescue situations, and provides some best practice considerations for how both sponsors and sites can make the most of these circumstances.
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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Live Webcast: Tuesday, September 26, 2017 at 1:00pm EDT
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Blog Posts
As sponsors jumped at the chance to implement new site-facing technologies and processes, they ended up creating a fragmented ecosystem of different software, hardware, vendors, and processes—one or more for each “silo” that exists within the sponsor/CRO world.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
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Experts make the case for single IRB review for all multicenter trials and encourages sponsors and CROs to limit the choices for review and set the stage for the benefits.
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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand
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Risk-Based Monitoring
This peer-reviewed article reviews the PUEKS project, which has devoted two years to the evaluation and optimization of RBM.
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This article provides the lessons learned as the biopharmaceutical industry explores Risk-Based Monitoring (RBM) as a part of Risk-Based Quality Management (RBQM).
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