news roundup
Cinven's acquisition of Bioclinica is expected to bolster growth and raise the company's international profile. Bioclinica President and CEO John Hubbard, PhD will continue in his role, as well as the executive officers who will remain in their current positions reporting to Hubbard.
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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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Boehringer Ingelheim and the Duke Clinical Research Institute will expand their Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry. The expansion of this registry is designed to uncover insights into the rare disease.
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Drive better outcomes with improved trial design
Live Webcast: Tuesday, December 6 at 11:00 EDT
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The Study Pal app looks to provide protocol overview, device/drug and procedure training material and study communications to its users.
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New challenges in pharmacovigilance — preparing for ICH E2B (R3) and IDMP implementation
Live Webinar: Wednesday September 21 at 11:00 AM EDT
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Simplifying the complexities of global rare disease drug development
Live Webinar: Thursday, September 15 at 11:00 EDT
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Articles
TransCelerate's mutual recognition program for EDC system training creates a framework that can enhance and simplify site training, and give sponsors confidence in the process.
Using core labs expert physicians as independent reviewers as a risk management strategy. |
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Blog Posts
Over the past two decades, Eosinophilic Esophagitis (EoE) has transformed from a case-reportable disease to the second most common cause of esophagitis and the most common cause of food impaction. New therapies are required to address this rare disease. |
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Regulatory
The ICH business plan anticipates finalizing ICH guideline for Good Clinical Practice (E6) in November 2016 and regulatory implementation in mid-2017.
The EMA has published a final report about its pilot project on adaptive pathways, which it describes as a product development concept for medicines that address patients’ unmet medical needs.
According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. |
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