news roundup
The combined companies of H20 Clinical and Pharma Start will provide full-service CRO services in biostatistics, data management, clinical operations and medical writing, as well as other ancillary services.
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Unlock the full potential of RBM using this new framework which integrates EDC with advanced RBM tools and goes beyond identifying risk to enable immediate action!
Listen to this podcast to learn how
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The Regulatory Affairs Professionals Society's biennial survey finds those professionals spending more time on strategic activities.
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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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Updated for August, who has new positions and which companies are receiving accolades.
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Drive better outcomes with improved trial design Live Webcast: Tuesday, September 27 at 11:00 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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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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Articles
Despite new and evolving outsourcing models that sponsor companies have implemented—from transactional to functional service provider and integrated alliances—drug development operating performance has not improved.
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In late July, the EMA published a concept paper on "changes intended to support best practices," on progressing from the conduct of non-clinical studies to clinical trials for investigational drugs in humans. The agency is seeking comments before the end of September.
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Blog Posts
The European Union is offering $350 million in grants for developing personalized medicine next year—but with "open science" strings attached.
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Transforming Patient Recruitment through Patient and Site Engagement Live Webinar: Tuesday, August 23, 2016 at 11 am – 12 noon EDT
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Risk–Based Monitoring
This article examines how technology solutions can provide significant benefits to implementing RBM and remote trial management.
Keith Howells, Senior Vice President, Development for OmniComm Systems describes the drivers to write support for RBM into its EDC system four years ago.
With recent changes in industry execution and increasing experiences with using RBM, many colleagues need information on how to write an RBM plan.
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