ACT

August 23/2016

news roundup

Two US-based CROs Merge

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


Regulatory Professionals Spend More Time On Strategy

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


Latest People Moves

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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Events

Risk-Based Trial Management and Monitoring
NORD 2016 Rare Diseases & Orphan Products Breakthrough Summit
Search more events
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In this edition

Latest People Moves
Sponsors Missed Opportunities with CROs
EU Grant Will Require Open Access to Data
RBM—Quality Remote Monitoring: The Tools of the Game

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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

Sponsors Missed Opportunities with CROs

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.


Phase I Death in France Leads to EMA Rule Changes

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.


Blog Posts

EU Grant Will Require Open Access to Data

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
Register now


Risk–Based Monitoring

Quality Remote Monitoring: The Tools of the Game

This article examines how technology solutions can provide significant benefits to implementing RBM and remote trial management.


OmniComm Tech Chief Discusses EDC-RBM Connnection

Keith Howells, Senior Vice President, Development for OmniComm Systems describes the drivers to write support for RBM into its EDC system four years ago.


Four Tips for Writing an RBM Plan

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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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com

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Mike Tessalone
Publisher
mtessalone@advanstar.com