ACT

June 28/2016

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news roundup

Brexit Result Creates Uncertainty for EMA and Drug Developers

Britain's unprecedented vote to leave the EU will have major ramifications for biopharma, including in areas such as drug regulation and R&D.

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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


CenterWatch Joins WIRB-Copernicus Group

IRB-Copernicus Group has acquired clinical trials information provider CenterWatch, and added its founder and owner, Ken Getz, to WCG's board of directors.


BBK, Apptomics Partner on Health Monitoring Solutions

BBK Worldwide has struck a deal with Apptomics to develop a new suite of mobile applications for patients, caregivers, physicians and payers.


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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


DIA: Latest Product Announcements

Read more about product releases at DIA, as well as exhibitor profiles, speakers, blogs and podcasts with DIA presenters.

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In this edition

DIA: Latest Product Announcements
Brexit Creates Uncertainty for EMA and Drug Developers
CenterWatch Joins WIRB-Copernicus Group
RBM—Quality Remote Monitoring: The Tools of the Game

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The State of Risk-based Monitoring (RBM)
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Articles

Future Directions of Cancer Immunotherapy in Clinical Trials

Trial design innovation in immuno-oncology will continue to be molecularly driven, focusing on understanding the genomic aberrations of patients—with collaboration and big data playing prominent roles.

EMA's New Tool: PRIME

A look at the EMA's recently launched PRIority MEdicines (PRIME) drug approval scheme, which hopes to build upon existing regulations in Europe to support product development in cases of unmet medical need.


Blog Posts

Q&A: Research Data Promise vs. Reality

Ken Getz of the Tufts Center for the Study of Drug Development discusses how better integration of health data and technology will be critical to future gains for clinical research.

Are You Prepared to Replace the Thorough QT Study?

Planning ahead can save time and money later, thanks to recent regulatory changes in cardiac safety guidance.

Events

Pharmacovigilance Final Rule Summit on IND Safety Reporting
Risk-Based Trial Management and Monitoring
Search more events

RBM

Quality Remote Monitoring: The Tools of the Game

Outlining those technology solutions best poised to raise the data and process quality of risk-based monitoring and remote trial management.

Four Tips on Writing an RBM Plan

Highlighting the key steps in developing a risk-management process to create an RBM plan—ideally during the study design phase.

Preparing for the ICH E6(R2) Addendum: Part 3

In the final entry in a three-part series on ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year, the value of embracing a centralized, technology-driven approach to RBM is explored.



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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com

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Mike Tessalone
Publisher
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