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OCT. 11/2016

news roundup

MedAvante Updates eSource Platform

MedAvante released its Virgil Investigative Study Platform. This update streamlines navigation tools, improves the information display and makes the interface more user friendly.


Parexel Launches Active Tracking Services

This service provides biopharma companies with real-time temperature and location monitoring of investigational medicinal products from central distribution centers to clinical trial sites.


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Podcast: E-Signatures and Digital Workflows in Clinical Trials
In clinical trials, the use of eSignatures to improve document workflows such as protocols, informed consent, and investigator brochures, has increased. All documents that need signed approvals eSignatures can be implemented to streamline, improve and make the transferring of those documents more efficient. This podcast discusses areas in clinical trials where eSignatures and document workflow can be applied for upstream benefits.
Click here to listen


NBME Offers Certification in Clinical Research

The National Board of Medical Examiners (NBME) has introduced the Certification of Excellence in Clinical Research (CECR). The goal of this initiative is to improve the quality of clinical research by testing the knowledge of clinical researchers.


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Click here and press play in our video player to watch a short video about Covance's Xcellerate Insights collaborative workspace, making sharing and information access among project teams easier, more secure, and more efficient.


Polling Open Now

What phase of clinical trials has the highest quality?


In this edition

Parexel Launches Active Tracking Services
GSK Addresses Clinical Outcomes Through Patient-Centric Studies
Using Technology to Support NIH Policy
mHealth—Validic Releases Digital Health Survey Results

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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
Live Webinar: Tuesday, October 25 at 2:00 PM EST
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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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Vendor Overload? Integrating third party lab management to streamline clinical development Live Webinar: Thursday, October 27 at 11:00 EDT
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Articles

GSK Addresses Clinical Outcomes Through Patient-Centric Studies

Dr. Catherine Bonuccelli, Vice President and Therapeutic Area Head of Respiratory at GSK, discusses the Salford Lung Study, its patient-centric design, and how it is different from the traditional randomized clinical trial.


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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.
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Interexpert Agreement for Adverse Events Evaluation

Experts may evaluate similar adverse events differently. In this article, the authors compared the assessments of 50 ADRs made by four experts from a clinical research organization and clinical trial investigators, analyzing the reasons for different evaluations.


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Drive better outcomes with improved trial design Live Webinar: Tuesday, December 6 at 11am EST
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Test Your Knowledge

What's Your Drug Regulatory Knowledge?
Medical Device pros...how well do you know regulatory for drug development?
Learn more

Blog Posts

Using Technology to Support NIH Policy

The recent approval of the National Institute of Health's (NIH) policy, Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research, will require researchers to change current practices that technology can support.


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Regulatory Changes in India and What It Means for Clinical Research in the Country
Live Webinar: Wednesday, October 19 at 11:00am EDT
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Top 3 Translation Strategies for Global Trials

Pharma sponsors and CROs must incorporate translation management during the planning phase of a global clinical trial launch.


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Simplifying the complexities of global rare disease drug development
On-Demand
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Mobile Health

Validic Releases Digital Health Survey Results

Results indicate that pharma and biotech are expected to increasingly use digital health tools over the next five years.


What Do Patients Want in an eDiary?

ERT surveys patients on how they prefer to interact with eCOA when completing those assessments during clinical trials.




Regulatory Topics Surrounding mHealth in Clinical Trials

This peer-reviewed article discusses pressing regulatory topics that clinical trial researchers need to consider when using mHealth technologies, including good clinical practice (GCP), fitness of use, security/privacy, electronic records (and eSource data), researcher oversight, and inspection preparedness.


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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
On-Demand
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Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com