ACT

Sep. 27/2016

news roundup

ICON Completes Acquisition of
Clinical RM

ICON's acquisition of Clinical Research Management, Inc. (ClinicalRM), a provider of full service and functional research solutions to U.S. government agencies, extends its presence for government-sponsored research.


Validic Releases Digital Health Survey Results

Validic's 2016 Global Pharma and Biotech Survey on Digital Health indicates that pharma and biotech are expected to increasingly use digital health tools over the next five years.


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Click here to watch a short video about Covance's Xcellerate Forecasting & Site Selection tool, which helps forecast study timelines and supports selection of optimal investigator sites.


Polaris Pharma Selects Medidata Payments

Oncology-drug focused Polaris Pharma has selected Medidata Payments to streamline its clinical trial site reimbursement process.


Latest Business and People News

Updated people moves and business recognition for September.


Is a Clinical Trial a Product or a Service?

In our latest poll, 54% of you said a clinical trial was a service, while 20% of you said it was neither. What is a clinical trial?


In this edition

ICON Completes Acquisition of Clinical RM
UCLA Studies Participant Payment
Can Emerging Markets Advance mHealth?
Don't Miss RBM 2016—Risk-Based Management and Monitoring Event
Regulatory—Calvo Elected to Second EMA Term

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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 Register now


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Events

Risk-Based Trial Management and Monitoring
Partnerships in Clinical Trials
NORD 2016 Rare Diseases & Orphan Products Breakthrough Summit
Search more events

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Simplifying the complexities of global rare disease drug development
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Articles

Can Emerging Markets Advance mHealth?

Digital platforms have the potential to facilitate clinical trials in underserved populations where lack of infrastructure has made traditional research models unfeasible.


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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.learn More


Data Decision Debate: to Share or Not to Share

We conducted an investigation specifically to identify and describe the basic requirements for technology solutions, as well as the factors considered by successful lean outsourcers in selecting and implementing the right solutions for their companies.


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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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Blog Posts

Data Extrapolation to Support Pediatric Labeling

A series of Congressional and FDA rulings led industry to conclude, incorrectly, that efficacy trials in pediatric patients were required in order to incorporate a claim for pediatric use into product labeling.


UCLA Studies Participant Payment

UCLA knew that its trials were being affected by payment issues, but wanted to examine whether or not the mechanism for patient reimbursement impacted patient retention.

Regulatory

Calvo Elected to Second EMA Term

The Healthcare Professionals' Working Party (HCPWP) of the European Medicines Agency (EMA) has re-elected Dr. Gonzalo Calvo as its co-chair.


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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
On-Demand
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Regulatory Professionals Spend More Time on Strategy

The Regulatory Affairs Professionals Society (RAPS) released its biennial survey, the 2016 Scope of Practice & Compensation Report for the Regulatory Profession, featuring results from 3,358 regulatory professionals in 56 countries.



EMA's Future Location In Doubt After Brexit Vote

According to an EMA statement issued in early July in response to the “Brexit” vote, "The implications for the seat and operations of EMA depend on the future relationship between the U.K. and the EU."


CFDA Updates Processes

Nearly one year has passed since the CFDA was pushed to accelerate its activities to promulgate new or updated regulations and guidelines. This article examines the progress on reforms to date.


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Lisa Henderson
Editor in Chief
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Mike Tessalone
Publisher
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