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OCTOBER 3/2017


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news roundup

Survey Addresses Sharing Clinical Trial Results with Patients

TrialScope announced findings from its sponsor survey on clinical trial results sharing practices at CBI's conference this past week. The survey focused on obtaining feedback from sponsors about their current approach to trial results summaries.


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Rare disease trials differ from those in most other therapeutic areas because the indications are more complex and involve smaller patient populations. In a series of white papers, PRA experts discuss the barriers drug developers face when positioning a new trial in the rare disease space and how to minimize these while engaging with the right patients.
Learn more


Ergomed Acquires for Orphan Drug Expertise

Ergomed plans to acquire PSR Group BV, a specialist orphan drug CRO, established in 1998 and based in the Netherlands.


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Tomorrow's Clinical Trial, Powered by Modern EDC
See how to cut study build time in half, eliminate migrations, and remove the need for source data verification (SDV).
See a preview and watch the full webinar here.


EFPIA Report Highlights EMA Relocation Risks

A new 25-page report commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the serious risks posed to public health by the relocation of the European Medicines Agency (EMA).


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Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT
Register now


PSI CRO Chooses goBalto

PSI CRO has chosen goBalto's suite of study start-up applications for all their studies on a worldwide basis.

In this edition

Consider Kazakhstan for Clinical Trials
EFPIA Report Highlights EMA Relocation Risks
FDA Seeks More Informative Clinical Research
New Rules for European Investigational Medicines

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Improve clinical trials today!
Join industry leaders from pharma, biotech, CROs, health care organizations and advocacy groups to advance patient and physician participation in clinical trials. At the Bridging Clinical Research & Clinical Health Care Collaborative, we will discuss how we can bridge people and processes, regulatory and technology. Become a sponsor!
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Events

Speed to IND for Biologics
Risk-Based Trial Management and Monitoring
IRT 2017
Search Upcoming Events

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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
Click here to watch all 10 short videos


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Articles

MCC Examines Aligning Data Entry and Site Payments

The Metrics Champion Consortium (MCC) recently issued two reports based on industry surveys of data entry timeliness by sites and on site payments. The reports indicate that, in general, organizations do not have an effective way of tracking and managing the timeliness of data entry or the timeliness of site payments.


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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
Live Webinar: Wednesday, October 25 at 11:00am EDT
Register now


Consider Kazakhstan for Clinical Trials

This article explores this Eurasian Economic Union country's healthcare system, regulatory process, and infrastructure for potential viability in conducting trials.


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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
On Demand
Learn more

Blog Posts

FDA Seeks More Informative Clinical Research

Former FDA commissioner Robert Califf noted at a recent conference that the traditional system for evidence generation has become "bloated and burdened" and is "not generating the evidence that is needed."


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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand
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New Rules for European Investigational Medicines

A new regulation setting out GMP for investigational medicinal products will enter into force on October 9, but national authorities in the EU member states will have until April 2018 to modify their national legislation accordingly.


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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand
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Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com