In this ISSUE

Rare Diseases: Meeting the Unique Challenges of Orphan Drug Development

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

Real-World Evidence Studies

Trial Management

Single IRB Review for All Multicenter Clinical Trials

Since the emergence of the independent IRB sector, sponsors have found that regulatory and ethical review by a single IRB yields important benefits with respect to efficiency, high quality, and consistency in human research protections.
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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

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.

Calendar

/ Rare Diseases & Orphan Products Breakthrough Summit 10/16-10/17 /

/ Speed to IND for Biologics 10/19-10/20 /

/ Interactive Response Technologies in Clinical Trials 2017 10/26-10/27 /

/ Data Privacy Summit for Life Sciences 10/30-10/31 /

Global Trials

Clinical Trials in Kazakhstan: Open For Business

This brief overview of Kazakhstan presented by Vlad Bogin will help you get acquainted with this emerging clinical trial location.
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Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT

Medical Devices

Big Changes for EU Medical and In Vitro Diagnostic Device Regulations

The EU is launching a major transition within their legislation for medical and in vitro diagnostic devices. This transition is important and should include assessing the financial viability of the pipeline, expanding data collection, and locking in soon-to-be-scarce notified body resources.
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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand

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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.

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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

Regulatory Authorities, FDA

FDA Seeks More Informative Clinical Research

There is a critical need to rethink standards of evidence and of the reliability of information used to make regulatory decisions. According to the FDA, this involves placing greater reliance on data from sources outside traditional clinical studies and because of these new tools for collecting the data, the FDA needs to adapt as well.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
On Demand

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Regulatory Authorities, EMA

EMA Rings Alarm Bells Loudly on Brexit Move

The EMA isn’t mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. It has been stated that “the future of public health in Europe is at stake” and this decision will make or break it.
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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand

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