In this ISSUE

Clinical Trial Quality and Compliance Update

What's Behind the Clinical Innovation Gap?

Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management
Thursday, June 28, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST

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Clinical Research Associates

CRA Skills Lacking in Critical Areas

A global CRO's data gathered using an objective monitoring simulation administered by CRA Assessments, LLC reveals that CRAs are consistently underperforming regardless of the level of experience or training.
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FILLING THE GAPS IN SITE SELECTION
What You Don't Know Can Help You
Thursday, June 21, 2018 at 11:30am EDT
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EU Regulation

EMA's Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for Sponsors

From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.
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Driving Product Development and Finding the Fast Track in Early-Phase Oncology Programs
Tuesday, June 19, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST

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Calendar

/ 7th Annual Publication and Clinical Trial Transparency 6/20-6/21 /

American Pharma Outsourcing Summit 10/2-10/3 /

/ Crossroads: An Artia Solutions Conference 11/7-11/9 /

Design of Early Phase Clinical Trials: How to Increase Efficiency and Probability of Success?
On Demand

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Ask the editor

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

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Todd Baker
Group Publisher
todd.baker@ubm.com

Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC-MS: Latest Trends and Recommendations
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mHealth

Clinical Trial mHealth Update: an EU Perspective

The biopharmaceutical industry continues to explore how mHealth can change clinical trials, as the discussion continued at Hanson Wade's mHealth for Clinical Trials EU Summit in London.
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Is RBM living up to the hype? The state of RBM in clinical development
Wednesday, June 13, 2018 at 11am EDT

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Research and Development

Gottlieb Seeks More Efficient Clinical Research Strategies to Lower Drug Costs

Jill Wechsler interviews FDA Commissioner Scott Gottlieb about his push for more efficient R&D to help lower drug prices.
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The Future of ECOA
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Rare Diseases

Gene Therapy in Rare Diseases: Home and Dosing Site Considerations

With the rise in gene therapies entering clinical trials, it is important to address the operational challenges associated with these types of trials.
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Functional Service Models Reimagined: Integrating services and innovation for accelerated clinical development
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