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In this ISSUE

Rare Diseases and Concrete Cases

What Pharma Companies Need to Know About FDA’s New Draft IVD Guidance

Virtual Clinical Trials: The Future of Patient Engagement?

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Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC-MS: Latest Trends and Recommendations
Live Webcast: Tuesday, May 15, 2018 at 11am EDT | 8am PDT 4pm BST | 5pm CEST
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Generational Influence
Millennials and their Impact on Clinical Research
The importance of examining this generation’s influence on the clinical trial value chain.
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Six Strategies for More Accurate Clinical Trial Forecasting & Budgeting
Live Webcasts: Wednesday, April 25, 2018 at 11am EDT
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Regulatory Authorities
FDA Advances Innovative Clinical Trial Designs
To encourage experimentation with more complex clinical trial strategies, FDA plans to launch a pilot program to assess complex studies proposed by sponsors.
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Scientific Advice with Regulators – An Essential Tool in Early Drug Development
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Technology
Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health Care
Building upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.
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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
Live Webcast: Tuesday, April 24 at 11:00am EDT
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Calendar
/ IRT Europe 2018 - Interactive Response Technologies in Clinical Trials 4/10-4/11 /
/ Clinical Trials in Central and Eastern Europe Forum 2018 4/17-4/18 /
/ FDA Advisory Committee Master Class 4/26-4/27 /
/ 4th Annual Endpoint Adjudication 5/1-5/2 /
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Move Your Immuno-Oncology Therapy Forward in 2018 and Beyond
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PV Research Reveals Momentum Towards Cloud and AL
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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

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The Benefits of a Data-driven Approach to Feasibility
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Patient-Centric Complex Trial Design & Site-Less Visits: How Study Design & IRT Can Ease Patient Burdens
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Digital Media
Finding Patient X: The Role of Digital Media in Rare Disease Research
Digital media is becoming a crucial vehicle for finding "Patient X" for rare disease drug trials. Three areas in particular where digital media is helping with the detective work are explored.
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Managing the Placebo Problem in Chronic Pain Studies
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Patient Centricity
#OnePersonCloser for HCP Awareness
Lisa Henderson writes on patient participation and recruitment in clinical trials.
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Achieve Better Early Clinical Development Outcomes - Faster
Use existing global network site relationships for improved early phase quality, costs and timelines
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