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In this ISSUE

FDA Moves to Modernize Drug Review Process

Fundamental Changes Required to Realize Benefits of CRAACO

Proscia Launches Commercial Research Edition of Digital Pathology Platform

Therapeutic Specific Areas
Nasal Spray Research Moves to Social Anxiety Disorder
Dr. Mark Smith, Chief Medical Officer of VistaGen Therapeutics, sits down with Moe Alsumidaie to discuss the challenges of modern psychiatric clinical trial design and implementation and their neuroactive pherine, PH94B.
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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
Europe: Thursday, June 6, 2019 at 3pm BST | 4pm CEST
North America: Thursday, June 13, 2019 at 11am EDT | 10am CDT | 8am PDT
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Clinical Trial News
Latest in Business and People News
The latest happenings in Clinical Trials. Find out who's been promoted, appointed, and much more.
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Calendar
/ 4th Annual Managed Access Programmes and Accelerated Pathways 5/21–5/22 /
/ BIO International Convention 6/3-6/6 /
/ 8th Annual Publication and Clinical Trial Transparency Europe – 6/11-6/12 /
/ Rare Disease Innovation and Partnering Summit – 6/13-/14 /
/ DIA 2019 Global Annual Meeting – 6/23-6/27 /

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RBM Case Studies: How Artificial Intelligence and Machine Learning with Advanced Analytics are driving new levels of patient safety and study quality
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Refocusing on Risk Mitigation in Starting Clinical Trials
Tuesday, May 28, 2019 at 1pm EDT | 12pm CDT | 10am PDT
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Nonadherence
Understanding the Statistical Implications of Undetected Risk
Nonadherence in clinical trials plays a significant role in influencing the quality of data, trial results and, subsequently trial cost and duration. It may stem from unintentional drivers, such as forgetfulness, poor organizational skills, protocol regimen complexity, or experiencing an Adverse Event.
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Challenges in Biosimilar Bioanalytical Assays and Sample Processing
Tuesday, May 21, 2019 at 2:30pm IST | 5pm CST | 6pm JST
Wednesday, May 15, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Risk Based Monitoring
A Roadmap for Implementing Risk-Based Monitoring and Quality Management
Integrating a systemic risk management strategy for identifying clinical trial risks–and the importance of applying change management techniques throughout the preparation, planning, and execution stages.
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Standardization Drives Transparency and Optimization of Contract/Budget Processes in Clinical Trial Startup
Tuesday, April 30, 2019 at 1pm EDT | 12pm CDT | 10am PDT
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Weaponizing Cancer as a European Election Pledge
Peter O'Donnell writes about Manfred Weber's announcement of what he called "his European Master Plan against Cancer" – with what he termed "a guarantee" for European citizens, taking political lobbying over health to a new level in Europe
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Technology: Friend vs Foe - Considerations for Practical Execution of a Risk-Based Monitoring Strategy
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Ask the editor
Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
todd.baker@ubm.com


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