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In this ISSUE

The Changing Landscape for Clinical Trial Sites

Proliferation of Rare Disease R&D Necessitating Novel Strategies

No End in Sight to European Debates About Drug Firms' Influence on Regulators

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Study Start-up
The VA Gets Real on Reform
After years of siloed focus–and slow study start-ups–the U.S. Veterans Affairs agency embarks on implementing its multi-year initiative to bolster clinical research.
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Exclusive Video from DIA:
Watch Michael Keens and Lisa Gorman from Firma Clinical Research discuss patient support related changes in the industry, common questions from sponsors and CROs, and exciting things that will benefit the drug development community.
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Q&A
Overcoming the Complexities of Neurodegenerative Clinical Trials
COO and CMO of BrainStorm, Ralph Kern, discusses how his company is overcoming challenges and advancing science in neurodegenerative disease.
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Trends and Insights for Your Oncology Trial: Trends and Insights for Your Oncology Trial
Tuesday, November 12, 2019 at 10am EST
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Calendar
/ Rare Diseases & Orphan Products Breakthrough Summit – 10/21-10/22 /
/ eCOA/ePRO 2019 – 10/29 /
/ 9th Annual Interactive Response Technologies in Clinical Trials – IRT 2019 –10/29-10/30 /
/ Risk-Based Trial Management and Monitoring –11/13-11/14 /
/ Clinical Trial Legal and Contracting Forum – 12/10–12/11 /

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Launching Medical Devices in the Japanese Market
- How to navigate regulatory and reimbursement approval

Thursday, October 31, 2019 at 11am EDT
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Opinion
Fighting High Prices for Innovative Drugs with State-Owned Generic Production
A strongly-worded plan for reining-in profit-driven drug firms receives immediate backlash as arguments over drug pricing and patient access continue to rage around Europe and the U.S.
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Will Decentralized Clinical Trials Compound Patient and Data Quality Risks?
Tuesday, October 29, 2019 at 1pm EDT | 12pm CDT| 10am PDT
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From the Editor
Taking Care of Site Business
A view of highlights and trends from the September 2019 issue, alongside trends mentioned around site practices during the year.
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GrantPlan: Create Grant Budgets with Confidence and Accuracy
Thursday, October 10, 2019 at 11am EDT
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Industry News
Latest in Business and People News
The latest happenings of the past month in the industry, all in one place.
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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
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Ask the editor
Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
tbaker@mmhgroup.com

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How AI/ML and advanced techniques are enhancing clinical development
Lessons learned from use in study design, patient and site ID, safety, and risk-based monitoring
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Successful Early Phase Drug Development of mAb Drugs
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