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In this ISSUE

Re-Imagining Integration for Quality Clinical Trials

Jumping The Gun on Advanced Medicines in Europe

Latest in Business and People News
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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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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eClinical
How Social Media is Transforming Pharma and Healthcare
Social media has moved beyond being a fashionable word to one that is drawing renewed attention from the pharma and healthcare industries. The impact that they can have not only on brand perception as well as the increasing interest of the regulators in social media is resulting in this shift.
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Calendar
/ Clinical Research as a Care Option 4/29–4/30 /
/ Clinical Trial Budgeting and Forecasting 4/30–5/1 /
/ 5th Annual Endpoint Adjudication 5/1–5/2 /
/ MDR Workshop — Transitioning to the EU MDR and Managing Legacy Devices 5/15 /
/ 4th Annual Managed Access Programmes and Accelerated Pathways 5/21–5/22 /
/ BIO International Convention 6/3-6/6 /

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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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Drug Safety
FDA Moves to Modernize Drug Review Process
A new CDER "knowledge management" approach will see companies submit applications that can be transmitted to experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.
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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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Patient Participation
Fundamental Changes Required to Realize Benefits of CRAACO
The recent industry-wide focus on widened access to health care, patient-centric approaches, and high-quality care have increased the interest in the concept of clinical research as a care option, Customer Project Manager of Trialbee, Hanne Van de Meek writes.
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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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Patient Recruitment and Retention
Using Technology to Power Up your Patient Recruitment & Retention
CEO of Greenphire, Jim Murphy, shares his takeaways from 2019 SCRS European Site Solutions Summit and illustrates how to further position clinical research stakeholders for success.
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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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