HTA, A New Approach to Temperature Monitoring, and the FDA’s Pre-Cert Program for Digital Health Devices

In this ISSUE

Managing Clinical Trial Complexity as Gene Therapy Progresses

Joint HTA Doesn't Stop Just Because Brussels Talks Are at a Standstill

Primed for Progress: FDA's Pre-Cert Program for Digital Health Devices

Technology

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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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

Supply Chain

A New Approach to Temperature Monitoring in a Changing Clinical Supply Chain Environment

Examining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.
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Calendar

/ IRT Europe 4/16–4/17 /

/ Clinical Research as a Care Option 4/29–4/30 /

/ Clinical Trial Budgeting and Forecasting 4/30–5/1 /

/ 5^th Annual Endpoint Adjudication 5/1–5/2 /

/ MDR Workshop — Transitioning to the EU MDR and Managing Legacy Devices 5/15 /

Standardization Drives Transparency and Optimization of Contract/Budget Processes in Clinical Trial Startup
Tuesday, April 30, 2019 at 1pm EDT | 12pm CDT | 10am PDT

Virtual Monitoring

Virtual Clinical Trials: The Future of Patient Engagement?

Imagine it's 2025. Participating in a clinical trial does not require travel to a clinical research facility or doctor's office. Your mobile device is your link to the clinical research study and how you report general information and adverse events. Sujay Jadhav explores.
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Technology: Friend vs Foe - Considerations for Practical Execution of a Risk-Based Monitoring Strategy
Tuesday, April 23, 2019 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST

UK/EU

Jumping The Gun on Advanced Medicines in Europe

After taking a long awaited step forward in a rare treatment, the impatience of European patient organizations are understandable given the slow emergence of advanced medicines. Peter O'Donnell writes there is good news for patients—just not quite as good as they may have thought.
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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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Patient Centricity

The Evolution of Patient-Centric Technology for Clinical Research

A look at what patient centricity in clinical research means and how it has evolved.
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Fast, Focused Medical Data Review – Use Cases by a Medical Monitor
On Demand

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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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