Patient Centricity —The Evolution of Technology and How Virtual Clinical Trials Could be the Future of Patient Engagement

In this ISSUE

The Evolution of Patient-centric Technology for Clinical Research

Framework for FDA's Real-World Evidence Program

Virtual Clinical Trials: The Future of Patient Engagement?

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

The European Parliament and the Council on clinical trials on medicinal products for human use repealed clinical trials Directive 2001/20/EC and adopted a new regulation. It aims are to bring harmonization of European Union clinical trial multi-country applications and reporting processes, shorten approval timelines, and simplify safety data reporting requirements.
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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

Risk-Based Monitoring

The Risk Based Monitoring Plan

Sponsors and CROs are looking into implementation of a Risk-Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.
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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 /

RBM Case Studies: How Artificial Intelligence and Machine Learning with Advanced Analytics are driving new levels of patient safety and study quality
Thursday, March 28, 2019 at 11am EDT

mHealth/Wearables

How Social Media is Transforming Pharma and Healthcare

The power and impact that social media can have on brand perception, and on sales, as well as the increasing interest of the regulators, is drawing renewed attention from the pharma and healthcare industries.
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Fast, Focused Medical Data Review – Use Cases by a Medical Monitor
Wednesday, March 27, 2019 at 11am EDT| 8am PDT| 3pm GMT| 4pm CET

Clinical Operations

The Basics of Clinical Trial Centralized Monitoring

Since publication of the regulatory guidance on risk-based monitoring five years ago, the concept of CM has developed amid the emergence enablers that make clinical research more data-driven than ever before. Today, regulators encourage the use of CM in conjunction with on-site monitoring.
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Minimizing the Impact of Human Error, Subjectivity, and Labor Costs
The Application of Digital Pathology in Clinical Trials
On Demand

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Trial Management

How Does GDPR Affect Clinical Trials?

The aim of the GDPR is to standardize and strengthen the protection of personal data across the EU and for other country's data being "processed" within the EU. This is an issue for all to take note, not just those based in Europe.
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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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