Answering Questions About RBM & Drug Development

In this ISSUE

What is the Right "EASY Button" Approach for Research Oversight and RBM?

The Future of Clinical Development is Here: Research in MicroOrgans

The Cancer Trial Paradox – Too Few Patients to Some, Too Few Trials to Others

Precision Medicine

What's Next for Drug Validation in the Age of Precision Medicine?

The case for evaluating drugs with real-world digital health data.
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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
North America: Thursday, June 13, 2019 at 11am EDT | 10am CDT | 8am PDT

Drug Development & Reporting

GlaxoSmithKline Tackling Data Challenges to Streamline Drug Development

At some point in every organization's life, they come to realize that their data environment isn't set up for success. Adrian Cottrell, PhD, VP of clinical, medical, and regulatory tech for GlaxoSmithKline writes about when his company came to that very conclusion in 2017.
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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
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Calendar

/ DIA 2019 Global Annual Meeting – 6/23-6/27 /

/ 2^nd Annual Direct–to–Patient Clinical Trials – 8/8-8/9 /

/ T3: Trials, Tech, and Transformation — 8/8-8/9 /

/ 3^rd Annual Medical Writers Summit — 9/25–9/26 /

/ 4^th Annual Lay Summaries Summit — 9/25–9/26 /

A new way to assess changes in trial complexity, success and duration: The Clinical Development Productivity Index
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Challenges in Biosimilar Bioanalytical Assays and Sample Processing
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Registries in Europe

How Fast is Europe Filling in the Gaps Identified in Its Rare Disease Networks?

Peter O'Donnell writes of the European Commission's recently published reports suggesting that some of the gaps were being filled in registries in the field of rare diseases.
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COPD – Tackling the Unmet Needs
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Risk-Based Monitoring

Tackling the Challenges of Transitioning to Risk-Based Monitoring

Crystal Stone and Amanda Coogan of Remarque Systems discuss how an RBM approach can help enhance the safety and efficiency of clinical trials.
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Refocusing on Risk Mitigation in Starting Clinical Trials
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Adoption & Implementation

New Survey Measures the Pulse of RBM & ICH-E6 (R2) Adoption in the Clinical Trials Industry

Abby Abraham, Vice President, Data Analytics, and RBM for OmniComm Systems, writes about a new survey that highlights gaps in the conversation surrounding the industry's adoption and implementation of risk-based approaches to monitoring.
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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

Challenges in Biosimilar Bioanalytical Assays and Sample Processing
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