Noteworthy

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

By Esther Sadler-Williams, Nimer Yusef, Gary Cunnington, Samantha Carmichael, Rebecca Stanbrook, Martin Peter

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.

The Patient Perspective on Clinical Trials: Survey Results and Industry Implications

By Lindsey Wahlstrom-Edwards, Anne-Marie Hess

A study conducted by Antidote Technologies and SCORR Marketing looks at what patient centricity means in clinical trials and the work that remains to realize the potential for better study designs.

Framework for FDA’s Real-World Evidence Program

By Beth Schurman

The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements.

CISCRP Corner

Sharing Stories of Clinical Trial Participation from Start to Finish

How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.

Patient Experiences with Clinical Trial Medicines and Instructions

Providing easy to understand and culturally appropriate investigational medication education and support can make all the difference in improving the patient experience.

Patient Perspectives on Seeing Trial Results

The third in a series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.

ACT TV

Events

IRT Europe

April 16 - 17, 2019
London, England

Clinical Research as a Care Option

April 29 - 30, 2019
Raleigh-Durham, NC

Clinical Trial Budgeting and Forecasting

April 30 - May 01, 2019
Philadelphia, PA

Blogs

European Researchers Struggle to Communicate

By Peter O'Donnell

A statement from Europe's drug industry and medical societies calls for adequate funding for translational research, explaining the importance, and highlighting the challenges it faces.

The Evolution of Patient-centric Technology for Clinical Research

By Jackie Kent

A look at what patient centricity in clinical research means and how it has evolved.

Transitioning from a Risk-Based Monitoring Approach to Risk-Based Quality Management

By Patrick Hughes

What started as an initiative called Risk-Based Monitoring several years ago is now evolving into Risk-Based Quality Management of clinical trials with a much wider impact to the pharma industry.

Peer-Reviewed Articles

Portfolio Approach to Optimize Site Selection

By Vadim Paluy, MD, Vladimir Shnaydman, PhD

Site selection is one of the most important and at the same time challenging problems in clinical trials planning. Poor site selection may cause enrollment delays, resource waste on low or zero enrollment, and even potentially compromise trial results.

Analytics and Metrics Help Pinpoint Costs of Study Startup

By Craig Morgan

Using data analytics to introduce parallel processes to optimize and accelerate clinical trials.

The Basics of Clinical Trial Centralized Monitoring

By Adam Beauregard, Vadim Tantsyura, Fernand Labrie

Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.

eBooks

Outcomes in Focus: Best Practices for eCOA

This eBook on Outcomes in Focus: Best Practices for eCOA covers considerations and practical advice for smooth eCOA implementation; secrets to eCOA success from industry insiders; and new opportunities for the use of eCOA in clinical trials.

View all eBooks

 

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