Peer-Reviewed Articles

Barriers and Solutions to Smart Clinical Program Designs

By Mary Banach, Hon-Sum Ko, Steven Hirschfeld, Maria Benjegård, Ian Fisher, Mitra Rocca, Rashedul Hasan, Kerstin Forsberg, Dale Plummer, Courtland E. Yockey, Johann Proeve, Laszlo Vasko

How the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."

Researchers Conduct NH Studies for Rare Diseases and Drug Development

By Thomas Ogorka, Gajendra Chanchu

The use of Natural History studies in order to examine a rare disease that will help facilitate drug development programs.

Monitoring Temperature Control Throughout IMP Supply Journey

By Richard Segiel

How a single-source temperature management strategy can support a drug’s quality and integrity in transit—a process as important as the destination.

Comply with ICH E6 (R2)

The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
 

The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
 

Read more.

Data Analysis

Industry-Sponsored Phase III Clinical Trial Activity

Published data indicate the size and complexity of these Phase III studies has hardly changed over the last few years.

Pinpointing Phase III Trials in Emerging Countries

Most clinical trial activity for Phase III trials takes place in the traditional North American and European markets.

How Important is Big Data?

Survey collects thoughts from industry professionals on the current and future impact of big data in clinical trials.

ACT TV

Events

Partnerships in Clinical Trials Europe

November 28 - 29, 2017
Amsterdam RAI Exhibition and Convention Centre, Amsterdam, Netherlands

BioPharma Forum on Cannabis-Based Therapies

November 30 - December 01, 2017
Embassy Suites, Denver, Colorado

Clinical Trial Legal and Contracting Forum

December 05 - 06, 2017
Philadelphia, PA

Blogs

"There's a Divinity That Shapes Our Ends…"

By Peter O'Donnell

The decision of where to move the EMA was determined by a coin toss.

Methods for Clinical Trial Issues Identification and Resolution

By Moe Alsumidaie

In this article, we will define a process on how to identify, diagnose, correct, and resolve issues in a QMS issues management repository.

Generating a Rich Source of Real-World Data Through Pragmatic Trials

By Tim Davis

In this three-part blog series, we look at how electronic platforms can support and enhance data capture in several types of RWD programs: observational studies, pragmatic trials, and commercial programs.

Noteworthy

Latest Business and People News

By Applied Clinical Trials Editors

Updated employee announcements, business news, awards, and recognition in the industry today.

Beyond RBM: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance

By Steve Young

Steve Young looks at the tremendous benefits that organizations stand to reap by effectively implementing the core principles included in the ICH update and the significant opportunities that the application of intelligent analytics and centralized statistical monitoring may present.

The Risk Based Monitoring Plan

By Ashok Ghone, PhD

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.

eBooks

Clinical Trials for Rare Diseases

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.

View all eBooks

 

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