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

US Clinical Investigator Experience

This data analysis takes a look at how much experience US clinical investigators have.

What is the Actual Number of Active US Clinical Trial Investigators?

Estimates of active US investigators range from about 20,000 to almost 150,000.

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.

ACT TV

Events

eCOA/ePRO 2017

December 13 - 14, 2017
Philadelphia, PA

Clinical Data Disclosure and Transparency

January 30 - 31, 2018
Philadelphia, Pennsylvania

Clinical Trial Budgeting & Forecasting

February 22, 2018
Philadelphia, Pennsylvania

Blogs

FDA Seeks More Effective Clinical Research Oversight

By Jill Wechsler

Investigators aim to increase the efficiency and consistency of FDA’s Bioresearch Monitoring program.

Introspective Approaches Towards Issues Resolution

By Moe Alsumidaie

In this article, Moe will suggest an introspective method that can help clarify situational analysis and resolution.

Utilizing Real-World Data Captured During Commercial Programs

By Tim Davis

In this three-part blog series, Tim Davis takes a 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

Three Steps to A Successful Combination Product Trial

By Cynthia Pritchard, PhD

Sponsors can streamline the design and execution of their clinical trials by following this three-step approach.

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.

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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