Peer-Reviewed Articles

To Sign or Not to Sign FDA Form 1572?

By Natalia Buchneva

Exploring that pivotal question for clinical investigators, sponsors, and global CROs.

Does PI Certification Make a Difference?

By Kathryn Rena Hodges, PhD, Duane Akroyd, PhD

Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.

Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development

By Narine Baririan, Pharm. D

There are several pharmacokinetic factors and peculiarities that should be considered carefully when designing and running first-in-human (FIH) studies for monoclonal antibodies.

CISCRP Corner

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.

Patient Input into Leveraging the Healthcare Professional’s Role

The second series of findings from CISCRP's 2017 Perceptions & Insights Study.

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Events

American Pharma Outsourcing Summit

October 02 - 03, 2018
Crowne Plaza Hotel Philadelphia-Cherry Hill

Basket and Umbrella Trials for Oncology

October 17 - 18, 2018
Philadelphia, PA

Crossroads: An Artia Solutions Conference

November 07 - 09, 2018
JW Marriott Nashville, Nashville, Tennessee

Blogs

A Guide to Avoiding the Common Pitfalls of Market Landscaping

By An Nguyen

Comprehensive market landscaping includes disparate data sets from primary and secondary sources and is a time-consuming process that requires domain expertise and commitment.

The Importance of Age Diversity in Clinical Trials

By Ryan Bailey

Age diversity in clinical trials benefits both the patient experience and the success of the trial.

Key Strategies CRA’s Use to Maintain Good Clinical Practices

By Michael Sydes

Michael Sydes outlines some strategies that CRA's can use to maintain good clinical practices.

Noteworthy

Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They Help

By Jeff Lee, Mindy Gruba

This article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.

How to Manage Machine Learning Algorithms in Clinical Trials

By Dr. Basheer Hawwash

Machine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines, and minimizing expenses.

Prioritizing the Patient Voice

By Dana Weiss

AMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.

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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