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.

ACT TV

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

FDA Promotes Surrogate Endpoints, “Seamless” Clinical Trials

By Jill Wechsler

As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.

Global Risk Based Monitoring: An Invite from Oxford and Duke Research

By Lisa Berdan, Carol Knott

CBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.

Mandatory Certification—It’s Time

By Darlene Panzitta

It is time for mandatory certification to be required for everyone involved in a clinical study.

Noteworthy

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.

How to Detect, Manage, and Report Fraud and Fabricated Clinical Research Data

By Lysa Triantafillou

This article examines the ways to detect fraud and data fabrication within a clinical trial.

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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