Peer-Reviewed Articles

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.

Maximizing Immuno-Oncology Clinical Trial Success

By Luke S. Gill

Cancer immunotherapies require different standards for evaluating their safety and effectiveness. Understanding these standards—and the other major challenges of immuno-oncology studies—is critical to drug development success.

CISCRP Corner

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.

Public Clinical Research Literacy: New Insights

The first series of results from CISCRP's 2017 Perceptions & Insights Study.

ACT TV

Events

American Biomanufacturing Summit 2018

June 14 - August 15, 2018
Hyatt Regency San Francisco Airport, San Francisco, CA

7th Annual Publication and Clinical Trial Transparency

June 20 - 21, 2018
Amsterdam, The Netherlands

American Pharma Outsourcing Summit

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

Blogs

CRA Remediation Data Demonstrates Skills Improvement in Multiple Domains

By Moe Alsumidaie

In this article, we will demonstrate a methodology that resulted in improving CRA performance.

Right to try Just Won't go Away

By Peter O'Donnell

The right-to-try gale is now blowing at full strength in the US and is likely to prove a straw in the wind that could become a haystack.

AACR, ASCO Bring New Insights to Liquid Biopsy

By Andy Collard

Liquid biopsy, typically non-invasive blood-based tests for circulating tumor DNA and circulating tumor cells, has been long-hyped as a potential game-changer for cancer treatment.

Noteworthy

Five Steps to Making Your Clinical Trials Patient-Centric

By Rosamund Round

Companies can utilize the following five tools to set themselves up for a successful trial.

Final Guidance on IRB Written Procedures Issued

By Ann Begley, Hilary Lewis

The Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.

As Clinical Trials Go International, Operations Go Digital

By Mike Novotny

As international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together.

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.

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