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 Pharma Outsourcing Summit

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

Crossroads: An Artia Solutions Conference

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

Crossroads: An Artia Solutions Conference

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

Blogs

Patient Value Creation & Pharmaceutical R&D Prioritization

By James Man

James Man considers the practical measures firms can take to embed the patient perspective more directly into their R&D planning.

European Healthcare Confronted with a Brexit Mouse

By Peter O'Donnell

The British government has at last set out its ambitions for cooperation on medicines post-Brexit.

Oracle Pursues mHealth in Clinical Trials

By Moe Alsumidaie

In this interview, Jim Streeter, Global Vice President of Life Sciences Product Strategy at Oracle, will elaborate further on Oracle’s strategy with mHealth in clinical trials.

Noteworthy

FDA Expands Advice on Testing Gene Therapies

By Jill Wechsler

The potential for innovative gene therapies to treat and even cure a range of serious diseases is prompting FDA to ramp up support for developing and testing new products efficiently and effectively.

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.

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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