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

Rare Diseases & Orphan Products Breakthrough Summit

October 15 - 16, 2018
Marriot Wardman Park, Washington, D.C.

Basket and Umbrella Trials for Oncology

October 17 - 18, 2018
Philadelphia, PA

Blogs

FDA Supports Streamlined Trials for New Antimicrobials

By Jill Wechsler

The critical need for new medicines to combat infectious diseases is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to promote innovation in this area.

The European Union Guessing Game

By Peter O'Donnell

The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it.

Vendor? Strategic Partner? The CRO’s Evolving Role in Clinical Trials

By Krista Armstrong

Krista Armstrong explains the CRO's evolving role within clinical trials.

Noteworthy

Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia

By Nurul Atiqah Abd Rahman, Norafizaa Yusop

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.

Leveraging a Unified Data Model to Drive Collaboration and Clinical Trial Efficiency

By Elisa Cascade, Claire Sears, PhD

This article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.

Why Data Integrity Should be an Integral Part of the Pharma Biotech Industry Culture

By Olive McCormick

Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.

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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