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
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
Blogs
CRA Remediation Data Demonstrates Skills Improvement in Multiple Domains
In this article, we will demonstrate a methodology that resulted in improving CRA performance.
Right to try Just Won't go Away
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.
News
Greenphire Expands Flexibility of eClinicalGPS
Jun 15, 2018
Latest Business and People News
Jun 15, 2018
Noteworthy
Five Steps to Making Your Clinical Trials Patient-Centric
Companies can utilize the following five tools to set themselves up for a successful trial.
Final Guidance on IRB Written Procedures Issued
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.
Webcasts
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