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
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
The British government has at last set out its ambitions for cooperation on medicines post-Brexit.
Oracle Pursues mHealth in Clinical Trials
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.
News
ObvioHealth Announces Launch of Mobile Application
Jul 19, 2018
Genstar Capital to Acquire CRF Health
Jul 18, 2018
Noteworthy
FDA Expands Advice on Testing Gene Therapies
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
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.
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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