Peer-Reviewed Articles
To Sign or Not to Sign FDA Form 1572?
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
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.
ACT TV
Events
Crossroads: An Artia Solutions Conference
November 07 - 09, 2018
JW Marriott Nashville, Nashville, Tennessee
Blogs
FDA Promotes Surrogate Endpoints, “Seamless” Clinical Trials
As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.
Global Risk Based Monitoring: An Invite from Oxford and Duke Research
CBI, the conference group sister of Applied Clinical Trials, is featuring their Global Risk Based Monitoring Conference in September.
Mandatory Certification—It’s Time
It is time for mandatory certification to be required for everyone involved in a clinical study.
News
Latest Business and People News
Aug 16, 2018
VIARES Changes the Standards for Entry-level CRAs
Aug 15, 2018
Noteworthy
How to Manage Machine Learning Algorithms in Clinical Trials
Machine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines, and minimizing expenses.
Prioritizing the Patient Voice
By Dana Weiss
AMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.
How to Detect, Manage, and Report Fraud and Fabricated Clinical Research Data
This article examines the ways to detect fraud and data fabrication within a clinical trial.
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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