Infection Control and Biosafety in Gene Therapy Research
Gene therapy research has moved from the realm of science fiction to mainstream clinical research. The maturation of this field […]
Research Operations
ICH-GCP Guidelines and Research Conducted in the US
When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated.
What’s the Difference Between Right to Try and Expanded Access?
The right to try movement and recent passage of the federal right to try law have renewed public interest in
Clinical Research Acronyms and Abbreviations You Should Know
New to clinical research? Learn the meaning of common industry acronyms and abbreviations including eCRF, IIT, PI, TMF, and more.
Data Collection in Clinical Trials: 4 Steps for Creating an SOP
Learn the necessary steps to create an effective SOP for data collection in clinical trials.
Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know
On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for
IRB Review of Adaptive Design Studies
The popularity of adaptive design in clinical research continues to grow. Adaptive design can be more efficient than traditional study
The Six Characteristics of an NCI-Designated Cancer Center
Learn the key characteristics that all NCI-designated cancer centers have in common.
6 Ways Sponsors Can Improve Feasibility Questionnaires
Creating feasibility assessments can be as frustrating for sponsors as answering questionnaires is for sites. Here’s how sponsors can alleviate these frustrations, according to sites.
Beginner’s Guide to an Electronic Data Capture (EDC) System
This post walks you through the basics of an electronic data capture system, providing a high-level overview of benefits and common functionality.
Deciphering the CRC Career Path: Key Skills and Responsibilities
Wendy Tate, Director of Data Analytics at Forte, explains key skills and experiences sites look for in a clinical research coordinator.
Beginner’s Guide to Clinical Trial Performance Metrics
Basics to help you get started measuring and improving your clinical trial performance.