Improving Study Activation Time for Gene Therapy Research
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs as part of overall study activation time.
Research Operations
Data Safety Monitoring Boards Facilitate Ethical Research
In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant
Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
The study startup process is a critical point in research, and oftentimes, can make or break a study’s success.
Key Efficiencies Driven by a Clinical Trial Management System
In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
Beginner’s Guide to IRB Review of IVD Research
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance, IVDs require careful IRB review preparation.
Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Effective participant recruitment is crucial to a successful clinical trial, and as trials become more complex, the problem is intensifying.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular
How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
While regulatory management takes time and effort, using an eRegulatory system can help staff boost productivity, improve compliance, and save resources.