IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some form of planned modification or revision.
sites
Optimizing Site Initiation Timelines Through Centralized Processes
A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and reducing bottlenecks for efficient site startup.
mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While
Implementing eSource: A Guide for Operations and Technology Roles
Implementing eSource can streamline data collection for research sites, but ensuring data integrity, compliance, and accuracy is essential for successful adoption and reliable results.
How Sponsors and Sites Work Together to Improve Protocol Compliance
Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters by improving collaboration, training, and resource access.
Addressing Industry Challenges: Staff Turnover
Staff turnover in clinical research impacts trial quality and timelines. Addressing this requires focus on workplace culture, career growth, and competitive benefits.
Our OnCore CTMS Vision: Building a Foundation for Success
OnCore’s future vision focuses on cloud-hosted solutions, cross-platform reporting, and SSO, enhancing efficiency and user experience for research sites.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires
Clinical Trial Startup: Insights from the Industry
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology,
The Role of Financial Management and GAAP in Clinical Research
Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall
Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
HRPP staffing is essential for maintaining research ethics, even with sIRB mandates streamlining review processes for multisite studies. Discover key HRPP roles and benefits.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.