The Importance of Keeping DSMBs Independent
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
Research Compliance
Beginner’s Guide to Connected Clinical Research Ecosystems
A well-managed, participant-centric clinical trial has many moving parts, and easy access to the right technologies, services, and community of
Beginner’s Guide to Compliant Electronic Source Data Capture
While electronic source data collection is not new, collecting source data in a variety of settings in a compliant manner is. With this in mind, how does one maintain data quality and integrity while ensuring participant safety and staying compliant?
Understanding International Data Transfer’s Impact
The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate.
Data Integrity – It’s All About the Data!
In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data
6 Tips for Creating Effective Clinical Trial Training
Effective training for clinical trials requires clear, engaging content tailored to busy site staff. Focus on bite-sized learning, mobile optimization, and learner feedback.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.
Beginner’s Guide to Minimal Risk Research
When an institutional review board (IRB) determines research is “minimal risk” (as defined in Department of Health and Human Services
4 Key Integrations for Your Clinical Trial Management System
In this blog are some key CTMS integrations — using systems your institution has likely implemented — your team can use to streamline research operations.
IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Read about IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance.