Data Safety Monitoring Boards Facilitate Ethical Research
Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.
What Sponsors Need to Know About Medicare Coverage Analysis
Discover the role of MCA in clinical research, its impact on study activation timelines, and how outsourcing can streamline trials.
Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
Key strategies for successful research study startup: site selection, documentation, and effective initiation.
Key Efficiencies Driven by a Clinical Trial Management System
Find out how sites can get the most value from their clinical trial management system (CTMS) to streamline operations.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.
Beginner’s Guide to IRB Review of IVD Research
If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.
Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Discover how CTMS streamlines patient recruitment & management for successful clinical trials.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
eReg Benefits for Clinical Research: Use Cases for all Types of Sites
Using an eRegulatory system can benefit any site, helping to increase productivity, improve compliance, and save money.