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Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.
Read moreGxP Audits Guide for Successful Clinical Trials
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.
Impact of sIRB Mandates on Study Teams
Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...
Strategic Training: Navigating Organizational Challenges
It’s important to define what falls into training and what doesn’t. The key is to know what the training is intended to accomplish.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Planning for Complex Change at Your Organization
Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
The Value of Continuity: Program-level DSMBs
Using a single DSMB for an entire therapeutic program ensures continuity of experience and offers potential cost savings and efficiency gains.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
Checklist to Reduce Burden on Sites and Patients
Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.
Enhancing User Experience, Security, and Compliance with Single Sign-on
As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.