DSMB Best Practices and Behind the Scenes Insights
Ensure your DSMB meets regulatory standards. Learn best practices in administration, member selection, and overcoming challenges in clinical trial oversight.
Sponsor
Sponsors: Are Your Sites Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
What Happens When a Study Fails to Meet Its Recruitment Targets?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Best Practices for IRB Review of DCTs: Expert Perspectives
A variety of distinctive ethical, regulatory, and legal challenges stand in the way of greater adoption of decentralized clinical trial (DCT) components and study designs.
Inspection Readiness: Before, During, After
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
An inspection readiness program can assess compliance, address deficiencies, and prepare sponsors and CROs for potential FDA inspections.
What Sponsors Need to Know About Medicare Coverage Analysis
With MCA processes slowing trial activation, AACI suggests sponsors play an active role in MCA preparation to reduce budget and startup delays.
Navigating Key Complexities in the Development of Cell and Gene Therapies
Discover how biotech organizations navigate the unique challenges of cell and gene therapies, from regulatory shifts to recruitment and market uncertainty.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Find out what researchers should consider in selecting and using these technologies and how to adequately inform participants of the potential risks.
Is Your Site Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
How to Optimize Your sIRB Experience
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.