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.
Sponsor
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.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Regulatory Pathways: When to Submit a 505(b)(2) or an ANDA
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Empowering Patients Through Education and Advocacy in Cancer Care
In the evolving landscape of healthcare, the role of the patient has shifted from a passive recipient of care
The IND Journey Phase I – Navigating Success
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
The Clinical Development Plan: Executing the Clinical Strategy
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
Didn’t Expect That to Happen: Events That Must be Reported Promptly to the IRB
Learn what events need to be reported to the IRB after study approval and explore scenarios to help evaluate potentially reportable events.