4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
Consulting
FDA/OHRP Harmonization and Your HRPP Operations
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
Beginner’s Guide to IRB Review of IVD Research
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance, IVDs require careful IRB review preparation.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African
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.
Rare and Orphan Diseases in Regulated Development
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook outlines Tips and best practices for a successful IIT, Post-approval monitoring and clinical project, and Leveraging industry sponsors.