Regulatory strategy considerations for advanced therapies

Diversity Action Plans: regulatory requirements and clinical trial enrollment goals

Developing comprehensive strategies to assess abuse liability/potential of brain-penetrant compounds

Creating a comprehensive drug development plan

Providing regulatory support in China for a new compound

Achieving sponsor goals with efficient end-to-end solutions

The power of real-world data in clinical development and post-market activities

Strategic considerations when planning an externally controlled single-arm trial

Why literature reviews should be a key part of your evidence-generation strategy

Efficiently managing manufacturing and R&D supply chain documentation and technical support writing for cosmetic, personal care and over-the-counter products

The role of Material and Product Support Services (MPSS) at Fortrea

Inflation Reduction Act (IRA): Assessing the implications of Medicare drug price negotiations for drug development sponsors

Digital transformation in market access

Digital transformation is a grand phase—it can cover technological innovation, data and processes and even global organizational change, yet it doesn't have to be a daunting prospect left to those loooknig for systemic change at a company level.

Advanced therapies: The advantage of early and frequent regulatory interactions

Navigating the dynamic regulatory environment in cell and gene therapy development involves a complex and iterative process. 

Addressing challenges of data management for cosmetic, personal care and over-the-counter products

臨床試験規制と CTIS への備えと今後の展望

Stay informed with Fortrea's blog on clinical trials regulation and regulatory updates. Prepare for upcoming changes and ensure compliance in clinical research.