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

Preparing and looking ahead for the Clinical Trials Regulation and CTIS

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