In the News

PPD’s Brittany Erana discusses how clinical teams should be responding to the impact of technology and its use post-COVID-19 to improve the clinical patient experience.

Regulatory affairs experts Ilse-Maria Nolan and Aneta Tsolovska discuss the role regulatory intelligence functions have played in developing decentralized clinical trials strategies that have helped maintain continuity during the pandemic.

The authors provide an overview of the more common models that can be deployed for the outsourcing of regulatory services.

The authors discuss how a submission can be both exciting and daunting, from the initial discovery at a lab to first in-human testing to the completion of Phase III program.

Over the past 30+ years, the PPD® Laboratories Bioanalytical Lab has helped bring thousands of compounds to market and the company continues to invest and expand its facilities to meet the ever-increasing needs of customers.

Debra A. Schaumberg and K. Jack Ishak investigate the considerations needed for use of RWE for construction of external comparators to support regulatory decisions.

The PPD authors discuss how the assessment of pain and pain relief is challenged by the complexity of the medical presentations, the subjective nature of the measurements and the desire to have a single solution to demonstrate efficacy in our evidence-based regulatory environment.

William Bakewell and Marc Wolman of PPD® Laboratories’ GMP lab discuss how the structure and activity of complex biotherapeutic molecules require sensitive analytical technologies.

The authors explain how high throughput molecular biomarker technologies combined with bioinformatics have been successfully used to assess infectious agents.