In the News
Next-gen lab services
PPD subject matter experts share insight on the flexible space and services next-generation laboratories require.
Bioanalytical studies support biosimilars approval pathway
Immunochemistry leaders from PPD® Laboratories Bioanalytical Lab discuss the need for and importance of bioanalytical assays in the development of biosimilars.
Rebadging gains momentum amidst COVID
The authors discuss the benefits and challenges of rebadging for companies that perform clinical trials and other pharmaceutical/biotech services.
The evolving patient journey
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.
Decentralized clinical trial adoption: Lessons learned from the pandemic
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.
Current trends in regulatory outsourcing models
The authors provide an overview of the more common models that can be deployed for the outsourcing of regulatory services.
Data integration strategy: The cornerstone of a successful regulatory submission
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.
Facilitating bioanalytical studies
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.
Considerations for regulatory application of RWD-generated external comparators
Debra A. Schaumberg and K. Jack Ishak investigate the considerations needed for use of RWE for construction of external comparators to support regulatory decisions.
