In the News
Clinical Trial Information System: Overview, opportunities and challenges
Regulatory affairs experts from PPD clinical research services provide an overview of the EU’s new Clinical Trial Regulation 536/2014 and Clinical Trial Information System.
Resourcing drug trials can be done in many ways. Which one is right for you?
Les Enterline and Timothy King outline the advantages and disadvantages of today’s most popular staff sourcing models as they apply to pharma companies.
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.