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PPD in the News

Applied Clinical Trials (September 2021)

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.

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PharmaVOICE (September 2021)

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.

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Regulatory Rapporteur (September 2021)

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.

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Pharma Focus Asia (August 2021)

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.

Applied Clinical Trials (August 2021)

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.

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Regulatory Focus (July 2021)

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.

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Regulatory Rapporteur (July 2021)

Measuring mild-to-moderate acute pain – A regulatory perspective

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.

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Pharmaceutical Technology (July 2021)

Complex biomolecules require analytical evolution

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

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European Biopharmaceutical Review (July 2021)

Spearheading the fight against infectious diseases and emerging outbreaks

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

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