Archives: Resources
Addressing Key Challenges in the Clinical Development of Combination Immuno-oncology Therapies
This case study illustrates real-world challenges and subsequent key learnings in a global I-O combination program.
Improved risk management: benefits of predefined quality tolerance limits
PPD has established a robust and well-integrated, cross-functional process to help its sponsors
execute the QTL component of ICH E6 (R2).
Early development and clinical pharmacology solutions brochure
PPD’s early development and clinical pharmacology solutions allow clients to maximize value in their early stage portfolios.
Outsourcing regulatory lifecycle management: drivers, challenges and considerations
This paper discusses delegating responsibility for effective planning and delivery of lifecycle management of global marketing authorizations
Integrated approach to clinical management and central lab services
This paper explores PPD’s operating model, which incorporates lab strategy within the clinical development process.
Innovative technology provides seamless data integration
This paper discusses efficiencies that can be achieved using an automated platform that integrates patient data and central laboratory data.
Updating research, development and regulatory models for gene therapy
This e-book offers perspectives on how to ensure a smoother pathway to commercialization for cell and gene therapy.
GMP lab publications on inhaled pharmaceuticals
Our GMP scientists have chosen a few of their presentations and publications to share with you.