PPD in China

PPD has been operating in China for more than a decade. With nearly 1,000 employees nationwide, PPD is one of the largest global contract research organizations in the Chinese market to provide end-to-end discovery and development services. Rely on PPD to handle your projects expertly through all stages of the drug discovery and clinical development process in China.

PPD brings you the in-depth therapeutic and project management expertise of a leading global contract research organization combined with a strong working knowledge of China.

Services available in China include:

• Clinical development
  • Clinical management and monitoring
  • Regulatory affairs
  • Biostatistics and data management
  • Pharmacovigilance and medical affairs
  • Global clinical supplies
  • Quality assurance
  • Training 
• Discovery
• Integrated services from discovery to first in human
• Medicinal chemistry
• Library chemistry
• Custom synthesis
• Process chemistry
• Drug metabolism and pharmacokinetic (DMPK) validations
• Discovery biology
• Drug safety evaluation
• Pharmacology
• Global central labs

Clinical Development Services

PPD offers a complete range of clinical development services in China.

Clinical Management and Monitoring

In the last five years, PPD has conducted more than 80 Phase I-IV clinical trials in China, including global multicenter trials, import drug registration trials and bioequivalence studies. These trials encompass a broad range of therapeutic areas, with a primary focus on the following:

• Oncology
• Cardiovascular
• Respiratory
• Endocrinology
• Infectious diseases
• Vaccines

PPD has conducted clinical trials in more than 300 hospitals throughout China. A strong investigator network combined with our in-depth understanding of the unique clinical trial environment in China enables us to provide effective startup strategies that can reduce costs and get your projects on the right track from the start.

Regulatory Affairs

PPD is one of the leading providers of regulatory affairs services in China. Since 2005, we have succeeded in obtaining more than 130 registration approvals from the State Food and Drug Administration (SFDA). These approvals range from global trial applications to the registration and renewal of pharmaceutical products. We have also handled similar filings for medical devices, diagnostics, health care products and cosmetics.

Data Management and Biostatistics

PPD has a strong team of experienced biostatistics and data management professionals in China. As a part of PPD’s global biostatistics and data management departments, our teams in China are equipped with industry-leading clinical trial management and remote data capture technology.

Pharmacovigilance

As a part of PPD’s global medical and safety group, our China team has access to a broad range of clinical surveillance resources. This puts us in the unique position of being able to provide complete pharmacovigilance services in China, for both local and global studies.

Global Clinical Supplies

PPD has a dedicated clinical supplies facility in Beijing that serves all of China. This facility is a fully integrated part of PPD’s global clinical supplies team that provides clients with access to a breadth of services to manage all aspects of clinical supply chain strategy. The comprehensive range of offerings includes:

• Packaging/labeling design assistance
• Inventory management and forecasting
• Expiration date monitoring
• Import/export coordination and final drug disposition through the full life cycle of clinical supplies.