Gov/NGO PharmaServices

Meet the complex challenges of managing domestic and multinational clinical trials with the customized and flexible approach of PPD’s Gov/NGO pharmaservices team. We specialize in multinational Phase I-III clinical trials under government contract and NGO requirements.

A Team of Experts Delivering Global Services

Our gov/NGO pharmaservices team has monitored more than 200 protocols in multiple disease indications in Africa, Latin America and Asia, including:

• HIV therapeutics
• Vaccine research
• Clinical biodefense experience

To address the challenges of working in these infrastructure-constrained settings, the gov/NGO pharmaservices team has developed unique clinical trial resources, including:

• Site evaluation, capacity planning and site management
• Established relationships with investigators and efficient patient recruitment
• Multinational regulatory strategies
• Leading-edge technology supporting information flow and communications among clinical teams and investigative sites
• Quality assurance and training focused on improving the quality of research at the site level with customized, client-specific programs and systems assessments

HIV Development Initiatives

For more than 12 years, our gov/NGO pharmaservices team has managed domestic and multinational HIV clinical programs under government contracts. Our customized client-specific development and training programs focus on International Conference on Harmonisation (ICH), good clinical practice (GCP) and U.S. federal regulations and guidances as well as continuing medical education (CME) credits for site staff.

Vaccine Research

PPD has monitored a vast scope of protocols for vaccines, including more than 200 bacterial and viral vaccine protocols for the National Institutes of Health (NIH) at vaccine treatment evaluation units across the United States. Worldwide, the gov/NGO pharmaservices team has experience staging field-based vaccine studies in targeted populations with HIV, malaria and tuberculosis.

U.S. Government Contract Experience

PPD is experienced with U.S. government prime and subcontracting models. The gov/NGO pharmaservices team conducts numerous trials under a variety of government contract types and is well-versed in federal acquisition regulations (FAR) adherence.

Biodefense Experience

Recent world events have led to increased biodefense programs, including smallpox vaccine development. PPD understands the complexities and unique challenges of this relatively new and expanding therapeutic area. Since 2000, the team has monitored numerous Category A biodefense protocols.