Wilmington, N.C.-based CRO PPD has been awarded the U.S. Army Medical Research Acquisition Activity: Regulatory Affairs & Compliance Support contract to provide global regulatory and biostatistical services for a range of clinical development programs funded by the U.S. Army.
The award is a multi-year, indefinite delivery, indefinite quantity (IDIQ) contract with a ceiling value of $45.5 million over a five-year period as of April 15. PPD brings its operational regulatory capacity, regulatory affairs consulting expertise and an in-depth understanding of global regulatory requirements and submission strategies to aid the U.S. Army in preparing and filing clinical trial submissions to the FDA and other regulatory authorities worldwide.
PPD will provide quality assurance and medical writing to ensure regulatory compliance for the U.S. Army's clinical programs and support biodefense, biopreparedness and vaccine development initiatives aimed at protecting military personnel. It also will provide statistical consulting, study design and statistical analysis support.
"This contract enables us to deliver on our breadth of global regulatory and biostatistics services and assist the U.S. Army in advancing clinical programs that improve the health of men and women serving in our armed forces," said Henrietta Ukwu, M.D., senior vice president of global regulatory affairs for PPD. "We are pleased to partner with the U.S. Army in this effort and to continue to extend our long history of partnering with the U.S. Government on clinical research and development."
PPD has delivered global clinical support services to U.S. government R&D programs for 21 years. The company has collaborated on more than 900 government and public health drug development projects in infectious diseases, vaccines, biodefense and autoimmune and asthma/allergic diseases.