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news.The US Army has granted a multi-year $45m US Army Medical Research Acquisition Activity: Regulatory Affairs & Compliance Support contract to Pharmaceutical Product Development (PPD).
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Under the indefinite delivery, indefinite quantity (IDIQ) contract, PPD will offer global regulatory and biostatistical services for a range of clinical development programs to the US Army.
PPD is expected to support the US Army to prepare and submit clinical trials to the US Food and Drug Administration and other regulatory authorities.
PPD’s quality assurance and medical writing professionals will ensure regulatory compliance for the US Army’s clinical programs and support biodefense, biopreparedness and vaccine development initiatives aimed at protecting military personnel.
The global biostatisticians of PPD are expected to offer statistical consulting, study design and statistical analysis support to US Army.
PPD Global Regulatory Affairs senior vice president Henrietta Ukwu said this contract enables them to deliver on their breadth of global regulatory and biostatistics services and assist the US Army in advancing clinical programs that improve the health of men and women serving in their armed forces.
"We are pleased to partner with the US Army in this effort and to continue to extend our long history of partnering with the U.S. Government on clinical research and development," Ukwu said.