Company will prepare submissions for various regulatory authorities and provide statistical analysis.
PPD will provide global regulatory and biostatistical services for a range of clinical development programs funded by the U.S. Army under a five-year, $45.5 million contract. The goal is to ensure regulatory compliance for Army clinical programs as well as support biodefense, biopreparedness, and vaccine development initiatives to protect military personnel.
The company will help the Army prepare and file clinical trial submissions to FDA and other regulatory authorities worldwide. Also, PPD biostatisticians will provide statistical consulting, study design support, and statistical analysis.
PPD says has delivered clinical support services to global U.S. Government R&D programs for 21 years. It adds that it has collaborated on more than 900 government and public health drug development projects including programs on infectious diseases, vaccines, biodefense, autoimmune diseases, and asthma/allergic diseases.