The Obstetric-Fetal Pharmacology Research Centers (OPRC) are poised to provide a mechanism to further the investigation of safety, efficacy, pharmacokinetics and pharmacodynamics in therapies for common pregnancy-related conditions and outcomes (e.g., preterm labor, preeclampsia, gestational diabetes) as well as prevalent conditions that are not necessarily associated with pregnancy (e.g., depression). Potential OPRC studies include basic research in animal, cell, tissue and organ-based systems and clinical research, such as PK, PD and pharmacogenetic (PGx) studies of FDA-approved drugs, identification of reliable biomarkers and assays to aid detection and monitoring of anomalies, and development of novel therapeutic agents. All are critically needed to better understand the effect of drugs during pregnancy and postpartum and subsequently develop tools to improve timely detection, on-going monitoring and disease management. Networks with interdisciplinary investigation require tools to optimize interoperability, speed and quality of their collaborative endeavors. A Logistic Coordinating Center (LCC) will be established as part of the OPRC recomplete to address these challenges and is vital to the success of the OPRC program's overarching mission. DM-STAT, Inc. is well-positioned to successfully fulfill this role and will effectively serve as the LCC of the OPRC by accomplishing the following specific aims:
Specific Aim 1 : To develop systems and processes to support multi-disciplinary collaboration, communication and information exchange to ensure that the research priorities are transparent and subsequently the goals of the OPRC program are met.
Specific Aim 2 : To ensure all studies and trials of the program are executed ethically and in accordance with applicable local, state and federal regulations, institutional requirements and industry best practices. If awarded, DM-STAT will play a pivotal role in ensuring success of the OPRC program, utilizing tools developed and knowledge acquired over the past 18 years serving network projects of similar size and scope. DM-STAT recognizes the importance of understanding the scientific content of multidisciplinary investigations in order to serve as active and informed contributors. DM-STAT has built a solid foundation in maternal and child health research, particularly in obstetrics, and keeps abreast of developments in the field, such as the investigation of changes in the PK/PD, microbiome, (epi)genetics, placental function and other factors affecting maternal health, fetal development and pregnancy outcomes. In the role of the LCC in the OPRC, DM-STAT will be instrumental in the effective institution and management of the program's infrastructure and ensuring regulatory compliance, enabling timely dissemination and translation of research findings, to ultimately protect the health of pregnant women, while improving birth outcomes and reducing infant morbidity and mortality.
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