Our Services and Methodology

We’re methodologists with key strengths in data management, pharmacovigilance, and registries, achieving excellence in a variety of clinical services, including

Our clients believe in our high-quality data, validated processes, and proven results. Trust in our high standards.

Methodical Project Management

Our project management strategy is based on three principles: 1) clear lines of communication; 2) time and cost efficiencies; and 3) quality control. We rely on good communication and partnership to start up quickly and complete studies efficiently. We simultaneously manage multiple clinical studies and federal programs, most involving highly distributed project teams. We manage studies from initial requirements gathering and design to ongoing trial maintenance and final submissions. We have well-developed procedures, systems, and project controls, and ensure on-time, on-budget, high-quality service delivery.

Extensive Multidisciplinary Support for the U.S. Federal Government

We provide clinical study and data management support for industry-sponsored regulatory submissions to the U.S. Food and Drug Administration for government entities, including

  • Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority (ASPR/BARDA)
  • Department of Defense (DoD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Complementary and Alternative Medicine (now the National Center for Complementary and Integrative Health, NCCIH)
  • Centers for Disease Control and Prevention (CDC)
  • Uniformed Services University of the Health Sciences (USUHS)
  • Walter Reed National Military Medical Center (WRNMMC)

We also provide quality assurance, safety monitoring, investigator training, process reviews, and scientific portfolio support for

  • U.S. Food and Drug Administration (FDA)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute on Aging (NIA)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.

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