How We Remain Preferred Clinical Partners for U.S. Federal Agencies

Navitas Clinical Research (a part of Navitas Life Sciences) is a trusted partner to the US Federal Government, non-profits & academia for clinical study management. We create immense clinical trial value, laying out strategic imperatives, that help run efficient clinical trials.

Our ability to craft clear goals and clarify strategies have helped us manage early through late phase clinical trials and registries & other observational studies for over 30 years. Our clients span the range of US Federal Government institutes and non-profits.

Navitas Clinical Research’s Support

  • Identification, qualification, and activation of clinical sites
  • Site management and communications
  • Clinical site monitoring, including initiation, interim, central, remote and for-cause visits
  • Site audits, including prequalification, and mock FDA audits

Robust Operating Strategies to Drive Faster and Efficient Impact

We support diverse clients with the design, execution, and result in the analysis of their observational studies, registries and clinical trials. We have helped bring innovative drug treatments, medical devices, and other interventions to market since 1986.

Our decades of experience enable us to predict needs, avoid common barriers, and move from a quick start-up through each research phase to successful execution of your project

How Navitas Clinical Research Drives Greater Value To Clinical Trials

To understand how Navitas Clinical Research found its strategic footing and helped support numerous U.S. Federal agencies, we took the time to interview Dr. Yun Lu, Chief Operating Officer and VP of Data Management & Standards, Americas.

Tell us a bit about your professional background

I have over 20 years of clinical data experience and am responsible for the overall development efforts of the Clinical Data Management and Standards team. I oversee the analysis, design, implementation, testing, documentation, and support for end-user applications and eClinical solutions. I lead efforts to incorporate CDISC into the electronic data capture system and submission to FDA and development of therapeutic/disease specific CDEs.

Dr. Yun Lu, PhD

Chief Operating Officer and VP of
Data Management & Standards, Americas
Navitas Clinical Research
(a part of Navitas Life Sciences)

I received my Bachelor of Science degree from NanKai University, China. I received my Ph.D. degree in Biophysics/Biochemistry from The Medical College of Ohio in 1996. I was a postdoctoral researcher at the University of Pennsylvania School of Medicine from 1997 to 1998 and was a postdoctoral fellow at the National Institute of Diabetes and Digestive and Kidney (NIDDK) National Institute of Health (NIH) from 1999 to 2000.

Please give us a glimpse of your role at Navitas Clinical Research

As Navitas Clinical Research’s Chief Science and Innovation Officer, I take an active role in planning, directing, reviewing and implementing all aspects of organization’s strategic objectives, clinical research implementation, business development, and policies/SOP development and implementation. I also lead proposal development and participate in bid defenses, and contribute to the company’s long range planning and strategic planning processes.

Describe your journey supporting U.S. Federal clinical trials

My first clinical trial experience at NCR (previously KAI) was supporting NIH National Institute on Drug Abuse (NIDA) drug abuse studies back to the year 2000. Since then, I have participated, and managed numerous projects for multiple NIH Institutes, including:

  • National Institute on Drug Abuse (NIDA)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Pediatric Pharmacology Research Units (PPRU)
  • National Center for Complementary and Integrative Health (NCCAM)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute of Mental Health (NIMH)
  • National Cancer Institute (NCI)

I also managed and participated multiple projects/programs for U.S Food and Drug Administration (FDA), and the Department of Defense (DoD). In addition, I also serve as the RPF technical review panel and participate in the peer review of proposals(s) on behalf of NIH.

What do you think are the factors for your long-term engagement with U.S. Federal agencies?

Working with the government agencies allows us expose to the most up-to-date scientific innovations, basic science, network of SMEs, accessibility to the academic institutes. Government work serves as a stamp of approval and helps us get commercial work and allows us to stay connected to all sectors in the field and maintain our networks to experts in academia. It helps me gain experience with and trust of institutions like FDA, NIH and DoD in addition to BioPharma.

Navitas Clinical research’s Performance Assessment Report from National Institute of Health (NIH)

Evaluation Areas Rating
Quality Very Good
Schedule Exceptional
Cost Control Exceptional
Management Very Good
Regulatory Compliance Very Good

What is the expertise that you have gained working on U.S. Federal clinical trials?

For over thirty years Navitas Clinical Research (previously KAI Research) has supported the mission of nine NIH Institutes through our work as Data Coordinating Center. We specialize in providing effective support for the planning, execution and data sharing of results from multiple Intramural and Extramural research studies. This experience has been invaluable in creating our practical understanding of NIH’s mission, organization, programs, policies, business practices, management challenges, operating environment, systems, and stakeholders.

The NIH institutes in general fund numerous clinical trials to ranging in size from 100 to 19,000 participants. This exposure provides NCR a strong foothold in the NIH clinical research support space. NCR, in turn, makes significant contributions to the quality of the NIH funded clinical research and to the clinical research community in general. Quality was significantly enhanced through concept and material review, data management and analysis, and technical assistance or training. Study participant safety was improved through over numerous safety and data quality monitoring visits.

In addition to the visibility of the publically available NIH IC information resources, our position with the NIH work has allowed us to strengthen relationships with their grantees/academic centers, leading to several one-off contracts conducting safety and data quality monitoring visits as well as medical coding. Government work has allowed NCR to hone our expertise and expand our clinical research methodology in areas such as adaptive trial design, electronic health record data in research, multi-site trial operations, data management, common data elements and standards, and risk based monitoring.

What are the benefits of outsourcing clinical trials to Navitas Clinical research?

Navitas Clinical Research has the benefit of reach-back and infrastructure support from Navitas Life Sciences (NLS), combined with the advantages of a nimble health research organization that has flexibility and expertise in high-touch partnerships. We have included NLS eSolution and capabilities in several NIH RFP responses, NLS IT has been working closely with the NCR NIAMS team to support the NIAMS contract.

You recently received the NIAMS award, tell us more about it.

For the past 25 years, NCR has provided clinical research support to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The NIAMS was established in 1986 and is a part of over 27 institutes and centers which fall under the National Institutes of Health (NIH). The NIAMS supports a large portfolio of extramural grants with the aim of developing answers to critical questions regarding diseases and disease processes.

NCR’s initial role was focused on developing guidelines and clinical study material templates and providing process reviews and data audits for ongoing studies. NCR’s role has since expanded. For the past 25 years, Navitas Clinical Research, Inc. (NCR) has provided support to the NIAMS, including clinical research oversight and support, operations expertise, and clinical research guidance for NIAMS investigators. Our support includes:

  • Current contract with 25 years of support to NIAMS
  • Providing clinical research consultation, risk assessment, and recommendations to maximize performance of the research portfolio
  • Tracking all critical elements of human interventional studies
  • Maintaining Clinical Research Study Investigator's Toolbox
  • Providing support to 65+ data and safety monitoring boards to NIAMS
  • Conducting monitoring/audit visits for NIA NIAMS

Recent Landmark U.S. Federal Agency Contract

Navitas Clinical Research won a recent contract with the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) for continued support of the Institute’s research activities through 2023.

NCR is thrilled to announce the recent contract award which will allow continued support of the Institute’s research activities through 2023. NCR will continue to provide the same services to the NIAMS through this sole source contract. NCR will coordinate activities with the Contracting Officer’s Representative (COR), addressing all requirements of the 12 Task Areas as outlined in the Statement of Work.

Navitas Clinical Research’s support for U.S. Government Funded clinical trials during COVID-19

Explore 5 successful clinical studies that were conducted with Federal Government organizations, maintaining business continuity even with COVID-19 mediated disruptions.

  • Osseointegration Registry for the U.S. Department of Defense’s (DoD)
  • Clinical Consulting for the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Clinical Consulting for National Institute of Ageing (NIA)
  • Clinical Consulting for Science Applications International Corporation (SAIC)
  • Infectious Disease Study Management for the U.S Centers for Disease and Prevention (CDC)

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