5 Successful U.S Federal Government Supported Studies Continued During COVID-19 Mediated Restrictions

Navitas Clinical research, a part of Navitas Life Sciences, is a Full-Service Contract Research Organization (CRO) and health research company, which has supported multiple studies for U.S federal, academic, and pharmaceutical clients in order to bring innovative drug treatments and other interventions to market. Spanning 30+ years since its inception, Navitas Clinical Research has been at the forefront of advancement in medical research, breaking ground in supporting new drug treatments, non-invasive therapies, and medical devices.

A rigorous understanding of mechanisms that promote clinical trial operational efficiency remains at the core of our mission, with the team proud to play a key role in advancing human health.

In a year of unprecedented disruptions caused by the COVID-19 pandemic, 2020 was a poster year for innovation.

Navitas Clinical Research’s support for clinical trials during COVID-19

Navitas Clinical Research prioritized the safety of employees and patients, moving to alternate methods of working to minimize disease risk and reduce disruptions in clinical trial operations. However, innovation engines continued to function to find new steps to prevent trial disruptions, protect supply chains, and support virtual systems.

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

1) Osseointegration Registry for U.S. DoD: The U.S. Department of Defense’s (DoD) Osseointegration Program sought to bring osseointegration within the Military Health System. Navitas Clinical Research worked to ensure the continuous development, support, and maintenance of the “Osseointegration Quality Registry”. This DoD project started in February 2018, and the current contract will end in June 2021.

The project is a great example of how Navitas Clinical Research team’s deep experience in building registry platforms and managing registry programs have been effectively utilized. The team have further helped develop and implement common data elements and standards, integrate with electronic health record (HER) and EHR data, carry out clinical study operations, data management, and data analysis and visual reporting activities The team’s expertise has successfully brought the project to fruition, meeting the needs of the client.

U.S.DoD Osteointegration Program

• Artificial lntelligence (AI) change requests were fulfilled, including customization to the registry platform, modification of the data flow, and integration with EHR imaging data.
• Data Management Plan developed, with users being provided with the appropriate administrator and insight reports training.
• Long-term engagement initiated

2) Clinical Consulting for the NIAMS: The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is a Federal Government organization that supports research in to arthritis and skin diseases. Navitas Clinical Research was engaged to provide Principal Investigators assistance, which included a review of study material.

In addition, we were also required to not only assemble, but to also serve as the Executive Secretary for the NIAMS appointed Data Safety Monitoring Boards (DSMB), as well as conducting site visits and the necessary training sessions.

Clinical Consulting for NIAMS - Highlights

• 25 years of stellar clinical consultation
• Built an efficient support network for all of the NIAMS clinical study needs
• Supported 300+ DSMBs
• Supported 1000+ meetings
• Our training sessions have received very positive feedback

3) Clinical Consulting for National Institute of Ageing (NIA): NIA is focused on research into aging in the hope to improve the health of older adults. Navitas Clinical research was required to support NIA extramural investigators in two different institute divisions by providing support to their Principal Investigators with study material as well as a grant review.

We were also associated with both the assembling and the running of the Data Safety Monitoring Boards for their studies. This included preparing their reports and offering statistical support whenever needed. Implementation of site visits and training as well as resource creation for sites and investigators were also carried out.

Clinical Consulting for NIA - Highlights

• 13+ years of efficient clinical consulting support
• Built an efficient support network for all of the NIA clinical study needs in the Division of Geriatrics and Clinical Gerontology and the Division of Behavioral and Social Research.
• Supported 100+ DSMBs
• Supported 100+ investigators
• All program participants provided very positive feedback about our team’s support

4) Clinical Consulting for Science Applications International Corporation (SAIC): Science Applications International Corporation (SAIC) provides government services as well as information technology support. Navitas Clinical Research’s experienced metadata content experts lead and supported the National Institute of Health (NIH) National Cancer Institute (NCI) Common Data Elements (CDEs) and standard form development, to make them available through the cancer Data Standards Registry and Repository (caDSR) for wide distribution.

We provided support to cancer centers hosting Medidata RAVE, including working with trained curators from those sites to assist with their curation learning and to answer questions. Our support also included the development and implementation of best practices and business rules.

Clinical Consulting for SAIC – Highlights

• Demonstrated efficient clinical study capabilities together with the metadata and standardization expertise
• In December 2020, SAIC together with Navitas Clinical Research won the new 5-year contract promoting Navitas Clinical Research, Inc. to a second tier, instead of third tier sub.
• We have had significant direct exposure to the client over the past year, further strengthening our relationship.

5) Infectious Disease Study Management for CDC: The U.S Centers for Disease and Prevention (CDC) Control is the national health protection agency. It needed full service clinical support for the execution of its influenza pre- and post-vaccination sera collection study.

Navitas Clinical Research was appointed to develop the protocol and select multiple sites to conduct the study during the fall flu vaccination season. Furthermore, we were required to design a data collection system, initiate the sites, provide clinical monitoring, as well as oversee both sample collection and shipping. The CDC required reports on subject accrual as well as additional data reports.

Infectious Disease Study Management for CDC - Highlights

• Effective study support from the protocol design to final sample shipment
• Study involved pediatric, 6 months, through to geriatric populations.
• 400+ subjects enrolled within 2 months
• As an established clinical service provider, we are now celebrating our 7th year of study conduct with CDC

The major unifying and combinatorial effect of these clinical trials is the concerted breakthroughs in health, with a wealth of information gained about disease conditions and their likely treatment. A strong foundation in building efficient systems has helped in the seamless delivery of studies, maintaining business continuity even during the COVID-19 pandemic.

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