Navitas Clinical Research, a part of Navitas Life Sciences Ltd, is a full-service CRO supporting diverse clients with the design, execution, and result 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 nearly three decades of experience enables us to predict needs, avoid common barriers, and move from a quick start-up through each research phase to successful execution of your project.
Setting up Registries for Foundations
Registries vary in scope, size, and in volume of participating sites, ranging from common conditions to rare diseases. The scope of the registries may also change with time, requiring the collection of additional data to support them and to keep them relevant. The potential benefits of registries require detailed planning and expertise to ensure that they are set up efficiently.
Navitas Clinical Research’s Key Steps to efficient Registry Planning and Management
- Clearly Defined Purpose
- Determination of vital stakeholders
- Assess the feasibility
- Establish a well-defined plan
- Calculate data set and identify the target population
- Develop a protocol and a project plan
- Provide training to foundation staff on registry support
- Ensure periodic critical evaluations
Developing registries for foundations requires key skills that pave the way for the development of a comprehensive registry. Here are six characteristics that define Navitas Clinical Research’s therapeutic and disease specific foundation registry effort.
1. Personalized Service: The Navitas Clinical Research team of highly skilled clinical research and registry development methodologists and SMEs, proudly provide personalized service in the areas of the central nervous system, rheumatology, musculoskeletal, pain, limb loss/preservation, oncology, and infectious diseases, in addition to many other therapeutic domains.
How Navitas Clinical research provides superlative Personalized Support
- Smart Decision making: The problems are analyzed in depth, and vast expertise and experience are used to find effective solutions.
- Unique solutions and Innovative coordination: The solutions provided are based on the unique needs and after innovative deliberations and detailed discussions
- Clear Information sharing: There is proactive communication to ensure a clear understanding of the path forward.
2. Experience working with U.S Government Agencies: Navitas Clinical Research supports multi-stakeholder studies and registries for the U.S Department of Defense (DoD), National Institutes of Health (NIH), and the clinical research programs of many therapeutic and disease specific Foundations.
Navitas Clinical research’s Performance Assessment Report from National Institute of Health (NIH)
|Regulatory Compliance||Very Good|
3. System Based Solutions: The Navitas Clinical Research team integrates independent research and client-centered consulting to create comprehensive, systems-based solutions that improve health.
Innovative Solutions for Superior Returns
- Rapid acceleration in the use of system-based solutions
- Integrated systems
- Transformation of existing traditional systems
This helps in creating powerful ecosystems that have the potential to reshape healthcare and deliver an integrated and personalized experience, while improving cost and time.
4. Digital Data Collection: The Navitas Clinical Research team understands the complexities of incorporating patient information from multiple sources while providing the tools and functionality to conduct data analysis at the population level. We have hands-on experience with electronic health record (EHR) products and work closely with interoperability standards organizations.
We put together our services and capabilities to integrate various value systems across a virtual data backbone, supported by seamless capture of health records, management as well as data utilization that can be used for enhanced experiences.
5. Scalability: We have been developing systems with scalability and sustainability to accommodate research data and patient records for the management and control of disease in large populations.
Fit for Purpose Team of Experts
Our project managers, data managers and clinical monitors all average 10 years of service in the industry
- Clinical research associates (CRAs)
- Database application designers and programmers
- Data managers
- Information technology staff
- Project managers
- Research support staff
- Statistical programmers
6. Right Infrastructure: Navitas Clinical Research provides deep infrastructure support and resources for contracting, information technology, accounting/financial management, and other administrative support, as well as reach-back for a wide array of health research technical services, as needed.
The Navitas Clinical Research team is well positioned to support the therapeutic and disease specific foundation registry programs, and will operate in a seamless fashion to bring together clinicians, patients, clinical research, clinical data management, common data element, and disease-specific knowledge with systems design, development, eSolution, EHR integration, statistical modeling and bioinformatics, regulatory support, and security methodology required to develop, implement and sustainment of important Foundation registries.
Navitas Clinical Research finds innovative ways to identify solutions to problems and drive successful outcomes. We use a variety of tools to foster an agile working system and to support smart decision making in building/supporting multiple registries.
How We Remain Preferred Clinical Partners for U.S. Federal Agencies
To understand how Navitas Clinical Research found its strategic footing and helped support numerous U.S. Federal agencies, read the exciting and insight rich interview with Dr. Yun Lu.
Dr. Yun Lu, PhD
Chief Operating Officer and VP of
Data Management & Standards, Americas
Navitas Clinical Research
(a part of Navitas Life Sciences)