Who does the Research chapter support?
The Research chapter supports companies at any stage in the program to evaluate their technology in the healthcare setting, from product discovery to clinical trials. We will guide you through the research process, and support the collection of real-world data from patients, clinicians, and other hospital stakeholders to drive evidence-based development of your technology.
How is the program structured?
The Research chapter works with companies and their invention, commercialization or adoption team advisor to develop and execute a research project from pre-study preparation to post-study dissemination. The required services can be tailored to the scope of the project and needs of the company.
Pre-Study Services
Pre-study services encompass all aspects of research readiness to ensure that the project is set up for success. Services offered in this phase will result in a study protocol ready for submission to institutional ethics review boards or regulatory bodies, and will include:
- study preparation, including project roadmap development, clinical champion and study team identification, and outcomes determination,
- document preparation, including a standard research protocol, informed consent and assent materials, recruitment materials, case report form development, and trial master file preparation, and
- study commencement services, including team training, site initiation preparation, and database development.
Cost: The cost for pre-study support typically ranges from $30,000 – $50,000 depending on the needs of the project and your company.
Study Conduct Services
The Research chapter offers more high-touch support for the conduct of a research study from initiation to close-out. Services offered in this phase align with typical study coordinator delegations, including:
- direct communication and data collection with participants, including obtaining informed consent,
- communication with institutional department, including ethics review boards, quality assurance teams, and statisticians,
- trial master file management and document control,
- compliance preparation, including data validation or “second checking”, and database cleaning, and
- study close-out services.
Cost: The base cost for study conduct services that include preparation, initiation and close out services typically ranges from $45,000 to $60,000. Factors such as large sample sizes, complex study designs, and/or tight timelines may increase this base cost.
Post-Study Services
Post-study dissemination services offer final scientific and technical report writing to summarize findings and future directions from the research. Publications may also take the form of journal manuscripts, white papers, and lay articles depending on the needs of the company.
Cost: The cost for post-study services typically ranges from $3,000 to $7,000.