Quality evidence by design™
Established by the U.S. Food & Drug Administration (FDA), NESTcc is an independent coordinating center driving quality and efficiency in the use of real-world data (RWD) to inform medical device development and evaluation.
We support clinical, patient, regulatory, and reimbursement decisions throughout the total product life cycle (TPLC), delivering quality evidence by design.
Why is NESTcc a research partner that is different?
Comprehensive research experience based on quality data and trustworthy outcomes.
NESTcc has developed real-world evidence (RWE) studies across 10 disease areas, all device classes, and all stages of the TPLC.
Our Research Network
To deliver reliable RWE from a total population of 161 million patients, we curate partnerships with leading research institutions.
Aligned with the needs of stakeholders across the medical device ecosystem
NESTcc’s vision is to be the the leading organization within the medical device ecosystem for conducting trustworthy, high-quality, and efficient RWD research throughout the TPLC.
Our independence, superior data access coupled with clinical and analytical expertise from world-class research institutions, and oversight by FDA on our methods and data quality, mean we convert your research investment dollars into progress for your organization.
Click on the stakeholders to explore how we can help advance your goals with RWE.
Delivering studies designed for device evaluation throughout the total product life cycle
A consultative approach that brings quality and efficiency to evidence
We guide the design and execution of studies to deliver results that are fit for purpose. Our team works across our Research Network to assess databases and identify the partners best positioned to answer the question of interest. With a deep understanding of evidentiary requirements and a rigorous approach to data quality and methodologies, we provide expertise in project and data management to drive a successful study from initiation through completion.
Introduce research sponsor to NESTcc capabilities
Deliver outline of study details to NESTcc Research Network
Form research team of premier Network Collaborators
Submit study proposal to research sponsor
Plan stakeholder engagement
Introduce sponsor to relevant regulators (if applicable)
Develop draft protocol
Develop data management plan
Review data quality and methods for study
IRB approval of protocol
Conduct project and risk management
Perform preliminary analysis
Deliver preliminary results data quality review
Collect final data from study
Collect final results
Perform final results data quality review
Carry out 360° evaluation and retrospective
Complete project closure activities and sign-off