CARESYNTAX CLINICAL DATA AS A SERVICE
Collecting unique data about your products, to highlight value in the real world.
Our Medtech partners face unique challenges introducing innovative healthcare products. In a complex, evolving market with diverse patients, clinical users, and provider systems, data can become overwhelming and create more noise than signal.
We're here to help.
Our Differentiators
Curated Data
Including financials & outcomes
Fewer Processes
Data without IRB or HIPAA approvals
Rapid Results
First report output in months
Lower Cost
Fraction of the price of traditional RCTs and registries
What is Clinical Data as a Service?
Caresyntax works directly with clinical teams to collect data to prove the clinical and economic value of your products as they are used. Then, we use feedback loops to identify the true measures that impact value and outcomes for patients.
Watch to learn from our CMIO about our CDaaS offering
Caresyntax Clinical Data as a Service: end to end data collection, data science, and reporting
Our proven Clinical Quality Improvement methodology
Our patent-pending methodology integrates the clinical team into the process to ensure data reflects site-specific context. Then with an iterative cycle of Clinical Quality Improvement, we can adjust data collection to suit the needs of all parties.
Simple Data Visualization
We summarize all data projects into easy-to-use data visualization and reports
Watch to see how our custom data visualization dashboards can highlight the value of any product or service in the continuum of care.
Our Successes
We have helped large strategics and new startups by applying our data ingestion platform, data curation services, and visualization methods to help them assess the true value of their products in the real world.
Watch to learn how our quality improvement methodology has already helped our clients
Case Study
Our data science and visualization methods can prove value for any product, drug, or process in the course of patient treatment.
Watch to learn how our data helped a pharma partner prove its economic value, despite a higher upfront cost
Our Partners
Our Hospital Partners
Proven Results, Aligned With Your Goals
Our Clinical Data as a Service drives value across the product adoption cycle: portfolio planning, go to market planning, uptake and adoption, expansion, value improvement, and most importantly, product performance and improvement potential.
Grow
Revenue
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Expand product indications
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Validate off-label uses and contraindications
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Gather post-market follow up data
Improve
Value
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Overcome usage restrictions
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Pass VAC committee audits
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Achieve GPO and local contracts
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Demonstrate value to payors and insurers
Inform
Product
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Test feasibility for new technology
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Assess design and build options
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Measure and improve use standards
Resources
Now Live!
Dr. Ramshaw sits down with different players in the healthcare system (physicians, entrepreneurs, thought leaders, medtech leaders, policymakers) to discuss how data is used today, and what it COULD do if it were used effectively: how it could improve surgical quality, education, outcomes, and drive better patient care.
Data Nerds in the OR: A Surgeon’s Journey Toward Value-Based Care is a limited series podcast focused on data and data science as the keys to a better healthcare system- ideas brought to life by the vision and experience of host Dr. Bruce Ramshaw.
If you’re interested in the intersection of surgery, data science, healthcare policy, and improving overall quality of care, this is the show for you!
Caresyntax Platform Modules
Unlock further value and unique data with add-ons from our Data-Driven Surgery Tech Platform.
Caresyntax offers a full stack of tech and services modules to extract curated longitudinal data from the point of care, and a proven data science methodology to distill information into understandable visual outputs. Then, with our iterative Clinical Quality Improvement process, we return value to end users, providing actionable insights for clinical quality improvement in the OR
FAQs
- Clinical Data as a Service (CDaaS) is Caresyntax’s suite of tech and professional services to collect and analyze real world evidence (RWE) generated in the normal course of treatment throughout a surgical patient process.
- CDaaS follows a Clinical Quality Improvement (CQI) methodology to gather data and provide analyses to drive value–based quality improvement initiatives.
- RWE captured in these projects can be collected without requiring Institutional Review Board (IRB) submission or individual patient consent (as discussed in more detail below). Clinical Quality Improvement initiatives do not meet the criteria for research on human subjects according to the US Department of Health and Human Services.
- Industry partners can use CDaaS to analyze de-identified RWE and RWD about the use of their product(s) in operating rooms in the US, Europe, and beyond. Caresyntax acts as a data analytics engine for both clinical and industry partners, and takes on the burden of data collection, cleansing, analysis, and reporting. The outputs of a CDaaS project are discussed in more detail below, but can be any form of data analytics, reports, white papers, presentations, publications, regulatory submissions, etc., based on partner needs.
- The CDaaS CQI method is FDA-validated when conducted as part of a CQI initiative in partnership with clinical teams and healthcare providers.
- A CDaaS project can capture and analyze any data generated throughout the entire surgical patient journey. This could include data points from the pre– and post-operative settings, along with any data used or generated during surgery.
- In terms of data modalities, a CDaaS project could include clinical data from:
- Electronic medical records (EMRs)
- Imaging data (including diagnostic imaging and scans)
- Video (including endoscopic and in-room cameras)
- Medical device data
- Direct patient follow-up including long-term outcomes information (PREMs. PROMs, patient-facing portals and apps)
- Hospital financial data
- This is a non-exhaustive list of data modalities – datasets are customized to fit the needs of each project
- The specific data points to be collected are determined in the initial CDaaS workshops, aligning around the needs of the industry partner and capabilities of the participating clinical sites.
- The data collection process is not limited to a prescribed protocol – it is continuously adapted throughout the project, giving the industry and clinical teams the opportunity to adjust their datasets and methodologies in response to new learnings and CQI initiatives.
- CDaaS projects produce two categories of outputs: CQI deliverables to the clinical teams, and de–identified commercial analyses and reports to any involved industry partners
- For clinicians/providers: CQI deliverables are a series of impartial, value-based assessments reporting on the entire patient process for a specified surgical procedure. Data is collected and analyzed in three–month cycles referred to as “CQI cycles”. A deliverable is generated at the conclusion of each CQI cycle, and usually includes a combination of pre-, peri-, and post-operative data, EMR/EHR information, outcomes, PREMs/PROMs, financial, and efficiency analyses, depending on the specifics of the project. The deliverables are shared with the surgical care team and other relevant stakeholders in the form of reports and sophisticated data visualization dashboards.
- For industry partners: de–identified commercial analyses are customized to the needs of a specific project. They are generally designed to improve patient outcomes and to document the value story of the product being evaluated in the CQI project. CDaaS methodology is uniquely able to identify the optimal subpopulations and techniques which maximize the value of a given product. Previous CDaaS outputs have taken the form of sales collateral, abstracts, and manuscripts, and CDaaS data has been utilized in submissions which resulted in multiple successful FDA awards.
How is CDaaS different from other data collection and aggregation offerings available on the market?
- Based on our expertise with clinical data ingestion, curation, data science, and quality improvement for value–based care, many clinical teams engage with Caresyntax to perform CQI projects directly on their behalf.
- For projects with an industry sponsor, Caresyntax engages with clinical partners (including those suggested by the sponsor’s team) to identify surgeons whose practice best meets the criteria of the proposed project. Caresyntax contracts with those clinical teams (and their related stakeholders as necessary) to allow sharing of data and to provide them with impartial CQI deliverables regarding the procedure in question.
- The methodology has been reviewed and approved by an independent ethics board, and the FDA has repeatedly awarded product indications and labeling based on data collected through CDaaS projects. To date, Caresyntax partners have included CDaaS data as part of multiple FDA submissions and numerous peer-reviewed journals and conferences.
- Based on our expertise with clinical data ingestion, curation, data science, and quality improvement for value-based care, many clinical sites engage with Caresyntax to perform CQI projects directly on their behalf.
- For projects with an industry sponsor, Caresyntax engages with clinical sites (including those suggested by the sponsor’s team) to identify surgeons whose practice best meets the criteria of the proposed project. Caresyntax contracts with those clinical teams
- As the intermediary party between clinical sites and industry partners, the raw clinical data always belongs to the clinical site where it was collected. Caresyntax, through the data collection and curation process, creates a set of de-identified data records for analysis and report creation, which are then shared with the industry partners.
- Yes – CDaaS data has already been included in numerous peer-reviewed publications. Due to the speed of our process, we can work with partners to scope a project with very specific timelines – for instance, many of our partners will launch a CDaaS project with a plan to have data available for submission to upcoming conferences.
- Caresyntax has partner sites in both the US and the EU that can be included for a clinical data project. However, CDaaS projects are not limited to current Caresyntax sites – we can deploy our data collection system and methodology anywhere the partner’s product (device, drug, technology, or service) is in use today.
- We have extensive experience with GDPR and HIPAA regulations, and we work with our partners on a per-project basis to understand the regulatory requirements of the project, and to ensure that all data processing and storage is handled in compliance with all applicable regulations.
- Not necessarily. In most cases, a CDaaS project does not require IRB review or approval because the project does not meet the criteria for research on human subjects as outlined by the HHS/FDA. Because of our partnership directly with the surgical teams in a healthcare operations role for quality improvement, we can provide de–identified analyses to industry partners rapidly.
- The methodology for CDaaS has been reviewed and approved by an independent ethics board. If, for a specific project, oversight by an IRB or other Ethics Board is preferred by the industry partner or one of the participating clinical sites, Caresyntax can facilitate the deployment of a CDaaS project with central and/or local IRBs (often under an IRB-approved waiver of consent).
- CDaaS projects are much faster than traditional clinical trials for three key reasons:
- CDaaS projects capture RWE generated in the standard of care setting and don’t rely on data entry into an electronic data capture system (EDC)
- CDaaS projects generally don’t require IRB or Ethics Board review (and if they do require IRB review, it is generally under a waiver of consent)
- CDaaS projects can drive results with relatively small datasets: most of our projects only require several dozen to a few hundred patients to identify meaningful levers of value and potential quality improvement opportunities.
- These factors allow us to scope a project, collect, cleanse, and analyze data, and deliver actionable insights in months instead of the years required for a traditional clinical trial.
CDaaS for Medtech