Real-World Evidence:Prove Your Product's Value
Real-World Evidence Generation
Transform surgical data into compelling evidence that demonstrates your product's clinical value.
Market Differentiation
Stand out with data-driven insights that showcase your competitive advantages.
Post-Market Clinical Studies
Conduct rigorous post-market studies leveraging our extensive surgical data network.
Unlock real-world evidence.Demonstrate clinical value.Accelerate market success.
Collecting Unique Data About Your Products, to Highlight Their Value in the Real World.
Generating real world evidence doesn't mean you need a clinical trial, a registry, or even a protocol. Working directly with clinical teams, we curate financial and clinical data through an entire patient encounter, to generate a unique dataset that can quantify your product's value proposition.
Caresyntax can collect real world evidence to help with:
Regulatory Submissions
Post-market clinical follow-up (PMCF)
Publications and Scholarly Work
HEOR and value analysis
White Papers and Marketing Claims
We're here to help.
Our Differentiators
Curated Data
- No exclusion criteria
- Including financials and outcomes
Speed and Simplicity
- No IRB or consent required
- First data output within months
Regulatory Grade
- Multiple FDA Submissions and wins with RWE data
Cost Efficiency
- $1000-2000 per patient is a fraction of the price for a trial or registry
What is Caresyntax RWE?
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.
Accurate, relevant, and structured real-world clinical data: the Caresyntax RWE Process
Data Ingestion
Extracting clinical data from any source into a structured format
- Handwritten forms, unstructured data sources,
- EMR pulls
- Automatic or manual methods
Last year Caresyntax RWE collected over 13,000 patient records in support of real-world evidence projects, including:
Prospective and retrospective data
Financials
Long-term patient outcomes
Label Expansion Module
Capture data for FDA label revision or expansion
2 FDA approvals for expanded indication/updated 510(k) did not require institutional review board (IRB) approval.
2 FDA/CE post-market clinical follow-up (PMCF) requirements
Peer-reviewed abstracts, manuscripts, and book chapters
HEOR and value analysis committee (VAC) reports
White Papers
Our Proven Clinical Quality Improvement Methodology
Our 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
Read the Case Study
Learn how RWE data was used by one of our partners to update their 510(k) clearance and remove a contraindication in their labeling.
Data collected through RWE is regulatory-grade, and can be adapted to fit the needs of our customers
What Our Customers Are Saying
"Because the initiative was implemented as part of the actual patient care process to improve patient outcomes, it was deemed exempt from HIPAA rules, and the project did not require institutional review board (IRB) approval."
"Instead of taking 2-3 years...Within 6 months we were enrolling patients, and within 15 months, we were done, at a fraction of the cost and time."
"The unique thing about Caresyntax is that it connects all the dots so that we can get a clear answer. I've been in this industry for 35 years, and that's unheard of. I think this is a model for the future. We can no longer be myopic in looking at just the cost of products that are purchased. We need to evaluate the whole continuum of care."
Our Partners
Proven Results, Aligned With Your Goals
Our Caresyntax RWE 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
- Expand product indications
- Validate off-label uses and contraindications
- Gather post-market follow up data
Improve Value
- Overcome usage restrictions
- Pass VAC committee audits
- Achieve GPO and local contracts
- Demonstrate value to payors and insurers
Inform Product
- Test feasibility for new technology
- Assess design and build options
- Measure and improve use standards
FAQs
Ready to Accelerate Your Innovation?
Partner with Caresyntax to unlock the power of real-world surgical data and drive meaningful outcomes for your products.
Trusted by leading healthcare institutions and medical technology companies worldwide