Real-world evidence infrastructure built for your product's entire lifecycle.
Celéri Health's Evidence-as-a-Service™ platform gives medtech and pharma sponsors a purpose-built, practice-embedded evidence engine — from first-in-human through post-market, from R&D through commercial launch. Structured PRO data, validated instruments, governed data operations, and a Part 11-ready EDC — deployed at your own accounts and benchmarked against a network of 350+ interventional pain and neuromodulation providers.
Built for R&D, Medical Affairs, Commercial, and Product Development teams who need real-world evidence that is structured, credible, and fit for purpose — not retrofitted from a generic registry or extracted from claims data after the fact.
The right evidence for every team in your organization.
The EaaS™ Platform serves multiple internal stakeholders at once — generating data that satisfies R&D's regulatory requirements while fueling Commercial and Medical Affairs with outcomes narratives that move the market.
R&D
Regulatory-grade RWE, post-market study design, comparative effectiveness
Medical Affairs
Publication strategy, KOL data, congress abstracts, HCP education
Commercial
Payer dossiers, market access evidence, rep and physician outcomes views
Product Development
Patient selection insights, therapy optimization data, label expansion endpoints
Regulatory-Grade Evidence Cohort™
Pre-specified protocol, IRB oversight, an EDC built to 21 CFR Part 11 requirements, and validated comparator logic — designed to support regulatory submissions, payer dossiers, and peer-reviewed publication. CRO, biostatistics, and medical writing coordinated through the Celéri Research Group as your study requires.
PainRWD™ External Control Group
Celéri Health's de-identified longitudinal dataset — condition-matched and procedure-matched — available as an external control arm or aggregate benchmarking comparator. Depending on study design and regulatory pathway, it may reduce or replace the need for a prospective control group.
Commercial Insights Registry™
Structured real-world outcomes collected prospectively from your therapy's patient population at point of care — packaged for payer access, market development, and field enablement. Turns your post-market patient population into an ongoing commercial intelligence asset.
Sponsor-Branded Patient Intelligence Platform
Your product. Your brand. Your data. Celéri Health deploys a fully branded instance of the EaaS™ Platform under your product name — a "[Product]™ Patient Intelligence Platform, powered by Celéri Health" — while Celéri Health manages infrastructure, governance, and data operations.
Publication and Congress Strategy
From abstract submission to peer-reviewed manuscript, the Celéri Research Group coordinates the publication pipeline — biostatistics and medical writing through Hart Clinical Consultants, KOL engagement and scientific communications through Feed, The Agency. Your data was structured for publication from day one of enrollment.
Therapy Optimization and Patient Selection
Structured PRO data segmented by diagnosis, baseline severity, procedure type, and responder profile gives product teams the real-world signal to refine selection criteria, optimize protocols, and identify where your product performs best.
From contract to evidence — end to end.
Celéri Health manages the full evidence program — deployment, data governance, protocol infrastructure, and delivery — so your team focuses on the science and the strategy, not the operations.
Define your evidence objective
We start with your regulatory pathway, commercial goal, or publication target. That determines which EaaS™ track fits — Commercial Insights Registry™ for observational RWE, Regulatory-Grade Evidence Cohort™ for submission-ready data — and which partner services are needed.
Deploy at your accounts
Celéri Health configures your branded platform instance and deploys it at the practices already in your commercial footprint — your therapy's implanting and prescribing accounts. Your team reviews and approves; Celéri Health executes.
Data flows automatically
Patients enroll pre-procedure and receive automated PRO assessments at every clinical milestone. Data is structured, timestamped, and delivered to your Commercial Command Center in real time — alongside EHR data pulled through Celéri Health's live integrations.
Evidence delivered
Celéri Health packages your data for the intended use — regulatory submission, payer dossier, congress abstract, peer-reviewed manuscript, or commercial insights report. Analysis, medical writing, and biostatistics coordinated through the Research Group.
Your accounts are the study. Our network makes it stronger.
Celéri Health deploys at the practices already in your commercial footprint. The broader network of 350+ interventional pain and neuromodulation providers delivers a different kind of value: context, comparison, and opportunity.
Population Benchmarking
Compare your therapy's outcomes against the broader interventional pain population — not just your own enrolled patients — with condition-matched peers across the network.
Geographic Expansion
Identify markets where your therapy is underrepresented but network practices are already active. Use coverage data to inform expansion strategy and field prioritization.
KOL Identification
Surface high-volume, outcomes-oriented practices as candidates for advisory boards, publication partnerships, or speaker programs — identified by clinical activity and data engagement, not just reputation.
Study Expansion
When an engagement needs to scale beyond current accounts — a multicenter IIT, a coverage requirement, a powered subgroup — the network provides a qualified, infrastructure-ready site pool.
One dataset. One platform. Every internal stakeholder.
Most evidence programs fragment across departments — R&D runs its own study, Medical Affairs commissions a separate publication effort, Commercial builds its own outcomes tools. They never reconcile. On the EaaS™ Platform, every function works from the same governed, prospectively collected dataset. Your regulatory submission, payer dossier, KOL briefings, and field outcomes reports all draw from a single source of truth.
Two tracks. One infrastructure.
Both tracks run on the Celéri EaaS™ Platform and its Part 11-ready EDC — scoped differently based on your regulatory requirements and commercial objectives.
Commercial Insights Registry™
Prospective outcomes collection from your therapy's real-world patient population, positioned as a commercial patient-support and outcomes program. For sponsors who need structured RWE for market access, payer conversations, field enablement, and medical affairs — without the overhead of a regulated clinical study.
- Prospective PRO collection at point of care — pre- and post-procedure
- Condition-matched benchmarking against the PainRWD™ comparator dataset
- Four-tab Commercial Command Center — 90-Day Snapshot · Signal Analysis · Rep & Physicians · Reconciliation
- Practice-level and aggregate outcomes reporting
- Payer dossier-ready outcomes summaries
- Publication and congress abstract pipeline
- Scoped per engagement — contact for a proposal
Regulatory-Grade Evidence Cohort™
Pre-specified protocol, IRB oversight, a data environment built to 21 CFR Part 11 requirements, and validated comparator logic — for sponsors whose evidence must satisfy regulators, payers with rigorous evidentiary standards, or top-tier peer-reviewed journals.
- Pre-specified protocol and statistical analysis plan
- IRB coordination and eConsent infrastructure
- Audit trail on Celéri Health's own Part 11-ready EDC
- Biostatistics, HEOR, and medical writing via the Celéri Research Group
- Supports post-market surveillance, PMA supplement, and label expansion designs
- Transition pathway from a Commercial Insights Registry™ — same patients, no rebuild
- Scoped per study design — contact for pricing
Your brand. Your patients. Celéri Health infrastructure.
Celéri Health deploys a fully branded instance of the EaaS™ Platform under your product name and visual identity. Practices see your brand in the physician Command Center and the patient-facing app. Celéri Health manages data operations, EHR integrations, PRO delivery, governance, and support — invisible to the practice, invisible to the patient.
The result: a practice-embedded commercial and evidence asset that builds outcomes data, drives therapy awareness, and deepens the practice relationship — all under your product name.
- Physician-facing Command Center with enrollment visibility
- Branded patient mobile app — myPainIntel™ white-label
- Automated PRO delivery at every clinical milestone
- EHR integration — all costs covered by Celéri Health
- Real-time enrollment and outcomes visibility for your team
- Practice-level and aggregate reporting on demand
Match your objective to the right EaaS™ track.
Every evidence objective maps to a specific capability. Use this as a starting point — most sponsor engagements span more than one row.
| Department | Objective | EaaS™ Track | Key Output | Typical Timeline |
|---|---|---|---|---|
| R&D | Generate RWE for post-market surveillance or PMA supplement | Regulatory-Grade Evidence Cohort™Regulatory | Validated outcomes dataset, CSR, submission package | 18–36 months from site activation |
| R&D | Establish a pre-specified comparator for a new therapy | PainRWD™ Science CloudExternal Control | Matched historical cohort, comparative analysis | 60–90 days from design approval |
| Medical Affairs | Submit abstracts to NANS, INS, ASPN, or ASRA | Commercial Insights Registry™Publication | Structured dataset, abstract, poster or platform presentation | 12–18 months of enrollment |
| Medical Affairs | Publish peer-reviewed real-world outcomes data | Regulatory-Grade Evidence Cohort™Publication | Peer-reviewed manuscript, journal submission | 24–36 months from protocol approval |
| Medical Affairs | Build KOL engagement and clinical data narrative | Commercial Insights Registry™KOL | Outcomes report, KOL data briefings, scientific platform | Ongoing from enrollment launch |
| Commercial | Develop a payer access dossier for reimbursement expansion | Commercial Insights Registry™Market Access | Payer-formatted outcomes summary, HEOR analysis | 18–24 months of enrollment + analysis |
| Commercial | Equip the field with real-world outcomes for HCP conversations | Commercial Insights Registry™Field Enablement | Rep & Physicians view, practice-level reports | 6–12 months of enrollment |
| Product Development | Identify optimal patient selection criteria | Commercial Insights Registry™Patient Selection | Responder profile analysis, subgroup segmentation | 12–24 months of enrollment |
| Product Development | Evaluate label expansion with outcomes in a new indication | Regulatory-Grade Evidence Cohort™Label Expansion | Pre-specified outcomes dataset, submission support | 24–36 months from protocol approval |
Already have a study design? We may already have your comparator.
The PainRWD™ Science Cloud is Celéri Health's de-identified longitudinal dataset, built from structured PRO and procedure data across the network. Condition-matched and procedure-matched cohorts are available as an external control group, which may reduce the cost and complexity of prospective comparator enrollment depending on study design. Individual-level matching is available subject to IRB or updated-consent pathways.
The partner infrastructure behind every EaaS™ engagement.
Celéri Health doesn't hand sponsors a platform and wish them luck. Every engagement is backed by specialist partners — assembled for your study, stage, and budget.
Celéri Health
Proprietary EaaS™ Platform and Part 11-ready EDC, EHR integrations, PRO delivery, de-identification, and data stewardship — operated in-house.
Hart Clinical Consultants
Site management, regulatory strategy, biostatistical design, and medical writing. Deep expertise in interventional pain and neuromodulation study design.
WCG IRB
Central IRB review and eConsent coordination for Regulatory-Grade Evidence Cohort™ engagements and IRB determinations for commercial registry programs.
Feed, The Agency
Healthcare marketing, scientific communications, and KOL narrative strategy — translating your evidence program into market impact for Medical Affairs and Commercial teams.
Socially Determined
Community-level social determinants of health enrichment for PainRWD™ Science Cloud and sponsor cohorts — context for outcomes, equity analysis, and payer conversations.
What medtech and pharma sponsors ask us most.
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No. While the network and existing data infrastructure are concentrated in interventional pain and neuromodulation, the EaaS™ Platform is therapy-agnostic. Celéri Health has supported engagements across SCS, biologics, spine hardware, and regenerative medicine, and the PRO library applies to any therapy delivered in a pain management or spine context. Sponsors in adjacent and emerging therapy areas are also in active conversation with Celéri Health.
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Engagements are scoped to the evidence objective, number of accounts, enrollment target, follow-up duration, and instrument battery. A Commercial Insights Registry™ typically includes platform configuration, account onboarding, PRO infrastructure, EHR integration, and the Commercial Command Center; Regulatory-Grade Evidence Cohort™ engagements add protocol, IRB, and CRO components. Pricing is fixed at award so budgets don't drift. Contact us for a proposal.
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Commercial Insights Registry™ programs are positioned at inception as commercial patient-support and outcomes programs, with consent scope and data-use terms structured so the evidence can later support regulatory-grade purposes through an IRB determination or waiver pathway if needed. Regulatory-Grade Evidence Cohort™ engagements deploy full IRB oversight and eConsent from the start, typically through WCG IRB. Celéri Health's posture is advisory — we help sponsors structure consent frameworks that are both operationally practical and defensible.
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In many cases, yes. The PainRWD™ Science Cloud is available for condition-matched and procedure-matched comparator analysis, with ZIP-level SDOH enrichment through Celéri Health's Socially Determined partnership. Individual-level matching requires IRB coordination or updated consent depending on the design. In some observational designs, PainRWD™ may reduce or replace the need for a prospective control group.
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Data governance is defined by the engagement agreement. In all cases, Celéri Health handles PHI stripping, normalization, Safe Harbor de-identification, and data stewardship. Sponsors receive rights to data generated under their engagement as specified in the contract. Practices contribute data under Celéri Health's data-use framework and are compensated at fair market value. Celéri Health retains the right to use de-identified, aggregated data for network benchmarking and the PainRWD™ Science Cloud — practices are never in a direct data-licensing relationship with sponsors.
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A Commercial Insights Registry™ can be operational in about 8 weeks, with first patient enrollment typically within 60–90 days of contract execution — faster where accounts are already running PainIntel™. Regulatory-Grade Evidence Cohort™ engagements need additional lead time for protocol finalization, IRB approval, and EDC configuration — typically 4–6 months to first enrollment.
Tell us what evidence you need to generate.
Whether you're designing a post-market study, building a payer access dossier, or launching a new therapy into a competitive market — Celéri Health will map your objective to the right EaaS™ track and stand up the infrastructure to get there.
