Medtech & Pharma — Celéri Health
Who We Serve — Medtech & Pharma

Real-world evidence infrastructure
built for your product's entire lifecycle.

Celéri'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, IRB oversight, and a practice network of 350+ interventional pain and neuromodulation providers, all coordinated through a single evidence infrastructure partner.

350+
Interventional pain & neuromodulation providers — benchmarking, expansion & KOL network
30+
Validated PRO instruments — automatically collected at point of care
RWD
De-identified longitudinal comparator dataset — PainRWD™ Science Cloud
2
Evidence tracks — Commercial Insights Registry™ & Regulatory-Grade Evidence Cohort™

Built for R&D, Medical Affairs, Commercial, and Product Development teams at medtech and pharma companies 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.

Celéri's EaaS™ platform is designed to serve multiple internal stakeholders simultaneously — generating data that satisfies your R&D team's regulatory requirements while also fueling Commercial and Medical Affairs with outcomes narratives that move the market.

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R&D

Regulatory-grade RWE, IDE & post-market study design, comparative effectiveness

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Medical Affairs

Publication strategy, KOL data, congress abstracts, HCP education tools

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Commercial

Payer dossiers, market access evidence, sales force outcomes tools, rep dashboards

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Product Development

Patient selection insights, therapy optimization data, label expansion endpoints

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R&D

Regulatory-Grade Evidence Cohort™

Pre-specified protocol, IRB oversight, 21 CFR Part 11 audit trail, and validated comparator logic — designed to support FDA submissions, payer dossiers, and peer-reviewed publication. Greenlight Guru Clinical EDC and Hart Clinical Consultants CRO infrastructure included through the Celéri Research Group.

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R&D

PainRWD™ External Control Group

Celéri's de-identified longitudinal patient database — condition-matched and procedure-matched — available as an external control arm or aggregate benchmarking comparator. Eliminates the need for a prospective control group in many study designs, reducing cost and timeline.

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Commercial

Commercial Insights Registry™

Structured real-world outcomes data — collected prospectively from your therapy's patient population at point of care — packaged for payer access submissions, market development, and sales force enablement. Turns your post-market patient population into an ongoing commercial intelligence asset.

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Commercial · Medical Affairs

Sponsor-Branded Patient Intelligence Platform

Your product. Your brand. Your data. Celéri deploys a fully branded instance of the EaaS™ platform under your product name — "[Product]™ Patient Intelligence Platform, powered by Celéri" — giving practices a white-labeled experience while Celéri manages the underlying infrastructure, governance, and data operations.

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Medical Affairs

Publication & Congress Strategy

From abstract submission to peer-reviewed manuscript, Celéri's Research Group coordinates the full publication pipeline — biostatistics, medical writing, and KOL engagement through Hart Clinical Consultants and Feed, The Agency. Your data was structured for publication from day one of enrollment.

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Product Development

Therapy Optimization & Patient Selection

Structured PRO data across your patient population — segmented by diagnosis, baseline severity, procedure type, and responder profile — gives product teams the real-world signal to refine patient selection criteria, optimize therapy protocols, and identify the populations where your product performs best.

From contract to evidence — end to end.

Celéri manages the full evidence program — site network, data governance, protocol infrastructure, and delivery — so your team focuses on the science and the strategy, not the operations.

01

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.

02

Deploy at Your Accounts

Celéri configures your branded platform instance and deploys it at the practices already in your commercial footprint — your therapy's implanting and prescribing accounts. Protocol infrastructure, IRB, EDC, and data governance are activated through the Celéri Research Group. Your team reviews and approves; Celéri executes.

03

Data Flows Automatically

Patients enroll pre-procedure and receive automated PRO assessments at every clinical milestone. Data is structured, timestamped, and delivered to your Evidence & Enrollment Dashboard in real time — alongside EHR data pulled through Celéri's eight live integrations.

04

Evidence Delivered

Celéri 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 dataset, ready to move.

Your accounts are the study.
Our network makes it stronger.

Celéri deploys at the practices already in your commercial footprint — your therapy's accounts. The broader Celéri network of 350+ interventional pain and neuromodulation providers delivers a different kind of value: context, comparison, and opportunity.

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Population Benchmarking

Compare your therapy's outcomes against the broader interventional pain population — not just your own enrolled patients. Understand how your real-world results sit relative to condition-matched peers across the Celéri network.

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Geographic Expansion

Identify markets where your therapy is underrepresented but Celéri-connected practices are already active. Use network coverage data to inform commercial expansion strategy and field force prioritization.

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KOL Identification

Surface high-volume, outcomes-oriented practices across the network as candidates for advisory boards, publication partnerships, or speaker programs — identified by actual clinical activity and data engagement, not just reputation.

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Study Expansion

When a sponsor engagement needs to scale beyond current accounts — for a multicenter IIT, a geographic coverage requirement, or a powered subgroup analysis — the Celéri network provides a qualified, infrastructure-ready site pool without starting from scratch.

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One dataset. One platform. Every internal stakeholder.

Most evidence programs fragment across departments — R&D runs their own study, Medical Affairs commissions a separate publication effort, Commercial builds its own outcomes tools. They never reconcile. Celéri changes that. Every function — R&D, Medical Affairs, Commercial, Product Development — works from the same governed, prospectively collected dataset on the same platform. Your regulatory submission, your payer dossier, your KOL data briefings, and your sales force outcomes reports all draw from a single source of truth. No reconciliation. No conflicting numbers. One program that serves the whole organization.

Two tracks. One infrastructure.

Both tracks run on the same PainIntel point-of-care platform and practice network — scoped differently based on your regulatory requirements and commercial objectives.

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Commercial Insights Registry™

Observational, prospective data collection from your therapy's real-world patient population. Designed for sponsors who need structured RWE for market access, payer conversations, field force enablement, and medical affairs — without the overhead of a regulated clinical trial.

  • Prospective PRO collection at point of care — pre- and post-procedure
  • Condition-matched benchmarking against PainRWD™ comparator dataset
  • Practice-level and aggregate outcomes reporting
  • Sponsor Evidence & Enrollment Dashboard — real-time site visibility
  • Payer dossier-ready outcomes summaries
  • Publication and congress abstract pipeline
  • Baseline engagement: $150K/year
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Regulatory-Grade Evidence Cohort™

Pre-specified protocol, IRB oversight, 21 CFR Part 11-compatible data environment, and validated comparator logic — for sponsors whose evidence needs to satisfy FDA, payers with rigorous evidentiary standards, or top-tier peer-reviewed journals.

  • Pre-specified protocol and statistical analysis plan
  • IRB coordination and eConsent infrastructure
  • 21 CFR Part 11 audit trail via Greenlight Guru Clinical
  • Biostatistics and HEOR analysis — Hart Clinical Consultants
  • Supports post-market surveillance, PMA supplement, and PCORI-style RWE
  • Medical writing and regulatory document support
  • Scoped per study design — contact for pricing
Sponsor-Branded Platform

Your brand.
Your patients.
Celéri infrastructure.

Celéri deploys a fully branded instance of the EaaS™ platform under your product name and visual identity. Practices see your brand in the physician dashboard and patient-facing app. Celéri manages the 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.

Example Branded Instance
[Your Product]™ Patient Intelligence Platform
powered by Celéri Health
  • Physician-facing Evidence & Enrollment Dashboard
  • Branded patient mobile app — myPainIntel™ white-label
  • Automated PRO delivery at every clinical milestone
  • EHR integration — 8 systems, all costs covered by Celéri
  • Real-time enrollment and outcomes visibility for your team
  • Practice-level and aggregate reporting on demand
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Already have a study design? We may already have your comparator.

The PainRWD™ Science Cloud is Celéri's de-identified longitudinal patient database — built from structured PRO and procedure data collected across the Celéri practice network. Condition-matched and procedure-matched cohorts are available as an external control group, reducing the cost and complexity of prospective comparator enrollment in many study designs. Individual-level matching available subject to IRB or updated consent protocols.

Match your objective to the right EaaS™ track.

Every evidence objective maps to a specific Celéri 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, regulatory submission package 18–36 months from site activation
R&D Establish a pre-specified comparator for a new therapy PainRWD™ Science Cloud External Control Matched historical cohort, comparative analysis 60–90 days from study design approval
Medical Affairs Submit abstracts to NANS, ISMCS, 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 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 field force with real-world outcomes for HCP conversations Commercial Insights Registry™ Sales Enablement Practice-level outcomes dashboard, rep-facing reports 6–12 months of enrollment
Product Development Identify optimal patient selection criteria for a therapy 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, regulatory submission support 24–36 months from protocol approval

The partner infrastructure behind every EaaS™ engagement.

Celéri doesn't hand sponsors a platform and wish them luck. Every EaaS™ engagement is backed by best-in-class specialist partners — assembled for your specific study, stage, and budget.

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EDC & QMS
Greenlight Guru Clinical
Purpose-built EDC and quality management for regulated medical device studies. 21 CFR Part 11-validated. The interim infrastructure for Celéri's regulatory-grade engagements ahead of full proprietary Part 11 readiness.
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CRO · Regulatory · Biostatistics
Hart Clinical Consultants
Site management, regulatory strategy, biostatistical design, behavioral science, and medical writing. Deep expertise in interventional pain and neuromodulation study design.
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Communications · Reputation
Feed, The Agency
Healthcare marketing, scientific communications, and KOL narrative strategy — translating your evidence program into market impact for Medical Affairs and Commercial teams.

What medtech and pharma sponsors ask us most.

  • No. While Celéri's practice network and existing data infrastructure are concentrated in interventional pain and neuromodulation, the EaaS™ platform is therapy-agnostic. We have supported engagements across SCS, biologics, spine hardware, and regenerative medicine — and our PRO library and data infrastructure are applicable across any therapy delivered in a pain management or spine context. Sponsors in adjacent therapy areas — including behavioral health and psychedelic-assisted therapy — are also in active conversation with Celéri.
  • The Commercial Insights Registry™ baseline engagement starts at $150,000/year, which includes platform configuration, site onboarding, PRO infrastructure, EHR integration, and the Evidence & Enrollment Dashboard. Additional fees apply for network expansion, per-patient data contribution, and platform license components depending on study scope. Regulatory-Grade Evidence Cohort™ engagements are scoped per study design — contact the Celéri evidence team for a custom proposal.
  • For Commercial Insights Registry™ engagements, Celéri works with sponsors to structure broad-consent data use frameworks that are defensible under 45 CFR 46.116(d), allowing for secondary use of prospectively collected data without requiring study-specific consent at each site. For Regulatory-Grade Evidence Cohort™ engagements, full IRB oversight and eConsent infrastructure are deployed — typically through WCG IRB with Hart Clinical Consultants coordinating site-level compliance. Celéri's posture is advisory and collaborative — we help sponsors structure consent frameworks that are both operationally practical and scientifically defensible.
  • Yes, in many cases. The PainRWD™ Science Cloud is Celéri's de-identified longitudinal patient database, available for condition-matched and procedure-matched comparator analysis. ZIP-level SDOH enrichment is immediately available through Celéri's Socially Determined partnership. Individual-level matching requires IRB coordination or updated consent, depending on the study design. In many observational study designs, PainRWD™ eliminates the need for a prospective control group entirely — reducing cost and enrollment timeline significantly.
  • Data governance is defined by the engagement agreement. In all cases, Celéri handles PHI stripping, normalization, Safe Harbor de-identification, and data stewardship. Sponsors receive rights to the data generated under their engagement, as specified in the contract. Practices contribute data under Celéri's data use framework and are compensated at fair market value. Celéri retains the right to use de-identified, aggregated data for network benchmarking and the PainRWD™ Science Cloud — practices never sell data directly and are never in a direct data licensing relationship with sponsors.
  • For a Commercial Insights Registry™ engagement with existing Celéri network sites, first patient enrollment typically begins within 60–90 days of contract execution — faster if sites in the sponsor's preferred geography are already running PainIntel. Regulatory-Grade Evidence Cohort™ engagements require additional lead time for protocol finalization, IRB approval, and EDC configuration — typically 4–6 months to first enrollment. Celéri's practice network dramatically reduces site startup time compared to a traditional CRO engagement building a site network from scratch.

Tell us what evidence you need to generate.

Whether you're designing a post-market surveillance study, building a payer access dossier, or launching a new therapy into a competitive market — Celéri's evidence team will map your objective to the right EaaS™ track and stand up the infrastructure to get there.