What Qualitee 360 does

Qualitee 360, LLC is a privately held Atlanta-based healthcare data analytics and consulting firm operating as a federally registered Patient Safety Organization (PSO) under the Patient Safety and Quality Improvement Act of 2005. The company serves two primary customer segments: clinical providers (hospitals, surgery centers, healthcare systems, and specialty registries) and medical device/pharmaceutical manufacturers. It delivers services including data abstraction, comparative and statistical analysis, product value analysis consulting, long-term patient follow-up, sponsored research collaboratives, FDA submission support, specialty registries, quality and safety improvement initiatives, and clinical peer-reviewed publication development. The company emphasizes real-world evidence generation and longitudinal patient outcome monitoring, with notable concentration in bariatric, spine, and endoscopy surgical specialties.

The firm's underlying technology stack combines a HIPAA-compliant healthcare data analytics platform with a Patient Safety Evaluation System (PSES) framework that provides privilege and confidentiality protections for Patient Safety Work Product (PSWP). It implements secure web, file transfer, and email transmission infrastructure with "least-needed data" principles that strip PII, PHI, and HIPAA identifiers from systems unless specifically required for analysis. Two in-house software engineers (Lee Autore as Solutions Engineer and Chris Spencer as Full Stack Developer) support SaaS application development, cloud architecture, and cyber-security for data integrity. Multidisciplinary clinical expertise is provided by team members including a Lead Biostatistician with 70+ peer-reviewed publications (Dr. Eric Heidel) and a Managing Director of Medical Affairs with 65+ HEOR publications (Dr. Minal Jain).

The business model is predominantly professional services and managed services, with revenue generated from custom consulting engagements priced on a quote basis with multi-year contract cadences. The go-to-market motion is enterprise field sales and direct sales-led, reaching customers through corporate website lead capture, phone/email outreach, ASMBS Corporate Council membership-driven referrals, and earned media via peer-reviewed publications. Customer segments are vertically segmented between clinical providers (segment type: use case) and medical device/pharmaceutical manufacturers (segment type: use case). No publicly disclosed pricing tiers, revenue figures, or external institutional investment exist in available source material.

Name

Qualitee 360

Legal name

Qualitee 360, LLC

Website

https://qualitee360.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Qualitee 360 is an Atlanta-based healthcare data analytics and consulting firm that operates as a federally registered Patient Safety Organization, delivering real-world evidence, quality improvement, and FDA submission support to hospitals, surgery centers, and medical device manufacturers.

Ownership category

akta.pro rank

Product category

Healthcare Data Analytics & Informatics Consulting

NAICS

Computer Systems Design and Related Services (54151)

SIC

Services-Computer Processing & Data Preparation (7374)

akta.pro primary industry

eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB)

Keywords

• Healthcare data analytics
• Patient safety organization
• Clinical data abstraction
• Quality improvement consulting
• Medical device research

Headquarters

HQ city

Atlanta

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Data Abstraction & Analysis Services: Meticulous data collection and analysis services for healthcare providers and medical device manufacturers. Includes extracting relevant information from medical records, clinical trials, and patient records to support research and regulatory compliance.
2. Quality Improvement & Safety Programs: Quality improvement projects and safety initiative programs for healthcare organizations. These collaborative engagements aim to enhance patient care before and after surgery, identify gaps in care, and improve return on investment.
3. Sponsored Collaboratives & Research Programs: Facilitated partnerships between medical device companies and healthcare providers for joint research. Includes FDA submissions, clinical peer-reviewed publications, white papers, and value analysis committee materials.
4. Product Value Analysis Consulting: In-depth analysis of product value propositions including cost-effectiveness, clinical benefits, and market positioning to inform strategic decision-making and market penetration strategies.
5. Long-Term Patient Follow-Up Services: Monitoring patient outcomes post-procedure, providing manufacturers with valuable data on product performance, durability, and patient satisfaction over extended periods.
6. Sales Training Programs: Customized sales training programs based on analyzed data for medical device sales teams, tailored to communicate product value and drive sales success.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Qualitee 360 is a healthcare data analytics and informatics consulting firm that operates as a federally recognized Patient Safety Organization (PSO). The company delivers data abstraction, comparative and statistical analysis, quality and safety improvement programs, real-world evidence generation, long-term patient follow-up, FDA submission support, and clinical publication services to hospitals, surgery centers, medical device manufacturers, and pharmaceutical companies.

Product overview

Qualitee 360 is a healthcare data analytics and informatics consulting firm that functions as a Patient Safety Organization (PSO). Rather than a single unified software product, the company offers a portfolio of specialized consulting and analytical services including Data Abstraction & Entry, Product Value Analysis Consulting, Product Outcomes Monitoring, Long-Term Patient Follow-Up, Comparative & Statistical Analysis, Quality & Safety Improvement Initiatives, Sales Training Based on Analyzed Data, Surgeon Collaborative, Specialty Registries, FDA Reports & Submissions, Sponsored Collaboratives, Research Programs, and Clinical Peer-Reviewed Publications. These services work together to help hospitals, surgery centers, healthcare professionals, medical device manufacturers, and pharmaceutical companies improve patient safety, quality, and outcomes through real-world evidence and data excellence.

Differentiator

Problem solved

Functional benefit

Products and services

• Data Abstraction & Entry
• Product Value Analysis Consulting
• Product Outcomes Monitoring
• Long-Term Patient Follow-Up
• Comparative & Statistical Analysis
• Quality & Safety Improvement Initiatives
• Sales Training Based on Analyzed Data
• Surgeon Collaborative
• Specialty Registries
• FDA Reports & Submissions
• Sponsored Collaboratives
• Research Programs
• Clinical Peer-Reviewed Publications

Quantifiable outcome

• Data-driven insights to minimize complications and make informed care decisions
• +1 more outcomes

Named customers21 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• ASMBS Corporate CouncilcoreStrategic or Co-development PartnerQualitee 360 is a proud partner and member of the ASMBS (American Society for Metabolic and Bariatric Surgery) Corporate Council. The partnership focuses on enhancing and developing joint strategies and efforts of bariatric surgeons, healthcare, and industry professionals in addressing challenges of obesity through a proactive approach.

Scale indicators3 records

Recent moves3 records

Expansion highlights4 records

Broad incumbents

• IQVIA: Global CRO and healthcare data analytics leader offering real-world evidence, technology platforms, and clinical operations to pharma and medtech. Broad overlap with Qualitee 360's FDA submission, RWE, and provider-facing data abstraction services.
• ICON plc: Global CRO with sizable real-world evidence, post-market, and clinical analytics practices serving medical device and biopharma sponsors. Comparable to Qualitee 360 in targeting medtech clients with evidence-generation and regulatory deliverables.
• Clario: Clinical trial endpoint technology and data analytics platform spanning eCOA, imaging, and respiratory/cardiology endpoints, supporting FDA submissions. Overlaps with Qualitee 360 on FDA-grade clinical data capture and analytics for medtech sponsors.
• TriNetX: Real-world evidence network used by hospitals, sponsors, and CROs to run federated queries on de-identified patient data for feasibility, observational research, and FDA-grade submissions. Compares to Qualitee 360's specialty-registry and RWE work for medtech clients.
• Medidata Solutions (Dassault Systèmes): Enterprise clinical trial technology platform offering EDC, eCOA, and real-world evidence infrastructure to biopharma and medtech sponsors. Overlaps with Qualitee 360 on clinical data capture, FDA-submission support, and analytics delivered to medical device manufacturers.

Direct peers

• Advarra: Provider of clinical research services including IRB review, biosafety, and clinical technology to sponsors and sites. Comparable to Qualitee 360 as a services-led firm sitting between providers and medtech/biopharma sponsors across the research lifecycle.
• Surgical Momentum: Predecessor firm founded and led by Qualitee 360's CEO Kevin D. Jackson. Surgical Momentum was a quality-improvement consulting firm serving hospitals and medical device companies in the same niche, providing a direct template for Qualitee 360's current offerings.

Emerging players

• Flatiron Health: Oncology-focused real-world evidence company acquired by Roche, providing curated clinical datasets and point-of-care research infrastructure to providers and sponsors. Comparable to Qualitee 360 in operating at the provider/sponsor intersection with curated specialty data.
• Definitive Healthcare: Healthcare commercial intelligence provider offering provider, procedure, and sales-data analytics to medtech and life sciences companies. Adjacent to Qualitee 360's provider targeting and product value-analysis work for medical device manufacturers.

Others

• ASMBS MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program): Joint ACS/ASMBS quality program that sets standards, collects outcomes data, and accredits bariatric surgery centers. Operates in the same bariatric quality-improvement ecosystem where Qualitee 360 runs its specialty collaboratives and PSO work.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/profile.php

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Qualitee 360