Parameters Research Laboratory, Inc.

What Parameters Research Laboratory, Inc. does

Parameters Research Laboratory, Inc. (PRL) is a clinical research organization (CRO) headquartered in Broomfield, Colorado, that designs and executes validation studies for medical device and wearable physiological monitoring developers. The company offers full-service clinical research spanning protocol design, IRB oversight, Case Report Form and Informed Consent Form development, data collection with gold-standard reference methods, Source Data Verification, risk-based monitoring under ICH E6(R2), statistical analysis, and regulatory submission support for FDA, ISO, and international standards. Studies are conducted under Good Clinical Practice with IRB oversight and aligned to ISO 14155 and 21 CFR Part 50.

PRL's service portfolio is specialized in vital-signs validation, including cuff-based blood pressure device studies, cuffless blood pressure device studies, pulse oximetry and controlled desaturation hypoxia studies, and multi-parameter physiological monitoring studies. The company executed the multi-site clinical study that supported the first U.S. FDA over-the-counter clearance for a cuffless blood pressure monitor (Hilo by Aktiia), establishing a regulatory precedent for the wearable-cuffless category. Principal Investigator Dr. Arthur Cabrera actively participates on the ISO 81060-7 and ISO 81060-3 international standards committees that define validation requirements for cuffless blood pressure devices.

The business operates as a B2B professional services CRO, selling project-based engagements directly to medical device manufacturers and wearable technology developers through enterprise field sales. Pricing is quote-based and project-specific depending on study scope, complexity, and regulatory pathway; no standard pricing is publicly disclosed. Revenue is generated through clinical study contracts with named sponsors across enterprise (Midmark Corporation, SRA Samsung), consumer health-tech (Hilo by Aktiia), nonprofit (American Medical Association), and startup segments (Venavitals, KehaAI, Sage Research). PRL is privately held, founder-led, with no disclosed institutional funding, and operates with 1-10 employees.

Name

Parameters Research Laboratory, Inc.

Legal name

Parameters Research Laboratory, Inc.

Website

https://parameterslab.com

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

1–10 employees

Short description

Parameters Research Laboratory (PRL) is a Broomfield, Colorado-based clinical research organization that designs and executes GCP-compliant validation studies for medical device and wearable physiological monitoring developers, specializing in cuff-based and cuffless blood pressure, pulse oximetry, and hypoxia studies.

Ownership category

akta.pro rank

Product category

Clinical Research Organization (Medical Device CRO)

NAICS

Testing Laboratories and Services (54138), Scientific Research and Development Services (5417)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industry

Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG)

Keywords

• Clinical research organization
• Medical device validation
• Blood pressure studies
• Pulse oximetry studies
• Regulatory compliance services

Headquarters

HQ city

Broomfield

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations

Revenue model

1. Clinical Research Services: Full-service clinical research organization providing medical device validation studies for wearable technology and physiological monitoring device developers. Services include protocol design, participant recruitment, data collection, monitoring, analysis, and regulatory submission support for FDA, ISO, and international standards compliance.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Parameters Research Laboratory (PRL) is a full-service clinical research organization (CRO) providing medical device validation studies for wearable and physiological monitoring technologies. Its services cover the full study lifecycle—protocol design, CRF/ICF development, participant recruitment, IRB-compliant study execution under GCP, data collection and source data verification, statistical analysis, and regulatory submission support for FDA, ISO 14155, and international standards. Core study types include controlled desaturation/hypoxia studies, cuff-based and cuffless blood pressure device studies, pulse oximetry studies, and multi-parameter physiological monitoring studies.

Product overview

Parameters Research Laboratory (PRL) is a full-service clinical research organization (CRO) specializing in medical device validation studies for wearable and physiological monitoring technologies. The company offers a unified portfolio of clinical research services encompassing protocol design, IRB oversight, CRF/ICF development, data collection, statistical analysis, and regulatory submission support. The core service offering includes specialized study types: controlled desaturation hypoxia studies, cuff-based blood pressure device studies, cuffless blood pressure device studies, pulse oximetry studies, and multi-parameter studies—all conducted under GCP with IRB oversight. PRL's expertise is particularly focused on blood pressure monitoring validation, having supported the first FDA-cleared over-the-counter cuffless blood pressure monitor (Aktiia Hilo).

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Research Services Comprehensive clinical research services for medical device validation, including protocol design, IRB oversight, data collection, statistical analysis, and regulatory submission support for FDA, ISO, and international standards. Intended for medical device manufacturers and wearable technology developers.
• Cuff-Based Blood Pressure Device Studies Clinical validation studies for traditional cuff-based blood pressure monitoring devices, conducted under GCP with IRB oversight for FDA and ISO compliance. Targeted at medical device manufacturers of cuff-based BP monitors.
• Cuffless Blood Pressure Device Studies Clinical validation studies for cuffless, wearable blood pressure monitoring technologies, including the study that supported FDA clearance of the first over-the-counter cuffless blood pressure monitor (Aktiia Hilo). Targeted at wearable health technology developers and medical device manufacturers of cuffless BP devices.
• Pulse Oximetry / Hypoxia Studies Studies validating pulse oximetry and related physiological monitoring devices, including controlled desaturation hypoxia studies conducted under GCP with IRB oversight that test device performance under low-oxygen conditions. Targeted at medical device manufacturers of pulse oximeters and respiratory monitoring devices.
• Controlled Desaturation Hypoxia Studies Controlled desaturation hypoxia studies conducted under GCP with IRB oversight, testing device performance under low-oxygen conditions. Targeted at manufacturers of pulse oximeters and respiratory monitoring devices requiring ISO-aligned hypoxia validation.
• Multi-Parameter Studies Multi-parameter physiological monitoring device validation studies that combine multiple measurement types in a single clinical study, conducted under GCP with IRB oversight. Targeted at medical device manufacturers of integrated multi-parameter physiological monitoring systems.

Named customers7 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Hilo by AktiiacoreStrategic or Co-development Partner · 1 January 2025PRL executed a multi-site clinical study across diverse U.S. populations that generated validation data for Aktiia's Hilo cuffless, wrist-worn blood pressure monitor. This study supported the U.S. FDA granting over-the-counter clearance to the Hilo device, marking the first approved cuffless blood pressure monitoring system for consumer use in the United States.
• Midmark CorporationcoreStrategic or Co-development Partner · 1 January 2024Midmark collaborated with PRL on several device-validation projects, completed on time and within budget with clear and proactive communication. PRL provided clinical rigor and expertise giving complete confidence in reliability of study outcomes.
• American Medical Association (AMA)coreStrategic or Co-development Partner · 1 January 2024AMA engaged PRL to provide expertise in blood pressure device validation testing. PRL prepared guidance outlining complexities of validation testing and clinical use of emerging technologies for cuffless blood pressure measurement to assist AMA in assessing suitability for inclusion on their Validated Device Listing (VDL, validateBP.org).
• SRA SamsungminorStrategic or Co-development PartnerMedical device research partnership with Samsung's clinical research affiliate.
• VenavitalsminorStrategic or Co-development PartnerMedical device innovation partnership in respiratory monitoring technology.
• KehaAI, Inc.minorStrategic or Co-development PartnerMedical device innovation partnership with AI health technology developer.
• Sage ResearchminorStrategic or Co-development PartnerMedical device research collaboration with research equipment company.
• ISO (International Organization for Standardization)coreStrategic or Co-development PartnerDr. Arthur Cabrera, PRL's Principal Investigator and Chief Medical Officer, actively participates on ISO 81060-7 (cuffless blood pressure devices validation) and ISO 81060-3 (continuous cuffless blood pressure measurement) standards committees, helping shape future regulatory requirements.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• IQVIA: IQVIA is the largest global CRO and life sciences services provider, with capabilities spanning clinical trials, regulatory, and technology for medical device and pharma sponsors. It competes with PRL for device-validation work but as part of a much broader portfolio.
• Charles River Laboratories: Charles River is a major CRO/CDMO offering research models, discovery, safety assessment, and clinical support. Its early-stage clinical and medical device practice creates overlap with PRL, but as a much larger, broader incumbent.
• Medpace: Medpace is a large global CRO with a sizable medical device and cardiovascular/medical imaging clinical operations practice. It is a broad incumbent — overlapping capability with PRL but operating across multiple therapeutic areas and at much larger scale.
• ICON plc: ICON is a top-five global CRO offering clinical research, medical device and diagnostics services, and post-market evidence generation. Comparable as a broad incumbent that can absorb medical-device validation studies into enterprise programs.

Direct peers

• NAMSA: NAMSA is the leading global medical device-focused CRO, offering biological safety, sterilization, and clinical research services for medical device and combination product developers. It is a direct peer because PRL operates in the same medical device clinical validation niche.
• Premier Research: Premier Research runs a dedicated medical device and diagnostics CRO practice supporting regulatory and clinical trial needs for device developers. It is directly comparable to PRL's medical-device validation focus, particularly for novel wearables and physiological monitors.
• Statistics & Data Corporation (SDC): SDC is a U.S.-based CRO with deep expertise in medical device and IVD clinical trials, biostatistics, and FDA submission support. It is directly comparable to PRL's protocol-to-submission medical device validation service.

Emerging players

• Clinipace Worldwide: Clinipace is a mid-sized, technology-enabled CRO with experience in medical device, diagnostic, and specialty clinical trials. It is an emerging peer with meaningful overlap in device-validation trial design and execution.
• WCCT Global: WCCT Global is a clinical research organization with early-phase and device-validation capabilities, including experience in vital signs and wearable device studies. Comparable in scale and niche overlap to PRL.
• George Clinical: George Clinical is an Asia-Pacific-rooted CRO with growing cardiovascular and device clinical operations globally. It is an emerging peer that competes for medical device and cardiovascular validation studies alongside PRL.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/profile.php?id=61555296376374
• LinkedInlinkedin.com/company/parameters-research-laboratory-inc
• Instagraminstagram.com/parameterslab

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Parameters Research Laboratory, Inc.