FRANKLYN HEALTH LTD

What FRANKLYN HEALTH LTD does

Franklyn Health Limited is a private, employee-owned European Clinical Research Organisation founded in 2025 and headquartered in Leeds, United Kingdom (Lister House, Lister Hill, Horsforth, LS18 5AZ), with a regional office in Barcelona, Spain. The company delivers a full-service CRO offering for medical device and in vitro diagnostic manufacturers, spanning regulatory strategy, study design and protocol authorship, study startup, site selection and monitoring, clinical study management, data management and biostatistics, and medical writing. Services are designed to satisfy EU MDR, IVDR, FDA, and UKCA requirements across the device lifecycle, from first protocol through post-market clinical follow-up, with reporting scale of 50+ EU/FDA protocols written, 100+ clinical investigations led, 25+ devices brought to market, and 10,000+ patients enrolled (figures presented as cumulative operating track record).

The company's underlying technology stack combines a proprietary AI-powered regulatory intelligence tool — described as a novel-method architecture for accelerating study startup, document quality, and cross-jurisdiction navigation — with a strategic EDC partnership with Ledidi (validated for GCP, FDA 21 CFR Part 11, ISO 27001, and SOC 2 Type II) and complementary evidence-management integrations including Mantra Systems. Supporting infrastructure consists of direct sales-led distribution, Calendly-enabled consultation booking, and a content/LinkedIn/event-led top-of-funnel motion with no intermediary resellers.

Franklyn Health generates revenue through professional service fees for project-based engagements, with transparent, tailored pricing and multi-year contracts; specific price points are not publicly disclosed. The target customer is small and midsize medtech device and diagnostic manufacturers worldwide, with an explicit positioning against large CROs on responsiveness, transparency, and MedTech specialisation. The leadership team consists of Co-founder & CEO Rob Bedford (prior J&J, Stryker, QIAGEN, Smith+Nephew), Co-founder & Director of Regulatory & Startup Laura Van Vaeck (prior ICON, IQVIA), Co-founder & Finance Director Daniel Madsen (prior Danske Bank), and Senior Strategic Advisor Michael Branagan-Harris (appointed January 2026; prior Device Access UK, VNUS Medical Technologies UK, Covidien). Named logos on company materials include Stryker, Smith+Nephew, DePuy Synthes, Johnson & Johnson, QIAGEN, Novartis, AbbVie, IQVIA, and Labcorp. No external funding rounds, subsidiaries, or parent entities are disclosed.

Name

FRANKLYN HEALTH LTD

Legal name

Franklyn Health Limited

Website

https://franklynhealth.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

1–10 employees

Short description

Franklyn Health is an employee-owned European CRO providing regulatory strategy, clinical trial design and execution, data management, biostatistics, and medical writing for small and midsize medical device and in vitro diagnostic manufacturers worldwide, combining proprietary AI-powered regulatory tooling with deep MDR/IVDR/FDA/UKCA expertise.

Ownership category

akta.pro rank

Product category

Medical Device Clinical Research Services (CRO)

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Health Services (8000)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Clinical research services
• Medical device CRO
• Regulatory strategy
• Clinical study management
• Biostatistics services

Headquarters

HQ city

Leeds

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Franklyn Health operates as a full-service CRO providing end-to-end clinical research services for medical device and diagnostic manufacturers, from first study design through regulatory submission and post-market follow-up. Revenue is generated through professional service fees for regulatory strategy, study design, study startup, site selection, monitoring, data management, biostatistics, and medical writing. The company offers transparent, tailored pricing with adaptable models aligned to project needs.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Franklyn Health is a full-service European Clinical Research Organisation (CRO) that delivers end-to-end clinical research, regulatory strategy, and data services for medical device and in-vitro diagnostic manufacturers. Services span regulatory strategy (MDR, IVDR, FDA, UKCA, CE), study design and protocol, study startup, site selection and monitoring, clinical study management, data management and biostatistics, and medical writing, from first study design through regulatory submission and post-market follow-up. The company combines proprietary AI-powered regulatory intelligence with senior medtech expertise to accelerate study startup and reduce costs.

Product overview

Franklyn Health is a full-service European Medtech Clinical Research Organisation (CRO) offering a comprehensive suite of clinical research services for medical device and diagnostic manufacturers. The company's service portfolio includes Regulatory Strategy (covering MDR, IVDR, FDA, UKCA, CE requirements), Study Design & Protocol development, Study Startup management, Site Selection & Monitoring, Clinical Study Management, Data Management & Biostatistics, and Medical Writing. As an employee-owned company, Franklyn Health leverages proprietary regulatory intelligence technology and partnerships with platforms like Ledidi (EDC/evidence management) to deliver faster study startup, higher quality, and reduced costs. The services are designed for small and midsize device or diagnostic manufacturers worldwide, providing the consistency and responsiveness that large CROs cannot match.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy Guides medical device and diagnostic manufacturers through complex EU and global regulatory landscapes (MDR, IVDR, FDA, UKCA, CE) from early classification and intended use definition through clinical evidence planning and submission pathways. Targeted at small and midsize medtech and diagnostic manufacturers worldwide.
• Study Design & Protocol Designs practical clinical studies for medtech and diagnostic products that balance science and regulation, translating regulatory and clinical needs into robust, compliant protocols covering biostatistics, endpoints, and site and patient considerations.
• Study Startup Manages site contracts and regulatory/ethics submissions for medtech clinical studies to increase quality, avoid delays, and reduce costs, leveraging in-country experts and proprietary AI-powered regulatory tools to accelerate approvals.
• Site Selection & Monitoring Selects high-performing investigators with access to the right patient populations and provides proactive monitoring oversight to safeguard patient safety, ensure protocol adherence, and maintain data integrity for medtech and diagnostic studies.
• Clinical Study Management Provides hands-on leadership for global device and diagnostics studies across multiple countries, with comprehensive oversight of teams, sites, data, budgets, and safety throughout the trial for medtech manufacturers.
• Data Management & Biostatistics Builds efficient databases, manages queries, ensures data integrity, and provides expert biostatistics integrated at every stage from protocol design through regulatory submissions for medical device and diagnostic clinical studies.
• Medical Writing Creates audit-ready clinical and regulatory documents for medtech and diagnostic manufacturers including protocols, Investigator's Brochures, informed consent forms, evaluation plans, study reports, and regulatory submissions meeting MDR, IVDR, FDA, and UKCA requirements.

Quantifiable outcome

• 50+ EU and FDA protocols written; 100+ clinical investigations executed; 25+ devices brought to market; 10,000+ patients enrolled to date

Named customers9 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature1 record

Partnerships

Four partnerships are on record, tiered core and minor.

• LedidicoreTechnology or IntegrationFranklyn Health partners with Ledidi, a modern EDC (Electronic Data Capture) and evidence management platform. Ledidi provides a secure, validated, cloud-based environment for clinical data that meets GCP requirements and FDA 21 CFR Part 11, with ISO 27001 and SOC 2 Type II certification. The partnership enables rapid study build, clean data capture, and collaborative workspace where sponsors, CRO teams, and investigators can work together in real time with shared visibility.
• MediLifecoreStrategic or Co-development PartnerFranklyn Health co-delivered a webinar with MediLife as part of BCN Health Innovation Week, powered by Biocat, BioRegion of Catalonia. The collaboration combined clinical research and market access expertise to help MedTech companies design studies that support both regulatory approval and commercial success. Franklyn Health team members Rob Bedford and Laura Van Vaeck were joined by Ian Galloway and Alistair Kirby from MediLife.
• Pioneer GroupminorGTM or Marketing PartnerFranklyn Health CEO Rob Bedford was invited to speak at the Pioneer Group Launch Programme Accelerator, sharing expertise with emerging MedTech and life sciences startups on US market access and FDA regulatory pathways.
• Biocat (BioRegion of Catalonia)minorGTM or Marketing PartnerFranklyn Health participated as a speaker and partner in BCN Health Innovation Week, powered by Biocat, BioRegion of Catalonia, connecting with the regional MedTech and digital health ecosystem.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Lindus Health: Tech-enabled clinical trial CRO for digital health, medical device, and consumer health studies. Highly comparable as an emerging, technology-forward CRO targeting small and midsize medtech and digital health sponsors.

Others

• Clario: Clinical trial technology and endpoint data science provider serving CROs and sponsors, including EDC and eCOA capabilities. Relevant adjacent peer given Franklyn Health's partnership with Ledidi and its emphasis on EDC/evidence management workflows.

Broad incumbents

• Charles River Laboratories: Large CRO and preclinical/research services provider with medtech and diagnostics exposure. Relevant comparable for Franklyn Health's regulated clinical evidence generation and study management services.
• Parexel International: Global CRO with strong regulatory and clinical capabilities across medical devices, diagnostics, and pharma. Competes for the same mid-market medtech clinical study and regulatory submission work that Franklyn Health targets.
• Labcorp Drug Development (Fortrea): Large global CRO spun out of Labcorp, offering end-to-end clinical development services including medtech and diagnostic studies. Direct competitor for mid-size and enterprise medtech sponsors, and also a named partner/customer of Franklyn Health.
• IQVIA: World's largest CRO with comprehensive clinical, regulatory, and real-world evidence services across pharma, biotech, and medtech. Listed as both a former employer of Franklyn Health leadership and a customer, IQVIA represents both the benchmark and the primary competitive threat.

Direct peers

• ICON plc: Global full-service CRO offering clinical research, regulatory, and biostatistics services across therapeutic areas including medical devices. Franklyn Health co-founder Laura Van Vaeck previously worked at ICON, making it a direct comparable and likely competitor for medtech clients.
• Medpace: Mid-size, full-service CRO known for its science-led, sponsor-dedicated model targeting small and midsize biopharma and device sponsors. Highly comparable to Franklyn Health's positioning of focused, senior-led, full-service clinical research for smaller medtech clients.
• Worldwide Clinical Trials: Mid-size, science-focused global CRO with medtech and rare disease expertise. Comparable to Franklyn Health in its mid-market, full-service clinical research positioning and senior-led study teams.
• Premier Research: Mid-size CRO with strong medical device, diagnostics, and rare disease franchises, focused on small and midsize sponsors. Direct comparable to Franklyn Health in segment focus and full-service medtech clinical delivery.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/franklyn-health

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 FRANKLYN HEALTH LTD