Biostats CRO Directory

This is a global directory of specialised biostatistics and bioinformatics CROs serving the MedTech industry.

The goal of this site is to help medical device and diagnostics start-ups and study sponsors more easily locate niche biostatistics and bioinfomatics expertise that is tailored to their specific product development needs.

With the clinical trials industry geared heavily to pharma, it isn’t always easy for MedTech companies to find expert support in their product niche exactly when they need it. This is particularly pertinent when newer technologies require novel methods to assess their safety and effectiveness – such as algorithm validation for AI-driven products.

Embarking on a web-search and soliciting proposals from multiple company websites can be a daunting and unnecessarily time-consuming process. We hope to narrow your search early and allow you to solicit proposals from multiple companies in bulk.

To filter your exact requirements please navigate using the buttons below.

Global Listings

Anatomise Biostats (UK + AU)

Biostatistics + Bioinformatics consultancy, MedTech-focused, Boutique.

Award winning Medtech-focused biostatistics services specialising in clinical studies for medical devices, diagnostics, and SaMD, with expertise in algorithm validation and regulatory-ready statistical reporting. Global reach with dynamic ad hoc teams.

ARC Regulatory (UK)

Specialist CRO, Biomarker-focused (IVD/CDx), Boutique.

ARC Regulatory runs IVD and companion diagnostic performance studies, offering clinical monitoring, data management, and regulatory consulting. Their ARC360® platform provides self-serve guidance on global IVD/CDx compliance.

Archer Research (Belgium)

Full-service CRO, MedTech-focused, Boutique.

Supports every stage of a medical-device study, providing regulatory consulting, clinical operations, data management, and biostatistics for ISO 14155-compliant trials.

Avance (Australia)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Delivers comprehensive clinical trial management and data services across pharmaceutical and device studies. They assist sponsors with project planning, site coordination, and submission document preparation.

Avania (Netherlands)

Full-service CRO, MedTech-focused, Mid-Tier.

A specialized CRO advancing medical devices and novel health tech. Provides clinical operations and data management for medical device studies. Their services include protocol development, trial monitoring, and regulatory document support and post-market studies across multiple geographies.

Beaufort CRO (USA)

Full-service CRO, MedTech-focused, Boutique.

A niche CRO focused on medical technology, offering device trial design, usability studies, and post-market regulatory consulting for medtech sponsors.

ClinChoice (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Global full-service CRO serving pharmaceutical, biotechnology, medical device, and consumer health sectors. Jack-of-all-trades accelerating drug and device approvals. offers global trial execution and biometrics services for drug and device programs.

Clindatrix (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Provides clinical site management and data services for various therapeutic and device trials. They deliver statistical analysis and regulatory support throughout the study lifecycle.

Clinexa (Australia)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Clinexa supports trial design and data programming for both pharmaceutical and device studies. Their services include randomization, data capture, and statistical deliverables.

Clinipace (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Clinipace coordinates multi-regional clinical trials with integrated biometrics and data management. Their platform simplifies data collection and analysis for drug and device sponsors.

Devicia (Netherlands)

Full-service CRO, MedTech-focused, Boutique.

Offers clinical trial planning and execution for medical device and diagnostic studies. Handle site setup, monitoring, and data processing.

DICE CRO (Belgium)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

DICE provides clinical study design, biostatistics, statistical programming, central imaging review, and data management across Phase I–IV drug and device trials.

Fortrea (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

A full-service CRO offering clinical development for both pharmaceutical and medical device clients, with strong central lab capabilities inherited from LabCorp. Their global network supports drug and device study conduct, data management, and report generation.

Hopkins MedTech Compliance (USA)

Specialized CRO, MedTech-focused, Boutique.

A niche CRO specializing in IVD clinical performance studies, supporting quality assurance, regulatory affairs, and clinical operations for diagnostic products. Offer data collection, analysis, and submission-ready documentation.

ICON plc (Ireland)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

A jack-of-all-trades full-service CRO serving pharmaceutical, biotech, and medical device sectors, with dedicated medical device and diagnostics research units. Provide trial management, biometrics, and regulatory support for pharmaceutical and device sponsors.

IQVIA (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Primarily a biopharmaceutical-focused CRO managing Phase I–IV drug trials, with added services for medical device studies and real-world evidence. Combine analytics and trial services for drug and device development.

ISS AG (Switzerland)

Specialist CRO | MedTech-focused | Mid-Tier.

ISS AG offers clinical-operations support plus a dedicated Statistics for Clinical Studies group that provides sample-size calculation, SAP development and validated SAS® analyses for device trials.

Lindus Health (UK)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

End-to-end trial management—including protocol development, site coordination, eClinical platform services, and biostatistics—for drug, device, and diagnostic programs.

Link Medical (Norway)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Clinical trial management, regulatory affairs, data management, and biostatistics services for pharmaceutical, biotech, and medical device sponsors across Northern Europe.

MDC Associates (USA)

Consulting & CRO firm, Diagnostics-focused, Boutique.

Provides clinical evaluation and data analysis for diagnostic assays. They support study execution and regulatory dossier preparation.

MCRA (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

Full-service CRO exclusively focused on medical devices, in-vitro diagnostics, and biologics, offering integrated regulatory, clinical, biostatistics, and reimbursement services.

MakroCare (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

End-to-end clinical operations and regulatory consulting for pharmaceutical, biotech, and medical device clients, including SaMD and SiMD projects. They support study management, clinical monitoring, biostatistics, and quality services from feasibility through post-market.

Medpace (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO

A mid-sized CRO focused on biopharma, with a dedicated Medical Device & Diagnostics division providing full-service support for drug, biologic, and device trials. Clinical trial services, central lab coordination, and statistical analysis for drug and device studies.

NAMSA (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Conducts clinical investigations and laboratory services for device and diagnostic sponsors. They assist with study conduct, data management, and regulatory submissions.

Navitas CRO (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Data management, biostatistics, and project management for drug and device studies. They offer comprehensive trial support from planning through reporting.

Novineon CRO (Germany)

Full-service CRO | MedTech & Diagnostics-focused | Boutique.

Novineon manages ISO 14155/MDR clinical investigations, PMCF and performance-evaluation studies for devices and IVDs, backed by in-house Data management / Biostatistics and monitoring teams.

Parexel (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Conducts Phase I–IV trials worldwide with over 21,000 staff, providing clinical operations, data management, biostatistics, and regulatory affairs. Their global network supports drug, biologic, and device development from early-phase studies through commercialization.

Pharmexcel (UK)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Boutique.

Phase I–IV trial execution, biostatistics, and data management for NHS, academic, biopharma, and medtech sponsors.

Precision for Medicine (USA)

Full-service CRO, Diagnostics & MedTech-focused, Mid-Tier.

Designs and executes clinical studies for biomarkers and companion diagnostics. Their integrated lab and statistical services support data generation and regulatory filings.

Premier Research (USA)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Manages clinical trial operations and provides biometrics services for drug and device programs. They handle study setup, monitoring, and results analysis.

Qserve CRO (Netherlands)

Full-service CRO, MedTech-focused, Mid-Tier.

Oversees clinical investigations and regulatory consulting for device and diagnostic projects. They manage site activities, data collection, and compliance documentation.

Quanticate (UK)

Biostatistics & Programming CRO, Generalist (Pharma, Biotech & MedTech), Mid-Tier.

Statistical programming, data management, and biometrics support for global trials. They ensure CDISC compliance and generate statistical outputs for regulatory submissions.

Quantics (UK)

Biostatistics consultancy, Generalist (Pharma, Biotech & MedTech), Boutique

Statistical analysis planning and model development for clinical studies. Services include sample size calculation, data programming, and report writing.

RQM+ (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

A global MedTech CRO offering comprehensive device trial services. RQM+ combines regulatory/quality consulting with clinical trial management to navigate the full product lifecycle for medical device and IVD companies

SDC (Statistics & Data Corporation, USA)

Specialty CRO, Biostatistics & Data Management, Mid-Tier.

Biostatistics, data management, EDC/IRT, and clinical operations services to pharmaceutical, biologic, and device sponsors. Founded in 2005.

SGS Life Sciences (Switzerland)

Full-service CRO, Generalist (Pharma, Biotech & MedTech), Mega-CRO

End-to-end clinical research and bioanalytical services—spanning study design, trial management, data management, biostatistics, and clinical laboratory testing—for pharmaceutical, biotechnology, and medical device sponsors.

Syneos Health (USA)

Full-service CRO & CCO, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Serving mainly pharmaceutical and biotech clients. Integrates clinical trial execution with commercialization services for drug, device, and diagnostic products. Offer patient engagement, data analytics, and market strategy support.

Veramed (UK)

Full-service CRO, Diagnostics-focused, Boutique.

Conducts clinical performance and usability tests for diagnostic devices. They prepare study reports and regulatory documents for CE and FDA submissions.

Veranex (USA)

Full-service CRO, MedTech-focused, Mid-Tier.

Site feasibility, study monitoring, and statistical analysis for device development. They help sponsors prepare regulatory submissions for global markets.

Veristat (USA)

Biostatistics consultancy, Generalist (Pharma, Biotech & MedTech), Mega-CRO.

Provides statistical study design, data analysis, and reporting for clinical trials across sectors. Their consultancy approach offers tailored support for complex study needs.

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