Find Your Biostatistics Partner
Quickly find CRO partners with the biostatistics, bioinformatics, or statistical programming expertise you need for your medical device or IVD clinical study.
Find service providers by category.
BY PRODUCT
Is your product a medical device, diagnostics, AI/SaMD or a hybrid?
BY SERVICE
Do you require biostatistics, bioinformatics or both?
For example, you may need both bioinformatics services for diagnostic biomarker discovery and biostatistics services for validation of the diagnostic.
About this Directory
This directory was born out of the frustration of trying to sort through Google search results and other directory listings that did not show categorisations relevant to MedTech.
This directory categorises biostatistics CROs by their device, diagnostic and/or AIaMD focus and a summarises whether they are full-service or analytics-based, medtech or general in focus, boutique size, mid-tier or mega CRO. With most CROs being global only the HQ location is listed alongside the company name.
The idea was too create scannable listings relevant to MedTech that don’t require you to click on the company website before you find the basics out.
Rather than painstakingly sending the same enquiry via dozens of individual website contact forms biostatscro.directory allows you to select one or more service provides in a specific sub-category and request a proposal from all in one click.
Specialist Biostatistics Support – what are some benefits?
- ISO 14155 and multi-market submissions
- FDA, EU MDR/IVDR and regional requirements
- Device-specific endpoints and performance criteria
- Performance-goal and single-arm designs
Working with a MedTech-focused biostatistics CRO can offer real benefits for device and diagnostic sponsors. These organisations work to ISO 14155 and know what each market expects — FDA guidance in the US, EU MDR/IVDR in Europe, and the requirements of the MHRA, Health Canada, PMDA, TGA and NMPA elsewhere — designing studies around device-specific endpoints and performance criteria, which can reduce protocol revisions and regulatory questions. With a streamlined approach, these CROs often provide quicker communication and faster turnarounds on study plans, analyses and requests, potentially saving time on your development timeline. For projects using performance-goal or single-arm designs, their statistical tools can help gather the necessary evidence efficiently. In short, for studies involving devices, diagnostics or SaMD, a specialist CRO can align methodology and compliance with the expectations of every market you intend to file in, leading to cleaner data and faster approvals.
Why Use This Directory?
Regulatory Expertise
MedTech-focused biostatisticians with
detailed understanding of ISO 14155, FDA
guidance, and MDR/IVDR requirements.
Agility & Speed
Quickly shortlist and compare CROs
without dialing dozens of contacts.
Tailored Methodologies
Each CRO offers methods customized to
device trials, diagnostics studies, or digital health projects.
Completely Free
It’s completely free for sponsors with
no log-in or sign-up required.
Bulk Contact
Contact multiple service providers in a
single request with the help of our
automation agent.
Browse this directory to connect directly with service providers who can meet your project needs.
Select several, ask once.Tick every CRO you want to hear from, then send one brief to all of them. Contact details stay private — your request is forwarded to each provider.
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 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.
Supports every stage of a medical-device study, providing regulatory consulting, clinical operations, data management, and biostatistics for ISO 14155-compliant trials.
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.
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.
Clinical trial design and site management across Phase I–IV for pharmaceutical, biotech, and medical device sponsors. They also provide biostatistics, data management, and regulatory strategy for both device and novel therapy studies.
A niche CRO focused on medical technology, offering device trial design, usability studies, and post-market regulatory consulting for medtech sponsors.
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.
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 supports trial design and data programming for both pharmaceutical and device studies. Their services include randomization, data capture, and statistical deliverables.
Clinipace coordinates multi-regional clinical trials with integrated biometrics and data management. Their platform simplifies data collection and analysis for drug and device sponsors.
Offers clinical trial planning and execution for medical device and diagnostic studies. Handle site setup, monitoring, and data processing.
DICE provides clinical study design, biostatistics, statistical programming, central imaging review, and data management across Phase I–IV drug and device trials.
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.
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.
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.
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.
End-to-end trial management—including protocol development, site coordination, eClinical platform services, and biostatistics—for drug, device, and diagnostic programs.
Clinical trial management, regulatory affairs, data management, and biostatistics services for pharmaceutical, biotech, and medical device sponsors across Northern Europe.
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.
Full-service CRO exclusively focused on medical devices, in-vitro diagnostics, and biologics, offering integrated regulatory, clinical, biostatistics, and reimbursement services.
Provides clinical evaluation and data analysis for diagnostic assays. They support study execution and regulatory dossier preparation.
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.
Conducts clinical investigations and laboratory services for device and diagnostic sponsors. They assist with study conduct, data management, and regulatory submissions.
Data management, biostatistics, and project management for drug and device studies. They offer comprehensive trial support from planning through reporting.
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.
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.
Phase I–IV trial execution, biostatistics, and data management for NHS, academic, biopharma, and medtech sponsors.
Designs and executes clinical studies for biomarkers and companion diagnostics. Their integrated lab and statistical services support data generation and regulatory filings.
Manages clinical trial operations and provides biometrics services for drug and device programs. They handle study setup, monitoring, and results analysis.
Oversees clinical investigations and regulatory consulting for device and diagnostic projects. They manage site activities, data collection, and compliance documentation.
Statistical programming, data management, and biometrics support for global trials. They ensure CDISC compliance and generate statistical outputs for regulatory submissions.
Statistical analysis planning and model development for clinical studies. Services include sample size calculation, data programming, and report writing.
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.
Biostatistics, data management, EDC/IRT, and clinical operations services to pharmaceutical, biologic, and device sponsors. Founded in 2005.
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.
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.
Conducts clinical performance and usability tests for diagnostic devices. They prepare study reports and regulatory documents for CE and FDA submissions.
Site feasibility, study monitoring, and statistical analysis for device development. They help sponsors prepare regulatory submissions for global markets.
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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