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?
Partnering with a MedTech-specialised biostatistics CRO can give device and diagnostic sponsors a tangible edge. Because these firms live and breathe ISO 14155 and EU MDR/IVDR, their statisticians design studies around device-specific endpoints and objective performance criteria, reducing the risk of protocol rework and regulatory queries. Their narrower client roster and boutique operating models usually translate into shorter communication chains and faster turnaround on SAP revisions, interim analyses, and DMC requests—an agility that can shave weeks off a development timeline. For projects that hinge on performance-goal or single-arm designs common in device trials, a MedTech-focused CRO’s innovative statistical toolkit helps generate fit-for-purpose evidence without over-enrolling patients. In short, when the study revolves around devices, diagnostics, or SaMD, a specialist biostatistics CRO aligns methodology, compliance, and project cadence more tightly with regulators’ expectations than a broad, full-service provider—ideally yielding cleaner data and quicker paths to approval.
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