Medical device clinical trials are driven by performance, usability, and risk, rather than fixed development phases.
For device companies, regulatory delays and challenges are frequently caused not by recruitment volume, but by unclear endpoints, weak data traceability, or evidence that is not aligned to device classification or intended claims.
Quanticate provides focused biometric expertise to help medical device companies generate clear, proportionate, and regulatory-ready clinical evidence across the device lifecycle, without forcing a pharmaceutical trial model onto device development.
CRO Services for Medical Device Companies
Biostatistics
Understand your drug’s/device’s efficacy and safety profile with expert statistical analysis of your clinical research data.
Biostatistical Consultancy
Ensure efficient trial designs, analysis and study planning to streamline your clinical development efforts to reduce costs and save time.
Statistical Programming
Turn un-interpretable validated clinical data into something meaningful with clinical trial reporting to make informed decisions and submission ready deliverables.
Clinical Data Management
Flexible and modern data collection, capture and management methods for your research data to ensure error free and timely database locks in line with the latest regulatory guidance.
Medical Writing
Give your regulatory submission the best chance for approval with well written regulatory documents throughout all stages of the drug development process.
Pharmacovigilance
Quanticate offers a fully compliant and high-quality complete package of pharmacovigilance services.
ISS/ISE Submissions
Ensure data standardisation and regulatory compliance to accelerate submission and approval processes.
Real World Evidence
Harness insights that support health economics and outcomes research (HEOR) through our specialist team support with observational studies and post-approval safety research.
What challenges and pain points do medical device companies face?
Medical device companies operate in a diverse, risk-based regulatory environment. Devices range from low-risk products with limited clinical requirements to complex implantable, interventional, or software-enabled technologies requiring robust, prospectively collected evidence. Determining what evidence is required, and how to generate it efficiently, is a key challenge.
Many device organisations are engineering- or innovation-led, with clinical capability introduced later in development or distributed across small teams. This often increases reliance on external partners for clinical evidence planning, data governance, and regulatory-ready outputs.
Device development is also inherently iterative. Design changes, usability refinements, and manufacturing updates can occur alongside clinical evaluation. Without strong biometric oversight, these changes can undermine traceability and weaken the credibility of the evidence.
For many device programmes, biometrics is an effective point of consolidation. Partnering with a specialist biometric CRO such as Quanticate allows device companies to centralise data management, statistics, programming, medical writing, and pharmacovigilance under a single governance model, while retaining flexibility in how clinical operations are delivered.
Frequently Asked Questions
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How do medical device clinical trials differ from drug trials?
Medical device trials are shaped by device classification, intended use, and risk profile rather than fixed clinical phases. Endpoints often focus on performance, usability, and durability, and evidence generation frequently continues after approval through post-market follow-up.
When do medical device companies work with CROs?
Medical device companies work with CROs when they need specialist expertise, scalable resource, or independent oversight to design and deliver clinical studies efficiently, particularly when internal clinical capability is limited or evolving.
Why choose a specialist biometric CRO for medical device trials?
While a full-service clinical CRO can simplify governance, biometrics plays a central role in demonstrating device performance, safety, and regulatory compliance. A specialist biometric CRO brings focused expertise in data quality, statistical design, and reporting, helping medical device companies generate credible, traceable evidence across the device lifecycle while working alongside clinical partners.
