Clinical performance studies are where diagnostic programmes lose the most time: slow ethics approvals, sites that under-recruit and endpoints that do not match the claims in your instructions for use.
Clinical trials and CRO services
Abingdon Analytical provides diagnostics-focused CRO services that link your clinical study to the analytical data generated in our laboratory, so protocols, sample handling and statistics are designed around one submission from the outset. Our clinical evaluation services assess device safety and performance when used as intended.
Study design
Whether you are preparing a technical file for CE mark submission or an FDA 510(k), De Novo or CLIA waiver application, we design the performance evaluation studies you need around the approvals you are seeking: population, comparator, sample size and statistical analysis plan, agreed before enrolment and referenced to ISO 20916 good clinical performance study practice, where applicable (for IVDs).
For veterinary diagnostics developers, we deliver field studies that show performance in the target species and setting, applying the same study design discipline as our human diagnostics work.
Site network
We run validation and verification studies through a network of accredited clinical trial sites across the US, EU and UK, selected for access to your target population and intended use setting. Recruitment feasibility is tested before sites are contracted, not after enrolment falls behind.
Accredited clinical trial sites, supported by Abingdon Health's commercial office and laboratory in Madison, Wisconsin.
Accredited clinical trial sites selected for your target population and intended use setting.
Accredited clinical trial sites, linked to the analytical work in our Doncaster laboratory.
Our CRO services
Each service is available on its own or as part of a full study, managed by one project lead with one timeline and one data trail.
| Service | The problem it will prevent |
|---|---|
| Medical writing | Protocols and reports that do not map to your claims or technical file |
| Regulatory & ethics approval | Avoidable review cycles that push back first enrolment |
| Country & site feasibility | Sites selected on availability rather than access to the right population |
| Study & site start-up | Weeks lost to contracts, training and sample logistics |
| Clinical monitoring & project management | Protocol deviations found at close-out instead of in real time |
| Biostatistics & data management | Underpowered studies and data sets that cannot be defended |
| Quality assurance | Audit findings that call the study data into question |
| Post-market performance follow-up (PMPF) | Gaps in post-market evidence required under IVDR |
After CE marking
Under IVDR, evidence generation continues after CE marking. We can plan and run post-market performance follow-up (PMPF) studies that confirm device performance in routine use and feed your post-market surveillance (PMS) reporting, using the same protocols and data standards as your pre-market work.
From the Knowledge Centre
Practical guidance from the specialists who deliver this work every day.
Article
Performance Evaluation for FDA 510(k): Building Your Substantial Equivalence Case
What FDA 510(k) performance evaluation requires and how to build a strong case for substantial equivalence in IVD submissions.
Also worth reading
Article
Clinical Trials with Lateral Flow Tests: Key Considerations
Article
Smarter, Faster, Further: Engineering the Next Generation of Point of Care Diagnostics
Article
Breaking Down Analytical Performance Studies under IVDR: Methodologies and Best Practices
Article
Companion Diagnostics: Playing 5D Chess in Regulatory Development
Case study
Abingdon Health is proud to partner with 4TEEN4 Pharmaceuticals in developing a first-of-its-kind companion diagnostic for treating life-threatening shock.
Frequently asked questions
We support medical device and IVD manufacturers with clinical trial planning, study management, performance studies, evidence generation and regulatory submission support. Our clinical services are designed to generate the data required for performance evaluation, clinical evaluation and market access activities.
A Contract Research Organisation (CRO) provides specialist support for the planning, management and execution of clinical studies. CRO services can include protocol development, site management, regulatory submissions, data collection and study oversight to help sponsors generate clinical evidence efficiently.
Clinical trials generate evidence demonstrating safety, clinical performance and intended use in the target population. This evidence can support FDA submissions, EU MDR compliance, IVDR performance evaluation requirements and broader market access activities.
A clinical evaluation assesses available clinical evidence to demonstrate product safety and performance, while a clinical trial generates new clinical data through a structured study. Depending on the product and regulatory pathway, manufacturers may require one or both approaches to support regulatory approval.
Clinical trial requirements depend on the device classification, intended use, available evidence and applicable regulations. Early assessment of clinical evidence requirements can help determine whether additional clinical investigation or performance study data will be needed for regulatory approval.
Clinical trial data can be used to support clinical evaluation reports, performance evaluation reports, technical documentation and regulatory submissions. Strong clinical evidence can strengthen regulatory approvals and support commercial adoption in regulated markets.
Start the conversation
Talk to our team about protocol design and site feasibility.