CRO · Device trials
Medical device clinical trials — exploratory through confirmatory
AriBnC designs, runs, monitors and reports exploratory and confirmatory medical device studies from its Yongin head office and laboratory. The researcher who writes the protocol builds the EDC and the case report form, and the statistician who writes the analysis plan runs the analysis and the report. We have been a KoNECT-registered CRO since April 2023 and have run exploratory and confirmatory device studies.
- Exploratory and confirmatory device studies run · Digital therapeutic clinical trial plan approval (MFDS, 2024)
- KoNECT-registered CRO (Apr 2023)
- EDC build and operation, CRF design and biostatistics in-house (Yongin)
Exploratory and confirmatory studies
What each kind of study settles, and how much of it AriBnC takes on
A medical device study is exploratory or confirmatory depending on what it is meant to settle. An exploratory study checks how the device is used, under what measurement conditions, and whether the endpoints and the assumptions behind the sample size hold. A confirmatory study tests performance or safety against a primary endpoint fixed in advance. AriBnC works on both, from protocol design through the clinical study report.
Design, biostatistics and data work are done in-house at the Yongin head office and laboratory. We build and operate the EDC study by study, and the same team writes the CRF and the data validation rules, so the endpoint definitions in the protocol carry straight through to the entry screens and the checks run against them. The time reference used to reconcile exported device log data with case report form data is agreed while the protocol is being finalised.
The same laboratory also runs drug trials and health functional food human application studies, so on device studies too, consent handling, monitoring records, deviation processing and database lock follow one set of procedures, run by one team.
Site selection and contracting, IRB review and the MFDS clinical investigation plan approval route differ by device class and application type.
What the device-trial work covers
What AriBnC takes on
Protocol and endpoints
We translate the study objective into endpoints and document the primary and secondary endpoints, measurement timepoints and the basis for the sample-size calculation. Assumptions are first tested against the sponsor's own data and published literature; where the basis is thin, we propose a small exploratory study before the confirmatory one.
IRB and MFDS submission documents
We assemble the IRB review package and the clinical investigation plan dossier, and respond to deficiency requests. Those responses are written by the same team that handles the protocol and the source data.
Regulatory affairsSites and subject recruitment
We propose candidate sites that fit the device and the recruitment criteria, and manage site contracting, IRB scheduling and recruitment progress.
Monitoring and deviation control
The visit plan and the extent of source data verification (SDV) are fixed together with the protocol; visit reports, queries and protocol deviations are recorded throughout the study. Device dispatch, return and inventory records are kept within the same documentation system.
EDC build and data management
We build and operate the EDC for each study and write the CRF and the validation rules. The procedure and the time reference for reconciling exported device log data with EDC data are written into the protocol.
Yongin research instituteStatistical analysis and study report
The statistical analysis plan is fixed before database lock, and the statistician who wrote it runs the analysis and writes the clinical study report. Results are described only within the endpoints defined in advance.
Designing studies for continuous-measurement and wearable devices
A study of a device that is worn for a period and records values continuously — a continuous glucose monitoring system (CGMS) is one example — is designed differently from one that measures at each visit. Because readings from the device are compared pair by pair with values from a reference measurement across the wear period, the schedule, staffing and data handling are set up differently from the start.
How many paired readings are collected, and when, governs how the results can be read. The sampling and measurement interval, the spread of data across the measurement range, time synchronisation between device logs and EDC records, and the handling of missing intervals are written into the protocol in advance.
- A paired design against the reference measurement, with the sampling and measurement schedule
- Time synchronisation and reconciliation between device log data and EDC data
- A plan for obtaining data across the full measurement range, including the low and high ends
- Missing intervals, error values and device replacement or re-application events defined up front, with handling rules
- Accuracy metrics and acceptance criteria are fixed at project start according to the device and the application type
Agreed before the design is fixed
Where a project can be picked up is set out by development stage on the CRO and regulatory services overview.
Deliverables by stage, and what the sponsor provides
A standard split, adjusted at contract.
| Stage | AriBnC deliverables | Sponsor provides |
|---|---|---|
| Kick-off | Study outline, division of responsibilities, draft schedule | Device description, class and application type, existing study data |
| Design | Protocol, draft statistical analysis plan, sample-size rationale, CRF design | Instructions for use, performance specification, use conditions, log export format |
| Approvals and contracts | IRB package, clinical investigation plan dossier, site contracting support | Device supply plan, evidence of subject injury compensation insurance, a named technical contact |
| Conduct | Monitoring plan and visit reports, EDC and CRF operation, query and deviation records | Supply of devices and consumables, technical support, notification of device faults |
| Close-out | Database lock, statistical results, clinical study report, document handover list | Review comments, the follow-on submission schedule, agreement on record retention |
Duration and cost depend on the number of subjects, the number of visits, the number of sites and device supply terms, so they are quoted in a separate proposal after a scoping call.
Frequently asked questions
Can we go straight to a confirmatory study without an exploratory one?
It depends on the device and the data you already hold. We first assess whether existing data can support the endpoints and the assumptions behind the sample size; if the basis is thin, we propose a small exploratory study. The assessment and its rationale are recorded in the kick-off document.
How are our company name and study details handled?
Sponsor names and study details are handled under a non-disclosure agreement, and documents are exchanged only once that agreement is in place.
Can the study support a submission outside Korea?
Tell us the purpose and the target countries at the design consultation — that is what lets us build the document structure and the study design to match. Whether an international standard such as ISO 14155 applies is settled at the same point.
Request a medical device study consultation
Device type and target timing are enough to start. A member of our team will review and reply.