CRO · Drug trials
Drug clinical trials
For Phase 2 and Phase 3 drug trials we design the protocol, manage and monitor sites, run EDC-based data management, perform biostatistics and prepare MFDS submission documents. Study design, biostatistics, EDC build and operation and case report form (CRF) design are carried out in-house at the Yongin head office laboratory, and we take both full-service assignments and single work packages. AriBnC has been registered as a CRO with KoNECT since April 2023.
- CRO registered with KoNECT — April 2023
- Design, biostatistics, EDC build and operation and CRF design done in-house in Yongin
- Drug trials, health functional food human studies and device trials handled by the same design, statistics and data management staff
What the drug-trial work covers
For drug trials, AriBnC covers study design, site management and monitoring, data management, biostatistics and regulatory submission documents.
Drug trials, health functional food human application studies and medical device trials are handled by the same design, biostatistics and data management staff at the Yongin head office laboratory. The applicable rules and the deliverables differ by study type, but the design conventions and the statistics and data management practice carry across from one to the next. Because the MFDS submission work sits inside the same company, the structure of the submission can be reviewed while the study is still being designed. The scope of our overseas regulatory work is described on the regulatory affairs page.
We take both full-service assignments and single work packages — biostatistics only, or EDC build, operation and data management only. In every case we review the available documents first and fix scope and timeline in writing before contracting.
Scope of work
We perform all or part of this, depending on the contracted scope.
Protocol and study design
Choosing a design that fits the objective, defining endpoints, calculating sample size, drafting the protocol and the case report form (CRF). Study design and CRF design are both performed at the Yongin head office laboratory.
Site management
Site feasibility review, acting as the contact point for investigators and site staff, support in assembling IRB submission documents, enrolment tracking.
Monitoring
Initiation, routine and close-out visits, source data verification (SDV), a monitoring report for each visit, follow-up until findings are corrected.
Data management
EDC build and operation, CRF screen implementation, edit-check rules, query handling and database lock — carried out at the Yongin head office laboratory.
Biostatistics
Statistical analysis plan (SAP), analysis datasets, the analysis itself, output tables and the statistical sections of the study report.
Regulatory submission support
Assembling MFDS submission documents and supporting responses to deficiencies.
Regulatory affairsHow a project runs
From the pre-start review to handover of the study report.
- 01
Initial review
- Review of what you already have — development background, nonclinical data, earlier clinical data
- Detailed review proceeds once a confidentiality agreement is in place
- Scope, timeline and quotation returned in writing
- 02
Design
- Design, endpoints and sample size fixed
- Draft protocol, CRF and statistical analysis plan
- Review of candidate sites and feasibility
- 03
Preparation
- Support in assembling IRB and MFDS submission documents
- EDC build, edit-check configuration and CRF screen implementation
- Monitoring plan and materials for site staff
- 04
Conduct
- Enrolment and schedule tracking with regular reporting
- Monitoring visits and source data verification (SDV)
- Review of data entry status and query resolution
- Operating the safety information routing path — the sponsor remains the reporting party and makes the assessments
- 05
Close-out
- Database lock
- Statistical analysis and output tables
- Clinical study report (CSR)
- Handover of records and confirmation of what is archived where
Track record
Once a confidentiality agreement is in place, we can share study type, the number of subjects, the work we performed and its duration, within what our existing contracts allow.
- Design, biostatistics, EDC build and operation and CRF design performed at the Yongin head office laboratory — any work that must be subcontracted is specified, with its scope, before contracting
- Exploratory and confirmatory device studies are described on the medical device trials page
Division of roles and deliverables
A typical division of roles for a full-service assignment.
| Stage | AriBnC | Sponsor | Key deliverables |
|---|---|---|---|
| Design | Design selection and sample size, draft protocol, CRF and SAP | Development background, nonclinical and earlier clinical data | Protocol, CRF, statistical analysis plan |
| Preparation | Support in assembling submission documents, EDC build, monitoring plan | Investigational product supply, decisions and signatures as the filing party | EDC system, monitoring plan, submission document set |
| Conduct | Site management, monitoring visits, data management and query handling | Continued investigational product supply, safety assessments and regulatory reporting | Monitoring reports, data management records |
| Close-out | Database lock, statistical analysis, study report | Review and approval of results, decisions on archiving | Statistical output tables, clinical study report (CSR) |
Frequently asked questions
Can we contract only part of the work?
Yes. Work can be contracted as single packages — biostatistics, EDC build and operation, or data management. If a study already under way is transferred to us mid-course, we first review the existing documents and the state of the systems, then fix scope and timeline.
Can we see the track record in more detail?
Yes. Once a non-disclosure agreement is in place, we share the detail at the consultation, within what our existing contracts allow.
Do you also handle health functional food human studies and medical device trials?
Yes. All three areas draw on the same design, statistics and data management staff at the Yongin laboratory, though the applicable rules and deliverables differ by study type. The scope of each is described on the health functional food human studies page and the medical device trials page.
How are cost and timeline determined?
They depend on the number of subjects, the number of visits, the number of participating sites and the number of data items collected. Send a draft protocol or a summary of the development plan and we will return scope, timeline and a quotation in writing.
Request a consultation
Send us an outline of the project; the design and statistics staff at the Yongin laboratory review it together and reply.