Process
From first enquiry to delivery
A commission proceeds through the six stages below. There is no charge up to and including the return of a proposed design.
Stage by stage
Consultation — no charge
Tell us about the test material, the function you wish to demonstrate, any data you already hold (compositional, cell, animal), and your indicative schedule and budget. We reply with whether one or more feasible designs exist and, if so, what form they would take. Trade-secret information is not requested at this stage.
Protocol design — begins after contract
The primary and secondary endpoints are fixed and the sample size derived from a power calculation based on prior data. Inclusion and exclusion criteria, dose and duration, the visit schedule and adverse event procedures are documented, together with a draft statistical analysis plan (SAP).
IRB support
We prepare the full submission package — protocol, participant information sheet and consent form, case report forms and recruitment notices — and respond to any requests for revision. No recruitment or data collection begins before approval.
Conduct
Participants are recruited and visits, dosing and sample collection proceed according to the approved protocol. Missing data, withdrawals, compliance and adverse events are monitored and recorded on a fixed schedule, and progress is reported to the sponsor at regular intervals.
Statistical analysis
After database lock the data are analysed according to the pre-specified SAP. Definitions of the ITT and PP populations, the handling of missing data and any multiplicity adjustment are fixed in advance and are not changed once the results are seen. Mediation analysis is added where the design calls for it.
Reporting and publication
We produce a study report or clinical study report (CSR). Where publication is also commissioned, we prepare the English manuscript, select the journal, submit, and handle peer review and resubmission.
Typical durations
| Stage | Typical duration | Notes |
|---|---|---|
| Consultation and proposed design | 3 – 7 business days | No charge |
| Protocol and SAP finalised | 3 – 5 weeks | Depends on the completeness of prior data |
| IRB review | 4 – 8 weeks | Subject to the board's meeting schedule |
| Recruitment and conduct | 3 – 12 months | Varies widely with design, sample size and dosing period |
| Analysis and study report | 4 – 8 weeks | From database lock |
| Manuscript and submission | 8 – 16 weeks | Review time depends on the journal |
These are estimates for a typical case. Recruitment difficulty, seasonal factors and board schedules all cause variation; a project-specific timetable is fixed at contract.
What we ask the sponsor to provide
- Specification and an outline of the manufacturing process for the test material (marker compounds, content, batch information)
- Existing safety data (toxicity studies, history of human consumption, approval status)
- Any cell or animal results already obtained, or prior human data
- Sufficient test material and comparator (placebo) for the whole study period
- The intended deliverable — approval dossier, paper, research report or grant proposal
A consultation is still worthwhile even if this material is not yet available. We will set out with you which data need to be obtained first.