Where an IIT fits
An IIT is sponsored by the investigator and their institution, not by you. That is what makes
it fast: it moves on institutional review rather than a full regulatory submission, and the
sites that run them do so continuously. It is also what makes scoping matter. You are not
running the study, you are supporting one, and the value you get out depends entirely on how
well the question, the site, and the data terms are set up before it starts.
The right moment is usually after preclinical data is convincing but before a full global
development path is funded — when what you need is a real human read on activity, dose or
combination, and you need it before the next raise or partnering conversation.
A good fit when
- Safety and manufacturing are far enough along to dose patients
- The indication has a treatable population at Chinese centers
- The question is activity, dose, or combination rather than registration
- An early read changes what you fund next
A poor fit when
- You need data that will support a US or EU filing on its own
- The asset is not yet ready for human administration
- The population is vanishingly rare in China
- You cannot commit to supplying investigational product
An IIT produces exploratory evidence. It does not substitute for a registrational trial, and
we will say so early if what you actually need is a sponsor-run study.
Where the studies run
Chinese trial capacity is concentrated in a relatively small number of academic centers, and the ones that matter for a given indication are fewer still. Our network is built around the institutions and investigators who run early-phase work continuously.
- 18
- cities with major early-phase capacity
- 6
- hubs where most oncology and cell therapy work concentrates
Site selection is indication-led, not geography-led. The right center is the one that treats your population in volume and has run studies like yours before. We shortlist against that, then diligence the operating team behind the name.
Cities shown are the principal centers of early-phase clinical research in China. Specific institutions are named during feasibility, once the indication is known.
How the work runs
Six phases. You approve at the end of each one before the next begins.
Phase 1
Feasibility
Is this study worth running here
Before anyone is contacted, we test whether the question can actually be answered in China at the scale and speed you need.
- Population check — incidence, standard of care, and how treatment-naive the relevant patients are
- Competitive landscape — what else is enrolling against the same population
- Regulatory read — whether the design holds as an IIT or needs a sponsored route
- Supply reality — how investigational product reaches the site, and who imports it
- Data feasibility — whether the data and samples you need can leave China under Human Genetic Resources rules
Phase 2
Selection
Finding the investigator and the institution
The single largest determinant of whether an IIT produces usable data is who runs it. We diligence the operating team, not just the name on the paper.
- Investigator shortlist — prior work in the indication, enrollment history, publication record
- Site diligence — GCP track record, trial volume, pharmacy and lab capability, monitoring history
- Operating team review — the study coordinator and data manager who will actually run it day to day
- Capacity check — what else that team is running, and where yours would sit in their queue
- Introduction and alignment — we make the introduction and stay in the room
Phase 3
Protocol
Aligning the science before the paperwork
The investigator owns the protocol. Your job is to make sure it answers your question, and ours is to make sure that conversation happens before submission rather than after.
- Endpoint alignment — what readout would actually change your decision
- Assessment schedule — the sampling and imaging that produce it
- Biomarker and sample plan — what gets collected, stored, and analysed where
- Statistical framing — what the study can and cannot support at its size
- Safety reporting — how events reach you, and how fast
Phase 4
Approvals
Ethics, registration and the data pathway
This is where timelines are usually lost, and where local familiarity is worth the most.
- Ethics committee submission — prepared and tracked through the institution's cycle
- Trial registration — on the appropriate registry
- Human Genetic Resources — approval scoped and filed where samples or genetic data will be exported, which sits on the critical path more often than sponsors expect
- Import pathway — permits and the licensed importer of record for investigational product
- Agreements — the study agreement, data rights, publication terms, and IP
Phase 5
Execution
Keeping it moving, and telling you the truth about it
You do not manage the site. We do, and you hear about problems while they are still fixable.
- Startup and activation — site initiation, training, first patient in
- Enrollment tracking — actual against planned, with the reason when it slips
- Protocol deviations — surfaced as they happen rather than at database lock
- Data quality review — periodic checks against the agreed acceptance criteria
- Sponsor updates — a standing cadence in your timezone, in English
Phase 6
Readout
Getting the data out and into your hands
An early signal is only useful if you can act on it and show it to other people.
- Data transfer — executed under the terms agreed in Phase 4
- Source verification — a defined review against source records
- Independent read — where the endpoint warrants it
- Interpretation — what the result supports, and equally what it does not
- Next step — how the data feeds a Western filing, a partnering conversation, or a decision to stop
What you send, and what we hand back
To start a conversation
- The development question you need answered
- Whatever exists of a protocol concept, even a paragraph
- Asset stage: preclinical package, safety data, manufacturing readiness
- Your timing, and what decision the data feeds
What comes back
- A feasibility read with a clear recommendation, including not to proceed
- A shortlist of investigators and institutions with the diligence behind each
- A scoped plan with timeline, milestones, and a fixed advisory fee
- Through execution: one accountable point of contact and no vendor to manage
Engagements are scoped per study. Feasibility is the usual starting point and is deliberately
bounded, so you can find out whether this is worth doing without committing to the study.