Public
sector.
For academic medical centers, government research bodies, and publicly-funded consortia. Investigator-grade rigor, regulator-grade defensibility.
// Where the work breaks
Three problems
Three problems
industry doesn't see.
Investigator-initiated and publicly-funded trials carry some of the most important questions in clinical research. They run on grant cycles, lean teams, and infrastructure that's typically shared across many studies at once. The pains below repeat across academic and government research environments, regardless of the regulator on the cover page.
P / 01
// Investigator-initiated · Award → Approval
Trial design carries the workload nobody sees.
Most of the work. Endpoints, sample, regulatory precedent, enrollable population. Happens before a single page is drafted, on capacity shared across the portfolio.
~6 mo Median time · grant award → approval-ready protocol
P / 02
// Investigator-initiated · Sponsor obligations
The investigator is also the regulatory sponsor.
When a study tests a new use of an existing therapy, the institution carries the same GCP obligations as an industry sponsor. The bar doesn't adjust for team size.
< 1 Dedicated regulatory-affairs FTE in the median academic trial unit
P / 03
// Investigator-initiated · Grant cycle
Funders measure the milestones.
Public funders expect protocols that meet the same regulatory bar as industry trials. A design issue surfaced in year one is grant time the renewal window won't reopen.
~85% Publicly-funded RCTs that miss planned enrollment on schedule
// What changes
We change that, by stress-testing the trial design against the corpus and the regulator before the protocol is written, not after. By carrying the sponsor obligations that come with publicly-funded research on the platform, not on the PI's calendar. And by surfacing enrollment risk during design, not at the year-end progress report.
// Target outcomes
What a twelve-month deployment is sized to deliver.
Sized against a mid-sized academic trial unit running ~12 investigator-initiated and cooperative-group protocols a year. Baselines are unit-specific. The pattern is consistent regardless of funder or regulator.
4 mo
Time saved · grant award → approval-ready protocol
Median · vs. unit baseline · across deployed cohorts
60%
Ethics / IRB first-round queries per protocol
From ~10 → ~4 queries · pooled across TA cohorts
100%
Protocols indexed in the institutional hub
Twelve-month enrollment of legacy archive
0
Regulatory holds across the unit
vs. 2 in the prior 24-month baseline · across regulators