Emerging
biotech.
For clinical-stage biotechs designing the trial that defines the company. Submission-ready trial design, sized to the team you have.
// Where the work breaks
Three problems
Three problems
a small team can't outrun.
Emerging biotechs do extraordinary work on tight capital and tighter timelines. Each program is essentially one shot at the regulator, and the design decisions on the pivotal trial define the company. Endpoints, eligibility, sample sizing, regulatory positioning; the choices made on the synopsis compound across every quarter that follows.
P / 01
One shot at the regulator's first read.
The design decisions on a pivotal trial; endpoints, eligibility, statistical strategy, regulatory framing; have to land on first contact. There isn't a regulatory-affairs department running scenarios in parallel, and the cost of a do-over is measured in quarters of runway.
$10M+ Cost of a 6-month regulatory hold · burn + program delay
P / 02
Bring your own design to the table.
The trial-design IP; endpoints, eligibility logic, statistical approach; belongs to the sponsor. CRO partners execute on top of it brilliantly, but the strategic choices are yours to own; arriving with a working design, not a default template, changes the conversation.
1 Typical in-house medical writer · Series A–B biotechs
P / 03
Every amendment is a quarter of runway.
A design flaw caught after first patient; an endpoint that won't power, an eligibility criterion that strangles enrollment; isn't an expensive nuisance, it's six months of runway. A Series B company can come off the road on a single amendment.
$1.8M Avg. monthly burn · Phase 2 biotech
// What changes
We change that, by stress-testing endpoints, eligibility, and statistical strategy against the corpus and the regulator from synopsis onward, not after first patient. By giving the team a trial design they own before the conversation with partners begins. And by keeping the runway you would have spent on amendments in the bank, not on rework.
// Target outcomes
What a pivotal-trial engagement is sized to deliver.
Sized against a clinical-stage biotech program running its first Phase 2 or pivotal trial. Four metrics across cycle time, spend, financing position, and time to first patient dosed. Baselines are program-specific.
60%
Trial-design cycle time
Synopsis → submission-ready · vs. industry average
$320k
Avoided medical-writing spend
Per Phase 2 trial · vs. typical vendor contract
+9 wks
Ahead of next financing milestone
vs. prior internal plan · across deployed cohorts
8 wks
Time saved to first patient dosed
vs. unit baseline · across deployed cohorts