Clinical development & operationsEarly-stage oncology
Oncology clinical development, run by operators who have reached approval.
Mindrise Medica is a senior, hands-on practice for early-stage oncology biotech. We take a program from IND strategy through first-in-human and toward FDA approval — working directly with your team, not around it.
Padcev Keytruda
15+ years1,000+ trial sitesPhase I → FDA
Proven, not promised.
The case for Mindrise is a record, not a pitch. Real programs, real numbers, real approvals — the work behind two oncology drugs now reaching patients.
- 15+years
- Leading global oncology programs, Phase I to FDA approval
- 1,000+sites
- Clinical trial sites managed in lean-team settings
- 2approvals
- Named oncology programs carried to FDA approval
- I–IVphases
- End-to-end execution, from first-in-human onward
One rail, end to end.
Most partners own a slice of the journey. We have run the whole length of it — and the programs that prove it reached the only stop that matters.
- INDStrategy & enabling
- Phase IFirst-in-human
- Phase IIDose & signal
- Phase IIIRegistrational
- ApprovalFDA approval
What we run
Four areas where senior, hands-on execution changes the outcome of an early oncology program.
IND & Early Clinical Strategy
Translate the science into a regulatory and clinical path that survives contact with the FDA — IND-enabling strategy, first-in-human design, and the dose-finding plan that earns your next round.
IND strategy · FIH protocol · regulatory interactions
Clinical Trial Operations
The day-to-day machinery of a running oncology trial, owned by senior operators: site selection and activation, vendor oversight, enrollment, data quality, and timeline discipline.
Site activation · vendor oversight · enrollment · data quality
Trial Rescue & Turnaround
When a program is behind, over budget, or off-protocol, we step in and stabilize it — diagnosing the failure, resetting operations, and getting enrollment and data back on a credible track.
Diagnosis · operational reset · enrollment recovery
Inspection & Audit Readiness
Build the program so an FDA inspection is a formality, not a crisis: GCP-aligned documentation, audit-ready sites, and the inspection preparation that protects a registrational dataset.
GCP compliance · site audits · inspection prep
Your hardest decision, in steady hands.
Handing the clinical execution of your lead program to an outside team is the most consequential call a founder makes. We are built to make that decision feel de-risked — not by promising, but by having already done it.
- Senior people, in the room
- The people who scope your program are the people who run it. No hand-off to a junior bench, no account layer between you and the work.
- Boutique by design
- We take on a limited number of programs so each one gets genuine attention. You work with a lean, elite team directly — never a faceless vendor.
- Evidence over adjectives
- We have taken oncology programs from first-in-human to approval. That track record does the persuading; we would rather show the work than describe it.
Let's talk about the program you're about to run.
We take on a limited number of oncology programs each year. If you are moving toward IND, first-in-human, or a trial that needs rescuing, we should talk.