What we help with
Across 2025–2026's highest-profile oncology setbacks, the underlying science was frequently sound. The execution decisions were not. These are the four we help you get right the first time.
Protocol & trial design
Population, endpoints, enrollment feasibility — the three places sound science dies in Phase 2/3. Clinically grounded, AI-augmented design review before you commit the program.
Read our whitepaper on why trial design decides success →Regulatory strategy & submissions
Pre-IND through filing, with CMC alignment early — roughly a quarter of clinical holds trace to avoidable CMC and quality gaps. A unified narrative across modules, built by people who have carried filings through.
Safety from day one
Right-sized safety governance that stands up to your first SAE wave, partner diligence, and inspection — without buying a big-pharma PV department.
See the IHASG model →AI, adopted responsibly
Use AI where it genuinely accelerates — and carry the governance, validation, and human sign-off that keeps it defensible to regulators, partners, and investors.
Explore expert-in-the-loop →How we engage
Program assessment
A bounded, fixed-fee review of your program — design, regulatory path, safety setup, AI exposure — with a prioritized roadmap you own outright.
Weeks · fixed fee
Build the foundations
The protocol, the briefing package, the signal criteria, the governance design — each a bounded deliverable, each usable whoever executes next.
Per deliverable · fixed fee
Senior oversight as you run
Ongoing medical, regulatory, and technology counsel scaled to program activity — the experienced pair of hands beside your lean team.
Ongoing · retainer
A steady, experienced pair of hands — not a transactional vendor
Two principals lead every engagement: one from clinical development, pharmacovigilance, and regulatory strategy; one from platform architecture and applied AI inside FDA-regulated environments. You get both altitudes — board-level judgment and the hands-on depth underneath it — without hiring either.
- › 27 INDs, 9 NDAs, 3 BLAs of direct filing experience
- › The unified eClinical platform behind 1,000+ trials
- › Oncology, hematology, and rare disease depth
- › Every deliverable stays with you, whoever advises you next
"A single enrollment setback, protocol amendment, or regulatory challenge can decide a program's viability."
The emerging-biotech reality — and the reason the first move has to be right.
Twenty minutes. Bring the hardest question your program faces.
If we can help, we'll tell you how — scoped, bounded, fixed-fee. If we can't, we'll tell you that too.
Book an intro call