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 five 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 →CRO & vendor oversight under ICH E6(R3)
The revised ICH E6(R3) puts sponsor oversight of delegated activities squarely back on you. We provide the independent, credentialed oversight layer that keeps CRO and vendor performance defensible — without duplicating their work.
See how we work alongside your CRO →Your modality, your experts
Novel-modality toxicity doesn't read from a generic playbook — CRS grading, ADC organ toxicity, and radioligand dosimetry each demand a specialist who has lived it.
How to start
Executive briefing
Novel-modality safety, FDA pathways, and AI expectations — for your board and leadership team.
Readiness Board or red-team
A Program Readiness Board review or an IND/BLA red-team — a graded, bounded assessment with a roadmap you own.
Embedded delivery
Protocol and signal definitions, fractional CMO/CTO, or Continuous Medical Oversight — running alongside your team.
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, including a CD19 CAR-T (AUCATZYL®)
- › 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 reality at every stage — and the reason the first move has to be right.
Not a separate workstream — inside the moments that matter
Questions sponsors ask us
How is this different from a CRO?
A CRO executes your trial. We provide the independent clinical, regulatory, and technology judgment that oversees the program — including, when useful, oversight of your CRO's own delivery.
Can you work alongside our existing CRO?
Yes — that's the common case. We complement CRO execution with named physician and technology oversight, not a competing delivery team.
Who actually does the work?
A named AyurDatta principal owns the engagement. Delivery comes from that principal, our credentialed expert network, or a vetted partner — always disclosed, never anonymous.
What do we own at the end?
Every deliverable — the protocol, the assessment, the roadmap, the documentation — is yours outright, usable whoever advises or executes next.
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 a program readiness conversation