The work is moving to AI.
The accountability isn't.
Every AI-accelerated protocol, signal, and submission still needs a qualified human who decides — and proof that they did.
AyurDatta is that layer: physician-led safety governance for sponsors, modernization
and
credentialing for CROs and FSPs, and named, credentialed experts wherever AI output must stand
up to a regulator, a partner, or a buyer.
Built for the people accountable when AI meets the clinic
Biotech & Pharma
Safety governance, development support, and AI you can defend to an inspector — for teams whose next milestone can't absorb a wrong move.
Explore sponsor solutions →CROs & FSP Providers
Modernize your operations, credential your teams, and put sponsor-facing capability under your own brand — without an enterprise budget.
See CRO & FSP enablement →Expert-in-the-Loop
Named, credentialed experts who review, validate, and sign — the human-in-the-loop layer regulators require and buyers trust.
Explore expert-in-the-loop →Three forces arrived at once
Regulators went real-time, AI outran its own governance, and the people who can run both became the scarcest asset in the industry. Whichever seat you sit in, the same clock is ticking.
Regulators went real-time
The FDA's Real-Time Clinical Trials initiative moves the industry from periodic data batches to continuous signal flow — live from the trial to the agency.
AI outran its governance
AI spread through clinical work faster than the validation, oversight, and sign-off design around it — which is why most pilots stall before production, not at the model.
Judgment doesn't compress
Regulated decisions still require a qualified human — and proof that one made the call. That is the obligation we are built to carry, in every engagement.
Safety governance — where the stakes are highest, and where we started
AI now detects and grades safety signals at machine speed — but a flag is not a decision. A named, credentialed physician must adjudicate benefit-risk, and you must be able to prove they did. Integrated High-Acuity Safety Governance (IHASG) closes that gap, running on our Medical Oversight Workbench:
- › A named, credentialed oncologist as your documented reviewer
- › Part 11-style sign-off — identity, time, and meaning locked in
- › A tamper-evident audit trail, generated as the work happens
- › Sits beside your stack — not a rip-and-replace
"Show me the documented physician review for these fourteen AI-flagged signals."
The inspection question every AI-assisted safety program must answer — with a name, credentials, and an audit trail.
The judgment is the product
Unlike a CRO, we don't execute your trial — so we can impartially oversee it. Unlike a software vendor, we don't audit our own algorithm. Independence is not our limitation; it is the product — delivered by named principals, not staffed down.
Specialist depth where the toxicity is hardest
Capabilities
Safety governance is the spearhead. Behind it is the full clinical, regulatory, and technology depth to execute the entire program.
Safety & PV Operations
Case processing, QPPV/LPPV, signal management, PSUR/DSUR, and ICSR submissions — the execution muscle beneath IHASG.
Explore →Clinical Development
FIH and dose-escalation through pivotal Phase 3 and post-marketing — built for oncology, hematology, and rare disease.
Explore →Regulatory Strategy
Fast Track, Breakthrough, and Accelerated Approval pathways — 27 INDs, 9 NDAs, 3 BLAs of direct experience.
Explore →AI & Analytics
Real-time data integrity, predictive enrollment and site analytics, and safety signal detection across multi-modal data.
Explore →Medical Expert Network
A Program Readiness Board (PRB) of global oncology KOLs — evaluating your program across clinical, regulatory, safety, and technology readiness.
Explore →Full Service Catalog
The complete menu of clinical, regulatory, safety, and technology services available to support your program.
Explore →Three steps — and you own everything we produce
A fixed-fee assessment
Your program, your operation, or your AI exposure — honestly mapped, with a graded roadmap you own outright. Valuable whoever executes it.
3–4 weeks · fixed fee
A bounded first deliverable
A signal framework, a protocol review, a governed AI pilot, a credentialed pod — one fixed scope, one measured outcome, before anything scales.
Fixed scope · fixed fee
Senior oversight, ongoing
Named reviewers, embedded counsel, or an enablement retainer — running alongside your work, scaled to activity, documented by default.
Ongoing · retainer
Prefer embedded leadership? Our principals are also available on a fractional basis. See all engagement models →
Delivered by the named principals
Dr. Ashok Srivastava
MD, Ph.D., MBAPresident & Chief Medical Officer
Board-certified oncologist and the named physician reviewer. 135 trials, 11 first-in-human, 27 INDs, 9 NDAs, 3 BLAs including AUCATZYL® (obe-cel) CD19 CAR-T. Deep CAR-T, ADC, and rare-disease toxicity expertise; DSMB/IDMC Chair for novel-modality programs.
Elias Tharakan
Chief Executive & Technology Officer
Architect of the industry's first unified EDC + RTSM + eCOA + Safety suite, powering 1,000+ trials across 90+ countries. Clinical technology strategy, AI governance, and GxP-validated delivery at industry scale — the engineer behind the Workbench and the unified platform to come.
Bring us the hardest question your program faces.
Twenty minutes to scope the right first step — bounded, fixed-fee, and yours to keep. If we're not the right fit, we'll tell you that too.