Your AI flags the signal.
Who makes the call — and can you prove it?
AI tools now detect and grade safety signals fast. But the decision is still yours: a named, credentialed physician must review it, and you must be able to prove they did. That is Integrated High-Acuity Safety Governance — built for today's AI-assisted trials, and for the FDA's Real-Time Clinical Trials era ahead.
Clinical safety just got a new clock
Two shifts arrived at once — and together they compress every safety obligation you carry: signals defined before the trial, adjudicated as they fire, documented to an inspection-ready standard, at the speed your data now moves.
RTCT launched
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.
A new obligation
AI has spread through pharmacovigilance faster than the governance around it — and every algorithmic flag creates a matching human-oversight obligation that software cannot fulfill.
Judgment doesn't compress
Benefit-risk judgment still requires a qualified physician — and proof that one made the call. That is the obligation we are built to carry.
Algorithms stop at the flag. Your obligation doesn't.
AI-PV platforms now detect, score, and draft competently. But a flag is not a decision. The regulatory obligation runs further: a qualified physician must adjudicate benefit-risk, and the review must leave a documented trail — who reviewed, when, under what criteria, with what outcome. Most clinical-stage companies deploying AI in safety today cannot name that reviewer or produce that trail.
- › The first SAE wave after enrollment opens
- › Partner or investor diligence on your safety setup
- › A PSUR cycle with an undersized team
- › The inspection that asks the question on the right
"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.
Integrated High-Acuity Safety Governance
IHASG connects AI-speed signal detection to documented, physician-owned decisions — inspection-ready as the work happens. Four ways in, one standard of judgment.
Readiness Assessment
A fixed-fee, 3–4 week diagnostic of your safety governance, systems, and AI exposure — with a graded gap analysis and remediation roadmap you own outright.
Signal Definition & Pre-IND
Clinically rigorous signal criteria for your program — CRS, ICANS, DLTs — mapped to data elements and ready for regulator alignment.
Continuous Medical Oversight
A named, credentialed oncologist as your documented safety reviewer — adjudication, expedited sign-off, and SRC/DSMB support, every decision audit-ready.
Inspection & Governance Readiness
Mock-inspection review of your AI oversight documentation and SOPs — so the inspection question has an answer before it is asked.
From flag to defensible decision in five steps
Signal arrives
AI-flagged event lands in the review queue with full source data.
➤AI assembles
Draft narrative and suggested grade in seconds — labeled suggested.
➤Physician decides
Named reviewer adjudicates — can override, documents rationale.
➤Sign-off binds
Part 11-style e-signature: identity, time, and meaning locked in.
➤Trail exists
Tamper-evident audit record, generated as the work happens.
The architectural invariant: no AI output becomes a record of decision without a physician's review and signature. We built the bypass out — because the regulatory obligation is human.
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
Readiness Assessment
Bounded, fixed-fee, 3–4 weeks. A graded gap analysis and remediation roadmap you own outright — valuable whoever executes it.
3–4 weeks · fixed fee
Signal Definition
Your program's clinical risk profile translated into regulator-ready signal criteria and data mapping — the foundation continuous oversight is built on.
Per program · fixed fee
Continuous Oversight
A named physician reviewer, the Workbench, and a documented decision trail running alongside your trial — scaled to program activity.
Ongoing · monthly 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.
Let's make sure you have the answer first.
Start with the Readiness Assessment: 3–4 weeks, fixed fee, a graded roadmap you own — scoped on one call.