Win the Safety Work You're Losing — Clinical Safety Enablement for CROs
A specialized, AI-augmented safety practice for cell, gene, and ADC oncology trials — with the sponsor-ready assurance to back it. One page on the three-pillar program: physician-led clinical credentialing, governed AI augmentation of your existing PV workflow, and the assurance dossier that gets a sponsor's QA to yes. Delivered pilot-first, fixed-fee.
Get it →Beyond the Molecule — Why Clinical Trial Design Determines Success in Oncology and Hematology
Across 2025–2026’s highest-profile oncology setbacks, the underlying science was frequently sound. The trial design was not. This whitepaper examines three distinct Phase 2/3 failures — population mismatch, enrollment infeasibility, and endpoint misalignment — and proposes a clinically grounded, AI-augmented framework for patient-first trial design. Draws on the published biomarker-stratification evidence base, disease-specific response assessment standards (RECIST, Lugano, RANO, ELN), and current FDA/EMA AI guidance.
Get it →IHASG Readiness Brief — five safety domains, graded to Level 4
A concise brief on Integrated High-Acuity Safety Governance: the five safety domains we grade, the four readiness levels, and what “inspection-ready” actually means for an AI-assisted oncology safety program.
Get it →AMOIP: The Acute Multi-Organ Instability Phase — clinical reference
An open-access reference on the high-acuity window where advanced-therapy safety is won or lost — why conventional pharmacovigilance wasn't designed to see it, and how to govern it. No sign-up required.
Open PDF →Continuous by Design — FDA's Real-Time Clinical Trials Initiative: History, Industry Response, and a Readiness Framework for Sponsors
A briefing for clinical-stage biotech and pharma leadership on FDA's Real-Time Clinical Trials (RTCT) initiative — the five-decade path to "continuous," what RTCT actually announced, the industry's support and unresolved caution, and AyurDatta's four-pillar Continuous by Design readiness framework with a 90-day action plan.
Get it →AyurDatta's Comment to FDA on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket FDA-2026-N-4390)
Our public comment, submitted June 25, 2026, responding to FDA's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program: every AI-assisted safety output creates a matching obligation for documented, qualified human judgment. Filed with the Division of Dockets Management; publicly available at regulations.gov.
Open PDF →