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.
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