Five lines of inquiry
Our editorial focus follows the same thesis as our work: where AI-speed safety data meets the human, documented judgment regulators require.
Advanced Oncology Safety
CAR-T (CRS/ICANS), ADC organ toxicity, radioligand dosimetry, and the AMOIP window — why advanced therapeutics break legacy pharmacovigilance.
RegulatoryRTCT & Regulatory
The FDA's Real-Time Clinical Trials initiative, inspection expectations for AI-assisted safety, and what regulators are signalling in plain language.
TechnologyCompliant AI & Platform
Physician-in-the-loop architecture, 21 CFR Part 11 in the age of AI, and the road to a unified, compliant safety platform.
OperationsClinical Operations
Medical monitoring, ICU-aligned safety governance, and proactive oversight across pediatric, adult, and elderly populations.
PlatformeClinical Technology
Lessons from building the industry's first unified EDC + RTSM + eCOA + Safety platform across 1,000+ trials.
EverythingAll articles & news
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The assumption baked into every pharmacovigilance system — and why it fails CAR-T patients
Conventional pharmacovigilance was built for drugs that reveal their toxicity slowly. CAR-T does the opposite — and the mismatch is a patient-safety problem, not a paperwork problem.
CAR-T toxicity 101: what every sponsor safety team needs before the first patient is dosed
A working orientation to CRS and ICANS for safety and clinical development teams — what to define before enrollment, not after the first event.
The Acute Multi-Organ Instability Phase (AMOIP): a clinical reference
There is a clinical window in advanced-therapy toxicity that conventional pharmacovigilance was not designed to see. We call it AMOIP — and naming it changes how you govern it.
Latest insights
The assumption baked into every pharmacovigilance system — and why it fails CAR-T patients
Conventional pharmacovigilance was built for drugs that reveal their toxicity slowly. CAR-T does the opposite — and the mismatch is a patient-safety problem, not a paperwork problem.
CAR-T toxicity 101: what every sponsor safety team needs before the first patient is dosed
A working orientation to CRS and ICANS for safety and clinical development teams — what to define before enrollment, not after the first event.
ADCs are not chemotherapy: a clinical briefing on organ-specific toxicity
Antibody-drug conjugates carry a targeted-toxicity profile that conventional chemotherapy monitoring is poorly shaped to catch. Treating them alike is a clinical safety error.
RLT safety monitoring: marrow reserve, renal function, and the dosimetry gap
Radioligand therapy carries a safety problem most pharmacovigilance teams are not trained to see — one that lives in cumulative dose, marrow reserve, and renal clearance.
The Acute Multi-Organ Instability Phase (AMOIP): a clinical reference
There is a clinical window in advanced-therapy toxicity that conventional pharmacovigilance was not designed to see. We call it AMOIP — and naming it changes how you govern it.
Regulatory expectations for advanced oncology safety in the RTCT era
FDA, EMA, and ICH are not writing about AI-assisted, real-time safety in plain language. Here is the translation — and what it means for your program now.
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The AyurDatta Academy
Learn medical monitoring and AI-assisted safety oversight the way the real-time era of clinical trials demands — the IHASG approach, from the people defining the standard.
Send me training info →Governing Safety in the RTCT Era: From AI Flag to Defensible Decision
A working session for sponsor safety and clinical-development teams on what the FDA’s Real-Time Clinical Trials initiative and AI-driven pharmacovigilance actually demand — and how to make physician judgment fast, documented, and inspection-ready.
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