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Latest articles
Short summaries and downloadable white papers below. Click any card to read the full article.
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.
How to Implement AI Without Violating FDA 21 CFR Part 11
A compliant framework for adopting AI in clinical safety while keeping identity, signature, and audit trail intact under 21 CFR Part 11.
Inside the First Unified eClinical SaaS Platform
The story behind building the industry's first unified EDC + RTSM + eCOA + Safety platform — and why the unified decision record matters now.
Unified eClinical Platform vs Best-of-Breed: The Real Tradeoffs
A practical comparison of unified platforms versus best-of-breed tools for clinical trial technology.
The 7 Most Expensive eClinical Technology Mistakes Biotechs Make
Common technology mistakes that cost biotechs 12-18 months and significant budget in clinical trial delays.
RTSM vs IRT: What's Changed in Randomization Technology
Understanding the evolution of randomization technology and what it means for modern trials.
Navigating the Critical Path: The Art and Science of Medical Monitoring in Oncology
The art and science of medical monitoring in oncology trials — and how proactive oversight protects both patients and timelines.
The Vigilant Vanguard: Proactive Medical Monitoring
Proactive strategies for medical monitoring and risk-based oversight.
Medical Monitoring
Best practices and strategies for medical monitoring in clinical trials.
Our Value
How AyurDatta delivers value across safety governance, clinical operations, and regulatory strategy.
In the news
Press releases and media coverage about AyurDatta.
AyurDatta introduces IHASG and the Medical Oversight Workbench
AyurDatta formalizes Integrated High-Acuity Safety Governance (IHASG) and unveils the Medical Oversight Workbench — physician-in-the-loop safety oversight for the RTCT era.
AyurDatta attending 2025 Philly Momentum: In Vivo CAR-T & IIT Pathways
AyurDatta will attend Philly Momentum to engage with leaders in In Vivo CAR-T and IIT pathways.
Industry Veterans Dr. Ashok Srivastava and Elias Tharakan Launch AyurDatta
AyurDatta launches to bridge clinical science and AI-powered execution for biopharma innovators.