Research into two-party agentic delivery
Clinical development, drug sponsors, CROs, pharmacovigilance, and regulated life-sciences manufacturing.
AAO-091 / Regulation and Compliance
Life-sciences executives should require a documented impact assessment when a supplier changes an AI-supported regulated workflow. Prior validation supports the tested use and configuration; it should not be presumed to cover every later model, tool, process, or human-review change.
AAO-088 / Regulation and Compliance
Life-sciences boards should require a clear operating chain from receipt of potential safety information to qualified assessment, required reporting, and reconciliation. AI-enabled outsourcing should not obscure awareness, case ownership, deadlines, or the human work needed to meet the safety obligation.
AAO-077 / Assurance and Audit
Clinical outsourcing managers should make human corrections to AI-supported work attributable, justified, and linked to the original record. Quality review should improve the evidence while preserving the history needed to assess trial reliability.
AAO-076 / Regulation and Compliance
Drug sponsors should retain the ability to substantiate evidence produced through AI-enabled suppliers. Outsourcing trial activities does not transfer the sponsor’s ultimate responsibility for participant protection and reliable trial data under the applicable clinical-trial framework.
AAO-037 / Delivery and Operations
Pharmacovigilance managers should preserve the relevant initial receipt and awareness evidence across every supplier handoff. An internal transfer or agent-processing event must not silently replace the event that starts the applicable safety-reporting clock.