The brief
“We're building a trial-operations platform for sponsors and CROs. Multi-tenant by design, regulatory-grade audit trail, and AI-native at the core. We want every surface — the trial data layer, the protocol + regulatory knowledge layer, the autonomous monitoring agents, the in-product analyst copilot, the sponsor-facing dashboard — built coherent, in one engagement, by one architecture team. We'd rather get the foundation right once than retrofit AI onto a non-AI codebase a year from now.”
The shape we'd build
A complete reference-architecture deployment tuned to clinical trial operations. Multi-tenant trial data with encryption at rest, per-sponsor cost protection, and an audit trail engineered against the regulatory bar. A knowledge layer holding protocols, regulatory guidance, prior amendments, and historical query/answer history — queried through one API by humans, by monitoring agents, and by the sponsor-facing analytics surface.
Autonomous monitoring agents that watch trial event streams, surface anomalies, and file findings into the existing review queue. An in-product copilot for the operations team that drafts protocol-deviation reports and amendment correspondence. A customer-facing sponsor dashboard with brand-aligned voice and per-tenant rollout flags. Every layer built coherent — the knowledge layer the agents query is the same one the dashboard reads from; per-tenant cost protection is enforced once at the runtime layer, not bolted onto each feature.
What the platform owns when we step back
A complete AI-native platform that scales without re-architecting. Every layer is documented, evaluable, observable, and operable by the platform's engineering team — code in their repo, infra in their cloud, dashboards in their environment, runbooks for every surface. The architecture is the foundation; the features are the proof points. When the team wants to add a new agent role or a new sponsor-facing feature a year from now, the substrate to do it is already there.