- How do you fit our existing MLR stack (Veeva, Aprimo, Zinc)? Are you a workflow system or a layer?
- A layer, not a workflow system. Juncture is a pre-MLR pre-check and a Share-of-Answer layer that complements your MLR system of record, whether that is Veeva PromoMats or Vault, Aprimo, Zinc or AEM. It does not replace your MLR workflow. Reviewers run an asset through the pre-check, see the findings against the label with each clause cited, and consume those findings in your own system. The accountable MLR decision and the final sign-off stay with your people and your system of record. Today you bring assets by ingesting your claims library and approved modules, ingesting the label and sources, or uploading an asset, and you hand back an audit-ready report you attach to a PromoMats or MLR submission. A live Veeva Vault connector and a DAM or asset-registry pull are on the roadmap, in development and not yet generally available. Because the system of record does not change, switching cost is low.
- What is your 21 CFR Part 11 / GxP and validation approach?
- Juncture is Part 11-supporting decision support, not a validated GxP system of record. It provides the supporting technical controls Part 11 calls for: a time-stamped, tamper-evident audit trail, e-signature sign-off, and role-based access control. It backs the human reviewer rather than replacing them. You validate Juncture for Part 11 use under your own SOPs and run it inside your own quality framework. We say Part 11-supporting on purpose, never Part 11 compliant, validated or certified, because that determination belongs to you. SOC 2 is in progress and on the roadmap, not yet complete.
- How configurable are the off-label rules by region and product?
- The rules are tied to the approved label and are configurable per product and per market, so you can codify your own label interpretations and risk tolerances for each affiliate. Claim extraction is AI-assisted, and the rule evaluation itself is deterministic: every verdict cites the controlling label clause it was measured against, so a finding is traceable rather than a black box. A label change moves the rules with it, and the same label drives both the pre-check on the inside and the answer monitoring on the outside.
- Which AI models do you use, and are our prompts or content used to train shared models?
- Inference runs on Azure OpenAI, GPT-class models, and your content is never used to train models, shared or otherwise. For answer monitoring, Juncture tracks the five assistants HCPs actually use: ChatGPT, Gemini, Perplexity, Google AI Overviews and Claude. Those probes use only public, HCP-style questions, never your proprietary data sent into a model. OpenEvidence is a planned roadmap integration, not an engine monitored today.
- Where is data hosted, and how is our tenant isolated? Is there an EU region?
- Juncture is multi-tenant SaaS on Microsoft Azure with per-tenant data isolation, and an EU region is available for customers who require EU data residency. Identity is SSO via Microsoft Entra with SAML or OIDC, with role-based access control across admin, contributor and viewer. Data is encrypted in transit and at rest, the platform is GDPR compliant, audit logs are kept, retention and deletion are customer-controlled, and a DPA is available.
- Do you handle PHI or PII?
- No PHI or PII is required. Juncture works on promotional content, the approved label, and public HCP-style questions. It does not ingest patient data. The Answer Monitor probes use only public questions, so no proprietary or patient data is sent into a model. This keeps the data footprint small and the security review straightforward.
- What does a pilot look like, and how do you measure impact?
- A pilot is deliberately small: bring one brand, one asset, and a public question set, and we stand it up in weeks. We measure impact on your own data rather than quoting numbers from elsewhere. The signals are the pre-check catch-rate before MLR (issues caught before a reviewer opens the asset), the effect on MLR cycle-time, off-label drift caught in the AI answer, and the change in Share of Answer run over run. You see those measured on your brand during the pilot, not as a generic claim.
- Do you provide quantitative benchmarks?
- Not as published client results, because there are none to quote yet, and we will not invent them or restate competitors numbers as ours. A Share-of-Answer Benchmark built on real data is planned. What we do today is measure impact on your own brand in a pilot: pre-check catch-rate before MLR, MLR cycle-time, off-label drift caught, and Share-of-Answer change run over run. That gives you a defensible number from your own assets rather than a borrowed one.