Life sciences work runs on written procedure: protocols, SOPs, specifications. The expensive mistakes happen when procedure is applied unevenly or when nobody can later show how a call was made. Helixor turns that procedure into versioned packs, runs them where your data already lives, and keeps a receipt for every decision.
These are examples, not a complete list. A decision usually fits when it has written criteria, pulls from several systems, happens often, and someone may later ask why it went the way it did. Pick one to jump to it.
Site coordinators screen candidates against a protocol's inclusion and exclusion criteria using lab results, medication lists, diagnoses and history from the EHR. Protocols run to dozens of criteria, amendments change them mid-study, and screening is mostly done by hand from a PDF.
The protocol's criteria become a pack. Each candidate comes back as eligible for a screening visit, not eligible, or needs investigator review, and the remedy lists which criteria failed. A protocol amendment is a new pack version, so you always know which version of the criteria screened each person. The investigator still confirms eligibility.
{
"candidate_id": "SITE14-0387",
"receipt": "hx_proof_0de7f2b91c4a58e3d6a2b7c1",
"pack": "study_ab123.eligibility amendment-3",
"action": "investigator_review",
"rules": ["INC-07-EGFR-BORDERLINE"],
"input_sha256": "e8a3...40cc",
"remedy": ["repeat eGFR within 14 days"],
"logged_at": "2026-09-28T16:20:05Z"
}Before a batch can be released, QA works through the batch record, deviations, in-process tests, environmental monitoring and the certificate of analysis. Most of that review is confirming that everything is present, signed and inside spec, which leaves less time for the few things that need real judgment.
Helixor checks completeness and consistency before QA opens the file: ready for QA review, hold, or reject candidate. It doesn't release anything. The qualified person does. What changes is that QA starts from a list of exactly what's open, and every check has a receipt tied to the batch number.
Adverse event reports come in from call centers, sales reps, literature and partners, in every format. Each case needs a seriousness and expectedness assessment so it lands on the right reporting clock, and a missed clock is a real regulatory problem.
Helixor applies your intake rules to each case and routes it: expedited, standard periodic, or medical review. Anything that mentions death or a life-threatening event always takes the expedited path. Free-text narratives that are unclear can go to hosted reasoning, which can abstain and hand the case to a safety physician rather than guess.
Trial supply teams decide how many kits of each treatment arm to send to each depot and site. They balance enrollment forecasts, expiry dates, shipping lanes that can hold temperature, import permits and the need to keep blinding intact. Too little and a patient can't be dosed. Too much and expensive drug expires on a shelf.
Expiry rules, lane approvals, permits and blinding rules go into the pack, and the goal is to cover forecast demand with as little waste as possible. The solver produces the resupply plan for each depot and site. Every shipment in the plan is then checked by the decision core and gets a receipt tied to the protocol and the kit lots. The pack holds the hard rules and the goal. The solver searches for the best plan that satisfies every hard rule, working from the same typed state the decision core uses. If no plan can satisfy them all, it tells you so instead of quietly breaking one. The solvers are built for GPUs, and that's where large plans solve fastest. Solvers are in Preview today.
| Decision | What Helixor decides |
|---|---|
| Deviation classification | Classify a deviation as minor, major or critical and open the right workflow. |
| Supplier qualification checks | Confirm audits, quality agreements and certificates are current before a PO is released. |
| Workload | Pattern |
|---|---|
| Sites and plants | In-process or loopback sidecar next to the EDC, MES or LIMS |
| Proprietary or restricted data | Air-gapped, with packs compiled on site |
| Unclear narratives | Hybrid escalation with redacted text only |
Helixor checks procedure. It does not make the release decision, confirm trial eligibility, or assess causality. Those stay with the qualified person, the investigator and the safety physician. Pack versions map cleanly to protocol amendments and SOP revisions, which makes the audit trail easy to follow.
Go deeper on helixor.dev: Industry guide ↗ • Deployment patterns ↗ • Core concepts ↗ • Receipts ↗
Bring a written policy and a handful of past cases. We'll turn it into a pack and run it next to your current process so you can compare.