Step 2: Clinical review.

Clinical review is the second stage of a case, and it is the stage that determines whether the therapy the prescriber has in mind is the right therapy for the specific patient, given the current label, the current evidence, and the facts of the case. This is the pharmacy-level review that any US specialty pharmacy would perform on the same prescription, and it is designed to catch issues that are better caught before a shipment is in motion than after.

What clinical review checks

The AI Clinical Review Agent runs a structured check on four axes. The first is label consistency: the drug, indication, dose, schedule, and duration written in the prescription are compared against the current FDA label, and any element that falls outside the label is flagged for rationale. The second is evidence context: the Agent reviews the current body of published evidence for the indication and flags cases where a more recent treatment paradigm or an updated guideline might be relevant to the prescriber's plan. The third is patient fit: the Agent reviews the patient-specific information in the record for contraindications, notable drug-drug interactions, organ-function considerations, and any previously documented adverse reactions relevant to the proposed therapy. The fourth is practical administrability: for therapies requiring specific infusion infrastructure, monitoring, or companion diagnostics, the Agent confirms that the receiving environment can support the administration.

What documents are reviewed

Clinical review is built on the materials supplied by the prescriber and the family. The core set includes the written prescription, the medical-necessity letter, and the clinically-relevant subset of the patient's history for the indication in question. Where the prescriber has ordered companion diagnostics, we expect those results; where the patient has undergone prior treatment for the same indication, we expect the outcome summary; where the prescriber is working from a specific guideline or a tumor-board recommendation, we expect the reference. We do not ask for the full medical record, because full records are both privacy-heavy and rarely useful at our review level. We ask specifically for what the review needs.

The AI Clinical Review Agent and physician handoff

The AI Clinical Review Agent is a reviewer, not a decider. Its outputs are structured, legible, and auditable, and they are reviewed by a human US-licensed pharmacist before any clinical eligibility determination is finalized. Where the pharmacist sees something the Agent flagged that warrants a clinician's judgment, or where the case is inherently nuanced in a way that benefits from a physician's review, the case escalates to a physician on our advisory panel for further review. Physician review is typical in complex oncology cases, in pediatric cases, and in rare-disease cases where the standard-of-care is still evolving. At every level, the decision-maker is named in the case record; the AI Agent supports the review but does not own the outcome.

Eligibility determination

Clinical review closes with an eligibility determination that takes one of three forms. A clean eligibility determination means the therapy choice and the case-specific facts support proceeding, and the case moves to regulatory review. A conditional eligibility determination means the review is positive pending a specific clarification or additional document from the prescriber; we describe precisely what we need and hold the case open. A non-eligibility determination means clinical review has identified an issue that we judge structural enough to decline on, and we return the case to the family and prescriber with a written explanation of the concern and, where possible, a referral.

Time, privacy, and documentation

A typical clinical review is completed within three to five business days from the point all requested documents are in hand. Complex cases requiring physician panel review may run longer, and we communicate the expected window when we request the additional review. All clinical review materials are handled under HIPAA and, where the patient has an EU nexus, under GDPR; materials are retained only for the period regulatory obligations require, and they are not shared outside the review team. The case record is made available to the prescriber on request at any point in the process.

Handoff to regulatory review

Once clinical eligibility is established, the case moves to regulatory review, where the named-patient pathway at the destination country is assessed and the regulatory documentation package is prepared. Clinical and regulatory review often run in parallel when the case is time-sensitive; when they do, the outputs are reconciled before the case clears into sourcing.

Reviewed 2026-04-22 by Reserve Meds’s AI clinical and regulatory review agents. Human pharmacist-in-charge: Altima Care. Next scheduled review: 2026-10-22.