The Compliant Infrastructure Behind Expanded Access.
When a patient needs access to an investigational therapy outside a clinical trial, BeaconCR turns that urgent request into a documented, single-patient expanded-access workflow — from secure intake to a review-ready FDA Form 3926 package. BeaconCR builds the documentation and infrastructure; the treating physician and sponsor make every clinical and regulatory decision.
The pathway
From an urgent request to a review-ready Form 3926 package
Every step is structured, consent-aware, and documented — so the physician and sponsor receive a clean, defensible record rather than a pile of emails and attachments.
Patient or caregiver intake
A secure, consent-aware intake captures the patient request and the treating physician. Patients and caregivers begin here; physicians can also start an intake directly on a patient’s behalf.
Medical record upload
Supporting clinical records are uploaded through a token-gated, encrypted link — no account required for the patient. Files are stored encrypted at rest.
Physician review
The treating physician reviews eligibility, history, and the clinical rationale, and supplies the regulatory and prescribing details the form requires. Every clinical decision stays with the physician.
Encrypted PHI storage
All protected health information is encrypted at rest (AES-256-GCM), and every create, view, edit, and export is recorded in a tamper-evident, hash-chained audit log.
Editable FDA Form 3926 generation
A pre-filled, editable FDA Form 3926 is generated from the structured record — the physician reviews, edits, and confirms every field before anything is finalized.
Review-ready expanded access package
BeaconCR assembles the Form 3926, the supporting records, and the audit trail into a complete, review-ready expanded-access package for the physician and sponsor to act on.
Where to begin
Patients & caregivers
Start a secure intake and identify your treating physician. BeaconCR routes the request to your physician and prepares the documentation — it does not provide treatment or guarantee access.
Begin patient intakePhysicians
Manage incoming patient referrals, review eligibility, and prepare a single-patient expanded-access submission with an editable, pre-filled Form 3926 and a complete supporting package.
Physician workflowBuilt on security and a documented chain of custody
Expanded-access records are among the most sensitive a practice handles. On BeaconCR they are encrypted at rest, access-controlled by role, and tracked in a tamper-evident, hash-chained audit log — so the record is defensible if anyone ever asks who saw what, and when.
How BeaconCR protects this dataBeaconCR is infrastructure, not a treatment provider. BeaconCR does not diagnose, treat, prescribe, manufacture, supply, ship, or administer any drug, biologic, cell or exosome product, device, or investigational therapy, and does not make medical decisions. Using BeaconCR does not guarantee treatment access, study enrollment, FDA authorization, IRB concurrence, physician approval, or any therapeutic outcome. Responsibility for clinical care, regulatory submissions, and treatment decisions rests with the treating physician and the sponsor.
Turn an access request into a documented workflow.
Begin a secure patient intake, or talk to BeaconCR about standing up an expanded-access workflow for your practice or program.