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.
What a generated Form 3926 looks like
The example below shows the structure of a Form 3926 produced from a completed intake — every field the physician reviews before filing. The sample is fully de-identified: the names, dates, and identifiers are placeholders, not a real request.
FDA FORM 3926 — INDIVIDUAL PATIENT EXPANDED ACCESS INVESTATIONAL NEW DRUG APPLICATION (SAMPLE)
De-identified example — all fields shown are placeholders
Patient information
Name: [Patient Full Name] · Date of birth: [MM/DD/YYYY] · Address, phone on file with the treating physician
Treating physician
Name: [Physician Name, MD] · License: [State/Number] · Facility: [Institution, Address] · Contact on record
Investigational drug
Drug name: [Investigational Product] · Manufacturer/sponsor: [Sponsor of Record] · IND status: [Existing IND # / Emergency IND requested]
Treatment description
Dose, route, and duration: [per protocol entry] · Administration setting: [clinical setting description]
Clinical rationale
Prognosis, prior treatments, and why the investigational drug may be beneficial: [summary drawn from the structured intake and uploaded records]
Clinical status
Moderate to severe description per the intake assessment; supporting labs and imaging references listed from uploads
Risk acknowledgment
Known risks summarized; patient informed of risks and alternatives; IRAE/consent documentation referenced
Physician certification
Physician statement that the patient meets the expanded-access criteria, signed and dated at filing
This sample illustrates the platform’s generated form structure. The live workflow produces a complete, editable form from the structured intake — the physician reviews and confirms every field before anything is filed.
The intake workflow, end to end
Every request moves through the same tokenized path. The screens below are wireframe mockups of the live flow — representative layout, not a real patient’s session.
Patient intake
Secure form captures diagnosis, treating physician, and therapy interest. No account needed.
Physician referral
The treating physician receives a tokenized link to confirm eligibility and clinical details.
Verification
Identity and role checks gate each next step; every action is audit-logged.
Records upload
Medical records upload with encryption at rest; only the care team sees the documents.
Review package
Form 3926 generates from the structured record; physician reviews, edits, and files.
Document handling: uploads are encrypted at rest and in transit, accessible only to the verified care team on the request, and retained per the study’s record-retention agreement.