Regulated clinical research infrastructure

Turn Urgent Patient Demand Into Compliant Clinical Infrastructure.

BeaconCR helps physicians and sponsors transform patient access requests into compliant expanded-access workflows, structured registry enrollment, real-world evidence, and FDA-ready clinical development infrastructure.

Expanded Access (FDA Form 3926)For Physicians:Launch a Study For Patients: Refer Your Physician
Physician-ledHIPAA-aware intakeOutcome trackingPublication-ready reports

Step 1 of 8

Idea

Transform a therapeutic, registry, or study concept into a structured clinical research pathway.

Lifecycle step 1 of 8: Idea

HIPAA-Aware InfrastructureEncrypted PHI StorageAudit-Logged AccessNot a Treatment Provider

What BeaconCR is

Regulated clinical infrastructure — not a treatment provider — that physicians and sponsors use to convert urgent patient demand into compliant, documented, FDA-ready workflows.

Expanded Access

FDA Form 3926 intake, physician review, and review-ready compassionate-use packages.

Registry Enrollment

Structured observational registries with consent-aware intake and longitudinal follow-up.

Real-World Evidence

Structured outcome capture and analysis-ready, sponsor-grade reporting.

Clinical Development

FDA-ready infrastructure that scales from access requests to formal study programs.

Choose Your Path

Three ways to begin with BeaconCR. Pick the one that fits where you are.

I'm a Physician

You use a therapy, device, biologic, procedure, or care model and want to collect structured outcomes data — without building research infrastructure.

Start a Physician Registry

I'm a Biotech Sponsor

You need real-world evidence, activated study sites, registry infrastructure, physician investigators, or longitudinal patient follow-up.

Build a Sponsor Registry

I'm a Patient or Caregiver

You want your treating physician to track your outcomes in a structured study. Bring BeaconCR to your doctor — they open the study, you take part.

Refer Your Physician

Collaborating as a CRO, academic, or data partner? Explore research partnerships

Flagship workflow

The FDA Form 3926 Expanded Access Workflow

When a patient needs access to an investigational therapy, BeaconCR gives the treating physician a compliant, end-to-end pathway — from secure intake to a review-ready FDA Form 3926 package. BeaconCR builds the documentation; the physician makes every clinical and regulatory decision.

1

Patient / caregiver intake

Secure, consent-aware intake captures the request and the treating physician.

2

Medical record upload

Token-gated, encrypted upload of supporting clinical records.

3

Physician review

The treating physician reviews eligibility and the clinical rationale.

4

Encrypted PHI storage

PHI is encrypted at rest (AES-256-GCM) and every access is audit-logged.

5

Editable FDA Form 3926

A pre-filled, editable Form 3926 is generated from the structured record.

6

Review-ready package

A complete expanded-access package, prepared for physician and regulatory review.

See the Expanded Access Pathway Begin a Patient Intake

BeaconCR prepares documentation and infrastructure only. It does not provide treatment, supply biologics, authorize access, or guarantee FDA, IRB, or physician approval. All clinical and regulatory decisions remain with the treating physician and sponsor.

For Physicians & Clinics

Start a Physician-Led Registry Without Building Research Infrastructure From Scratch

BeaconCR helps physicians turn clinical observations, therapy protocols, biologic/device use, and care models into structured registry workflows — with study draft support, IRB-ready documentation, patient intake, HIPAA-aware outcomes capture, evidence reporting, and publication planning.

1

Start free study workspace

Open a physician workspace and begin a guided observational study draft.

2

Build the draft protocol

Enter therapy concept, conditions, design, outcomes, and enrollment plan in small editable steps.

3

Receive registry readiness review

See which sections are complete and which need a professional second look before submission.

4

Submit for quality review + PRS support

BeaconCR refines ClinicalTrials.gov-style language and supports PRS registration submission.

5

Activate patient intake and outcomes tracking

Turn on structured intake, HIPAA-aware data capture, and longitudinal follow-up workflows.

6

Generate evidence and publication-ready reports

Produce sponsor-ready summaries, evidence packages, and publication-ready documentation.

Start Physician Study Free Book Registry Strategy CallExplore the PRO Intelligence Layer
For Biotech Sponsors

Registry Infrastructure and Real-World Evidence Programs

Run physician-led registries and real-world evidence programs without standing up your own site network. BeaconCR activates investigators, captures structured outcomes, and delivers analysis-ready data and publication support.

Activated sites & investigators

Physician-led sites onboarded with intake, consent-aware workflows, and structured data capture from day one.

Structured real-world evidence

Longitudinal outcomes, patient- and caregiver-reported measures, and clean machine-readable exports for your analysis teams.

Publication & regulatory support

Evidence packages and publication-ready documentation built to stand up to sponsor, IRB, and regulatory review.

Schedule a Registry Build Call See Sponsor Solutions
For Patients, Families & Caregivers

Bring Your Doctor. Your Doctor Opens the Study.

BeaconCR is not a treatment provider — it’s the infrastructure your physician uses to run a structured registry. If you’d like your outcomes tracked in a study, the first step is simple: tell your treating doctor about BeaconCR. They open the study; you take part.

1

Tell your doctor about BeaconCR

Share BeaconCR with your treating physician. They can open a free workspace in minutes — no research infrastructure needed on their end.

2

Your doctor opens a registry

Your physician sets up a structured observational registry or compassionate-use framework and decides what is clinically appropriate for you.

3

You take part in structured outcome tracking

Once your doctor's registry is active, your outcomes are recorded over time — securely, HIPAA-aware, and in a research-ready format.

Refer Your Physician I Am a Physician How We Handle Your Information

BeaconCR provides research infrastructure, not treatment. Referral or intake does not guarantee study enrollment, physician approval, FDA authorization, IRB concurrence, or therapeutic outcome. Medical decisions remain with licensed physicians.

How BeaconCR works

Start free. Build your draft. Pay only when you're ready for review. Manage your active registry month-to-month.

1

Start Your Study Free

Create a physician workspace and begin a guided study draft. No payment, no card, no commitment.

2

Build the Study Draft

Enter your study concept, description, conditions, design, outcomes, and enrollment plan — saved in small steps, edit anytime.

3

Registry Readiness Score

BeaconCR shows which sections are complete and which need a professional second look before submission.

4

Pay $499 for Quality Review + PRS Submission

BeaconCR reviews your draft, refines ClinicalTrials.gov-style language, and supports your PRS registration submission.

5

Activate $119/month Management

Once your study is submitted, published, or activated, ongoing registry management runs on a simple monthly subscription.

6

Maintain Your Registry

Dashboard access, patient enrollment, outcome tracking, registry updates, and completion monitoring — all in one place.

See the full step-by-step

How BeaconCR is applied

Six real-world use case patterns across physician-led registries, biotech sponsor programs, and compassionate-use pathways. Examples are illustrative and anonymized to protect participant and sponsor identities.

Orthobiologic

Orthobiologic Registry

A regenerative-medicine clinic capturing knee outcomes from PRP and bone-marrow-aspirate injections across multi-year follow-up — without building research infrastructure in-house.

  • •Drafted an observational registry protocol with validated PRO instruments (KOOS, NRS pain)
  • •Prepared IRB-ready submission package and coordinated with external commercial IRB
  • •Built physician-referral patient intake with HIPAA-aware authorization
  • •Configured 3, 6, 12, and 24-month follow-up cadence with patient reminders
See For Physicians

Slide 1 of 6

Use case patterns above are illustrative and anonymized. BeaconCR does not publish identifiable case studies without explicit sponsor, physician, and (where applicable) patient consent. Observational registry data is hypothesis-generating and is not equivalent to RCT data.

Live example

Kurve Therapeutics runs its compassionate-use program on BeaconCR — a working example of the platform at work, end to end.

See the program

Free download

The Physician Registry Launch Checklist

35 concrete steps across 7 phases to take a clinical observation from idea to a registered, IRB-ready observational registry. No tracking pixels. No drip sequence. One email with the link.

Get the checklist

Simple Pricing for Clinical Research Onboarding

Start free, pay for expert review when ready, and maintain active registries month-to-month.

Free Study Builder

Start with your clinical idea. No card required.

Free
$0 to start
Start Your Study Free
SUBMIT WITH REVIEW

Quality Review + PRS Registration Submission

Submit your study with professional review.

$499
$499 one-time
Begin $499 Quality Review

Ongoing Registry Management

Maintain your active study month-to-month.

$119
$119 / month / active study
See $119 Monthly Plan
See full pricing details

Payment does not guarantee ClinicalTrials.gov acceptance, IRB approval, patient enrollment, publication, or therapeutic outcome. All registry, regulatory, ethical, and safety oversight remain with applicable physicians, IRBs, sponsors, and regulators.

Your Quality Reviewer

Every Quality Review is performed by BeaconCR’s credentialed PI of record.

The BeaconCR Team

Quality Review & Principal Investigator of Record

BeaconCR operates under a credentialed Principal Investigator of record with a Master’s in Biopharmaceutical Regulatory Affairs, cGMP cell-therapy manufacturing experience, and active responsibility on multiple ClinicalTrials.gov-registered observational studies. Every Quality Review is performed by BeaconCR’s credentialed team — bringing the regulatory machinery of large-CRO operations to independent physicians, biotech sponsors, and patient-access programs.

  • • MS, Biopharmaceutical Regulatory Affairs
  • • BS, Chemistry (Biochemistry Focus)
  • • cGMP Cell Therapy Manufacturing & Cleanroom Operations
  • • Principal Investigator — ClinicalTrials.gov (multiple active observational studies)
  • • Compassionate-use and expanded-access program experience across multiple indications
Book a Registry Strategy CallAbout BeaconCR

Your therapy deserves to be on the record.

Create a free study workspace, build your registry draft at your own pace, and pay $499 only when you're ready for Quality Review + PRS Registration Submission.

Start Your Study Free See pricing