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BeaconLife Sciences

Clinical research organization

From first protocol to published evidence.

Beacon Clinical Research pairs regulatory and study-operations expertise with one platform for consent, data capture and patient-reported outcomes — so physician-led and early-stage studies are run the way a large sponsor would run them.

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Registered studies
4 on ClinicalTrials.gov
Ethics oversight
Healing Hope International
Compliance design
21 CFR Part 11 · HIPAA
Study workspace · DEMO-OBS-001

Enrolled

48

+6 this month

Visits complete

92%

baseline → 3 mo

Open queries

3

median 1.2 days

PNOS-P total score, mean by visit

ePRO

  • Consent v2.0.0 signedP-017 · e-signature · reason: re-consent
  • Query closedSystolic BP · confirmed against source
  • Correction approvedItem 14 · 2 → 1 · reason recorded
  • Visit lockedBaseline · hash-chained audit entry
Illustration · synthetic data

Studies sponsored by Healing Hope International · supported by Beacon — verify on ClinicalTrials.gov

Clinical research services

The regulatory and operational work, done properly.

Every engagement is led by our credentialed regulatory team. Clinical decisions always remain with licensed clinicians.

Study start-up & site activation

Feasibility, protocol development to GCP, site onboarding and the calibration call that scopes the work.

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Regulatory affairs

IND preparation, FDA correspondence, orphan-drug and expedited-pathway strategy, IRB readiness.

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ClinicalTrials.gov registration

PRS record drafting and submission through to an NCT number, then ongoing results maintenance.

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Expanded access

Single-patient and intermediate-size programs: physician packets, FDA Form 3926, IRB and manufacturer coordination.

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Observational & real-world evidence

Registry-based and observational designs that produce publishable, defensible outcome data.

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Quality review & study management

Independent quality review before submission and month-to-month management once a study is live.

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The Beacon platform

One system for the whole study record.

Study design, consent, visit data and participant-reported outcomes live in one place, with every change attributable, reasoned and preserved.

Explore the platform Trust Center

EDC & study builder

Versioned forms, server-side edit checks, queries, source-data verification, visit locking.

ePRO / eCOA

Published instruments with deterministic scoring and a reviewed correction trail.

eConsent

Versioned consent with comprehension checks, e-signature, signed PDF and automatic re-consent.

Registry & recruitment

Pre-screening, self-registration and longitudinal follow-up with identity held separately.

Security & audit

Encryption at rest, MFA for every staff account, and a hash-chained audit trail of every action.

Public API

OAuth 2.0 client credentials, scoped tokens and an OpenAPI 3.1 reference with a sandbox.

How an engagement runs

Four stages, one accountable team.

  1. 01

    Calibration call

    Thirty to sixty minutes to confirm the therapy fits an observational or expanded-access pathway and agree the scope.

  2. 02

    Protocol & registration

    Protocol written against GCP and applicable standards; ClinicalTrials.gov PRS submission through to an NCT number.

  3. 03

    Consent, capture, follow-up

    Participants consent and report outcomes on the platform; sites enter visit data with edit checks and queries.

  4. 04

    Analysis & next step

    Locked, auditable data for publication — and, where it fits, the foundation for an IND or designation request.

Case study

A sponsor’s registry and expanded-access program, end to end.

Beacon runs participant intake, physician and site coordination, compassionate-use requests and longitudinal outcome questionnaires for a sponsor’s observational study registered as NCT07521384.

See the program

  • Participant enrollment

    Self-service intake with consent and identity held apart from outcome data.

  • Physician coordination

    Site and physician intake, credential capture and referral pathways.

  • Compassionate use

    Physician-supported requests with records upload and Form 3926 preparation.

  • Outcome follow-up

    Baseline, one- and three-month questionnaires with scoring and review.

Our team

Regulatory science and the cleanroom, in one team.

Beacon Clinical Research 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 our credentialed team — bringing the regulatory machinery of large-CRO operations to independent physicians, biotech sponsors, and patient-access programs.

Credentials and affiliations
  • M.S., Regulatory Affairs — Northeastern University
  • Graduate Certificate, Biopharmaceutical International Regulatory Affairs — Northeastern University
  • B.S., Chemistry (biochemistry concentration) — University of Louisiana at Lafayette
  • Two years of cGMP cell-therapy manufacturing and cleanroom operations
  • Principal investigator of record on ClinicalTrials.gov-registered observational studies
  • Good Clinical Practice (NIH) · HIPAA · CITI conflict-of-interest training

For developers

Automate the study with our API.

curl -s https://beaconcr.com/api/v1/oauth/token \
  -d grant_type=client_credentials \
  -d client_id=$CLIENT_ID -d client_secret=$CLIENT_SECRET

curl -s https://beaconcr.com/api/v1/studies \
  -H "Authorization: Bearer $TOKEN"
Developer portal

Pricing

Start free. Pay for review. Then month-to-month.

  • Free Study BuilderStart with your clinical idea. No card required.Free to start
  • Quality Review + PRS Registration SubmissionSubmit your study with professional review.One-time engagement
  • Ongoing Registry ManagementMaintain your active study month-to-month.Monthly, per active study
Full pricing

Your therapy deserves to be on the record.

Tell us about the study. We will tell you, plainly, what it takes to run it well.

Start a studyContact us