Phoenix · Integrated Research Organization

Born in the Sonoran Desert, Devreux Sciences embeds clinical research within the practices where care already lives — bringing tomorrow's therapies to the patients of today, and producing data that earns its trust.

4wk
Target Site
Activation
GCP + ALCOA+
Compliance Framework
24/7
On-Call PI
for Safety
Sonoran Desert · HQ
Where rigorous science meets community-based care.
Phoenix Operations · Live
Compliance Framework
Phase II–IV FDA 21 CFR Parts 11, 50, 54, 56, 312 ICH E6(R2/R3) GCP HIPAA BIMO-Ready
SECTION I
The Ecosystem

Built for the three audiences clinical research must serve.

An Integrated Research Organization unites sponsors, investigators, and study participants within a single operational framework, removing the friction that traditionally separates trial demand from community-based care delivery.

Sponsors & CROs

Accelerated site qualification, protocol-matched enrollment from diverse populations, and inspection-ready source documentation across all phases of execution.

01 / Sponsors

Investigators & Practices

We assume the regulatory, contractual, and operational responsibilities of clinical research, allowing investigators to maintain focus on patient care while contributing to the evidence base.

02 / Investigators

Study Participants

Access to investigational therapies through a familiar care setting, with informed consent practices, dedicated coordination, and protocol-compliant subject support.

03 / Participants
0weeks
Average Site
Activation
Track Record
Meeting Enrollment
Commitments
ALCOA+
Aligned
GCP & 21 CFR
Operations
24/7
On-Call PI for
Safety Events
CLINICAL TRIAL LIFECYCLE · ICH-GCP 1 PRE-SCREEN EHR review 2 CONSENT 21 CFR 50 3 SCREEN I/E criteria 4 RANDOMIZE First Pt In 5 TREAT Visit window 6 DB LOCK SDV complete CONTINUOUS: — Pharmacovigilance / SAE reporting — Source data verification — PI oversight & delegation log — IRB amendments & reporting
Trial Lifecycle · ICH-GCP
Capability 01

Embedded research infrastructure within real clinical practice.

Devreux operates inside the practices where patients already receive care. This proximity to clinical workflow accelerates enrollment, improves retention, and produces source documentation that reflects authentic patient experience rather than research-only encounters.

  • Direct integration with EHR systems for source documentation
  • Investigator workflow designed around standard-of-care visits
  • Subject retention rates that protect study power
  • Reduced screen-failure attributable to artificial recruitment channels
REGULATORY BINDER STRUCTURE § 1 — PROTOCOL & AMENDMENTS 21 CFR 312 § 2 — INVESTIGATOR BROCHURE ICH E6(R3) § 3 — FORM FDA 1572 21 CFR 312.53 § 4 — IRB APPROVAL & ICF 21 CFR 50, 56 § 5 — DELEGATION OF AUTHORITY PI logs § 6 — SOURCE DATA & CRFs ALCOA+ § 7 — SAE / SUSAR REPORTS 21 CFR 312.32
Regulatory · ISF Structure
Capability 02

Inspection readiness as a continuous state, not a milestone.

Investigator Site Files, training documentation, and source records are maintained to a standard that allows immediate review by FDA inspectors, sponsor monitors, or independent auditors. We build for scrutiny because the cost of remediation always exceeds the cost of doing it correctly the first time.

  • 21 CFR Part 11 compliant electronic source documentation
  • ALCOA+ data integrity principles applied throughout the trial lifecycle
  • Continuous BIMO-readiness aligned to FDA inspection methodology
  • Independent quality assurance review prior to monitoring visits
SECTION II
Operational Capabilities

Six commitments aligned to regulatory expectations.

Our operating model is anchored to the standards FDA and sponsor monitors evaluate during routine and for-cause inspections, not to vanity metrics that obscure execution risk.

01

Site Qualification & Activation

Master CTA · Form 1572 · 1571

Site qualification visits, master clinical trial agreement frameworks, and pre-positioned regulatory documentation enabling activation within sponsor-required timelines, typically four weeks from CDA execution.

02

Principal Investigator Oversight

21 CFR 312.50 · 312.60

Qualified principal investigators meeting FDA Form 1572 requirements, with documented delegation of authority, on-call availability for safety events, and continuous oversight of protocol adherence.

03

Data Integrity & Source Documentation

21 CFR Part 11 · ALCOA+

Electronic source documentation systems compliant with 21 CFR Part 11, real-time source data verification, and continuous audit trail integrity meeting ALCOA+ principles.

04

Enrollment vs. Commitment

21 CFR Part 50 · IRB-Approved

IRB-approved recruitment materials and broad enrollment reach across the Phoenix metropolitan region, paired with retention programs designed to meet contracted enrollment commitments.

05

GCP & Regulatory Compliance

ICH E6(R2/R3) · 21 CFR Parts 50, 54, 56

Central and local IRB submission management, financial disclosure under 21 CFR Part 54, expedited safety reporting, and ongoing protocol amendment governance.

06

Inspection Readiness

FDA BIMO · Sponsor Audits

Continuous inspection readiness aligned to FDA Bioresearch Monitoring Program standards, with regulatory binders, training records, and source documents maintained for immediate review.

SECTION III
Therapeutic Areas

Concentrated depth, with capacity to expand on demand.

We focus where protocol complexity, recruitment difficulty, and operational specialization most directly determine trial success. New therapeutic areas are added to support sponsor-specific programs.

TA-01

Cardiology

Heart failure / Lipidology / Structural heart

Phase II–IV programs in advanced heart failure, novel lipid-modifying therapies, and structural heart device studies, supported by access to cardiac imaging and procedural capabilities.

TA-02

Podiatry

Diabetic foot / Wound care / Lower extremity

Diabetic foot ulcer therapeutics, advanced wound care interventions, and lower-extremity device evaluations conducted by board-certified podiatric investigators.

TA-03

Gastroenterology

IBD / MASH-NASH / Functional GI

Inflammatory bowel disease, metabolic dysfunction-associated steatohepatitis, and functional GI trials with access to endoscopic and biopsy support for protocol-required procedures.

TA-04

Pulmonology

COPD / Asthma / Interstitial lung disease

Chronic obstructive pulmonary disease, severe asthma biologics, and interstitial lung disease research supported by access to pulmonary function testing infrastructure.

+ Additional therapeutic areas onboarded per sponsor protocol — contact for capability expansion

Activation speed is meaningful only if the data holds up under any standard of regulatory scrutiny.

We measure ourselves not by how quickly we open a study, but by how cleanly we close one.

Research belongs inside clinical practice, not adjacent to it.

The participant's experience is part of the protocol, not separate from it.

A source document should be ready for any reviewer, on any day, without preparation.

Senior Clinical Operations Leadership
SECTION IV
Service Lines

Three integrated capabilities, one accountable team.

From feasibility through database lock, every service is delivered by the same senior leadership, eliminating handoffs that introduce risk into the conduct of the study.

SVC 01

Feasibility & Site Activation

Protocol feasibility assessment, sponsor budget and contract negotiation, regulatory submission packet preparation, and accelerated activation aligned to enrollment timelines.

SVC 02

Trial Conduct & Monitoring

End-to-end study coordination, source data verification, sponsor monitoring support, and 24/7 principal investigator oversight for inpatient and complex outpatient protocols.

SVC 03

Regulatory Affairs & Recruitment

IRB submission management, expedited safety reporting under 21 CFR 312.32, financial disclosure tracking, and IRB-approved recruitment strategy execution.

SECTION V
Inquiries

Ready to partner?

Whether you are a sponsor evaluating site capabilities, an investigator exploring research integration, or a prospective participant inquiring about trial access, we welcome the conversation.

Office
Phoenix, Arizona
Hours
Monday – Friday, 9:00 – 17:00 MST