Skip to main content
Clinical Research Quality and Compliance Consulting

Structured Oversight.
Operational Depth.
Global Reach.

Enova Medical Group provides senior-led consulting across clinical operations, quality systems, auditing, and regulatory compliance — for sponsors, CROs, and research organizations navigating complex clinical environments.

Request a Consultation Email Enova →
About the Firm

Precision consulting for clinical research organizations.

Enova Medical Group is a clinical research consulting firm providing structured, senior-led support across the operational and quality demands of complex research programs. The firm works across U.S. and global clinical research environments, supporting organizations that require disciplined oversight, strong regulatory grounding, and consistent execution.

Enova's model is built around operational depth, not breadth of generalist service. Each engagement is structured to deliver specific outcomes: stronger quality systems, cleaner documentation, better-prepared teams, and programs that can withstand regulatory scrutiny.

Organizations We Support

Sponsors
Contract Research Organizations
Biotech Companies
Medtech Organizations
Diagnostics Firms
Academic Research Institutions
Clinical Sites
Laboratories
Firm At a Glance
GxP.
Compliant across FDA, ICH, and global quality frameworks
FSP.
Embedded functional service provider models available
3+
Core capability pillars with disciplined delivery
US / GL
U.S. and global clinical research support
Inspection Ready Senior-Led Audit-Grade Quality Regulatory Depth
Service Capabilities

Where clinical precision meets quality execution.

Enova's capabilities are organized around three core pillars, supported by specialized service areas. The focus is always clear deliverables, not open-ended advisory arrangements.

01 — Core Pillar
Clinical Operations & Oversight

Senior-led monitoring strategy, site oversight, and operational governance across the study lifecycle — from startup through closeout.

  • Monitoring strategy and site visit support
  • Adverse event and documentation oversight
  • Vendor, CRO, and FSP management
  • Site selection, contracting, and budgeting
  • Process improvement and workflow optimization
02 — Core Pillar
Quality, Auditing & Regulatory Readiness

Structured audit execution, quality system design, and inspection preparation grounded in GCP, GLP, and GCLP requirements.

  • GCP, GLP, and GCLP auditing
  • eTMF compliance and documentation review
  • QMS design aligned to ISO 9001
  • Inspection readiness and CAPA support
  • SOP development and team preparation
03 — Core Pillar
Global Compliance, RBQM & Data Governance

Risk-based quality management, regulatory compliance strategy, and data governance frameworks for multinational and domestic programs.

  • RBQM strategy using KRIs and KPIs
  • Clinical data governance and integrity
  • GxP archiving and documentation compliance
  • Multinational regulatory alignment
  • Global trial coordination and oversight
IVD & Medical Device Programs
Clinical investigation support for in vitro diagnostics and medical devices under ISO 14155 and applicable FDA guidance.
GxP Archiving & Information Governance
GxP-compliant archiving frameworks, informatics-informed documentation management, and data security governance.
Leadership, Training & CRA Development
CRA mentoring, audit preparation training, and quality-focused capability building for clinical research teams.
How We Work

Structured engagement. Clear outcomes.

Enova does not offer open-ended advisory arrangements. Every engagement is scoped to defined deliverables, specific timelines, and measurable quality outcomes. The firm operates as a strategic partner — not a supplemental resource.

Engagements begin with a structured discovery conversation. Before work begins, scope, deliverables, regulatory priorities, and success criteria are agreed upon in writing.

01
Discovery & Alignment
Assess current-state quality, operational risks, documentation practices, and regulatory posture. Define the engagement scope with precision before any work begins.
02
Strategy & Delivery Planning
Develop a targeted plan with defined deliverables, timelines, regulatory checkpoints, and quality benchmarks specific to your program.
03
Execution & Oversight
Deliver against scope — audits, site oversight, RBQM implementation, documentation governance, vendor management, or team preparation — with full accountability.
04
Review & Knowledge Transfer
Validate outcomes, document findings, and transition controls and knowledge to your team. Engagements close with your organization in a stronger position than at the start.
Regulatory Frameworks

Operational fluency across global standards.

The clinical research regulatory environment is complex, overlapping, and constantly evolving. Enova Medical Group maintains applied expertise across the frameworks that govern U.S. and international clinical research — not familiarity, but operational depth.

This includes GCP, GLP, and GCLP auditing; FDA and ICH-GCP compliance; ISO quality systems for clinical research and medical devices; and risk-based quality frameworks designed for global trial environments.

Enova does not provide legal advice or guarantee regulatory outcomes. Consulting support is strategic and operational in nature.
FDA21 CFR & Federal Regs
ICH-GCPE6(R2) & E6(R3)
GCPGood Clinical Practice
GLPGood Laboratory Practice
GCLPGood Clin. Lab Practice
GxPAll Good Practice Frameworks
ISO 9001Quality Mgmt · 2015
ISO 14155Medical Devices · 2020
RBQMRisk-Based Quality Mgmt
KRI / KPIRisk & Performance Indicators
eTMFTrial Master File
CAPACorrective & Preventive Action
Dr. Rashad Lewis
Principal Consultant · Senior CRA
Clinical Research Operations Strategist · ACRP-CP
  • Senior Clinical Research Associate (CRA)
  • GCP / GxP Compliance Specialist
  • RBQM Strategy and Implementation
  • GCP, GLP & GCLP Audit Experience
  • IVD & Medical Device Trial Management
  • eTMF Oversight and Data Governance
  • Inspection Readiness and CAPA Management
  • U.S. and Global Clinical Research Environments
Principal & Leadership

Senior-led. Clinically grounded.

Enova Medical Group is structured and led by Dr. Rashad Lewis, a senior clinical research professional with direct experience across trial monitoring, auditing, quality system design, compliance oversight, and regulatory operations. The firm's capabilities are grounded in hands-on clinical research practice, not advisory distance.

Dr. Lewis brings applied expertise across GCP, GLP, and GCLP auditing; RBQM strategy; eTMF compliance; IVD and medical device clinical investigations; multinational trial coordination; and inspection preparation across therapeutic areas and study types.

Enova's consulting model reflects a direct premise: organizations navigating complex clinical and regulatory demands deserve senior-level expertise applied directly to their programs — not junior execution against senior framing.

Enova engages as a structured consulting firm. Inquiries are handled at the principal level, and engagements are scoped and delivered with senior oversight throughout.
Clinical Monitoring GCP Auditing GLP Auditing GCLP Auditing RBQM Inspection Readiness eTMF Compliance IVD Programs Medical Device Trials Global Trial Support Data Governance CAPA Management
FAQ

Common questions.

Questions not addressed here can be directed to the firm through the contact form below.

Enova Medical Group is a clinical research consulting firm providing senior-led support across clinical operations, quality systems, GCP/GLP/GCLP auditing, RBQM, inspection readiness, data governance, and global regulatory compliance. The firm works with sponsors, CROs, biotech, medtech, diagnostics organizations, academic research institutions, sites, and laboratories.
Yes. GCP, GLP, and GCLP auditing are core components of Enova's Quality, Auditing, and Regulatory Readiness practice. Audit support is conducted against FDA requirements, ICH-GCP guidelines, and applicable global standards, with attention to documentation quality, process compliance, and inspection preparedness.
Risk-Based Quality Management (RBQM) is a data-driven oversight framework that uses Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to focus monitoring resources where quality risks are highest. Enova designs RBQM frameworks calibrated to a study's specific protocol, site network, and risk profile — replacing uniform monitoring models with structured, evidence-based oversight.
Yes. Inspection readiness support includes systematic eTMF review, SOP assessment, CAPA evaluation, audit trail analysis, deviation log review, and team preparation for regulatory inspection conduct. The goal is to identify and close documentation gaps before they become regulatory findings.
Yes. Enova has specific experience supporting early-stage biotech and medtech companies establishing quality infrastructure, developing SOPs, and preparing for their first regulatory submissions or audits. Building compliant systems from the start is substantially more effective than remediating under regulatory pressure.
Yes. Enova provides clinical operations and quality support for in vitro diagnostic (IVD) and medical device studies under ISO 14155 and applicable FDA guidance, including site management, safety data oversight, performance documentation, and approval readiness support.
Engagements are available on a project, retainer, or embedded FSP model depending on scope, duration, and organizational need. All engagements begin with a structured scoping conversation. Deliverables, timelines, and success criteria are agreed upon before work begins. Enova does not operate on open-ended advisory retainers without defined outcomes.
Contact

Start the conversation.

Use the form to describe your organization and the challenge you're addressing. All inquiries are reviewed promptly, and Enova Medical Group responds within one business day.

Whether you need immediate support on a specific quality issue, or are evaluating a longer-term consulting relationship, the first step is the same: a direct conversation about what your program actually requires.

Inquiries reviewed at the principal level
Response within one business day
Project, retainer, and FSP models available
U.S. and global programs supported
Send an Inquiry

Your information is handled with complete confidentiality and is not shared with third parties.

Inquiry Received

Thank you. Your inquiry has been received. Enova Medical Group will follow up shortly.