Risk-Based Clinical Research Quality Consulting

Risk-Based Clinical Oversight.
Data-Driven Quality.

Enova partners with sponsors, CROs, and research organizations to strengthen clinical oversight and quality systems. Together we apply risk-based quality management to guide operations, audits, and regulatory readiness across complex clinical programs.

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Clinical Monitoring RBQM Inspection Readiness GCP · GLP · GCLP Auditing Clinical Operations Quality Systems

Global Regulatory Reach  ·  FDA  •  EMA  •  MHRA  •  PMDA  •  Health Canada  •  TGA

15+ Years Clinical Research Experience
120+ Studies Supported
50+ Client Organizations
20+ Countries
About the Firm

Structured, risk-based consulting for clinical research organizations.

Enova Medical Group is a clinical research consulting firm providing senior-led support across the operational and quality demands of complex research programs.

Risk-based quality management is the firm's working methodology, applied to clinical operations, auditing, quality systems, and oversight strategy across U.S. and global environments.

Engagements are structured to deliver specific outcomes: stronger quality systems, cleaner documentation, inspection-ready teams, and oversight frameworks built to withstand regulatory scrutiny. Operational depth, not generalist advisory.

Organizations We Support

Sponsors
Contract Research Organizations
Biotech Companies
Medtech Organizations
Diagnostics Firms
Academic Research Institutions
Clinical Sites
Laboratories
Firm At a Glance
GCP.
GCP, GLP, and GCLP frameworks across FDA and ICH standards
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, all informed by risk-based thinking. The focus is always defined deliverables and measurable quality outcomes.

01 / Core Pillar
Clinical Operations & Oversight

Senior-led monitoring strategy, risk-informed 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
RBQM, Data Governance & Global Compliance

Risk-based quality management replaces uniform monitoring with KRI/KPI-driven oversight calibrated to each protocol's specific risk profile. Applied across monitoring strategy, regulatory compliance, and data governance.

  • RBQM strategy using KRIs and KPIs
  • Clinical data governance and integrity
  • Regulatory 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.
Clinical Archiving & Information Governance
GCP/GLP/GCLP-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.
Strategic Quality and Compliance Leadership
01
Fractional Quality Leadership

Executive-level quality oversight for organizations that require experienced advisory support without a full-time internal executive. Engagements cover quality strategy, QMS governance, audit leadership, inspection readiness, and quality risk management.

Designed for organizations in growth phases, preparing for regulatory inspection, or undergoing quality remediation, where senior quality leadership needs to be applied directly to the program rather than delegated downward.

02
Quality Management Systems (QMS)

Design, implementation, and oversight of Quality Management Systems aligned with GCP, GLP, and GCLP requirements.

Scope includes inspection readiness strategy, structured audit programs, CAPA governance, and quality risk management, all calibrated to FDA and ICH expectations.

03
Computer System Assurance (CSA) and Validation (CSV)

CSA and CSV approaches aligned with modern regulatory expectations, including FDA CSA guidance and 21 CFR Part 11. Risk-based validation strategies applied to clinical data platforms, eTMF systems, and regulated digital infrastructure.

How We Work

Structured engagement. Clear outcomes.

Enova does not offer open-ended advisory. Every engagement is scoped to defined deliverables, timelines, and measurable quality outcomes, agreed in writing before work begins.

The firm operates as a strategic partner. Regulatory priorities, quality risk profile, and success criteria are established at the outset and drive every phase of delivery.

01
Discovery & Alignment
Assess current-state quality, risk profile, documentation practices, and regulatory posture. Map KRI priorities and define engagement scope with precision before 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, with operational depth rather than surface familiarity.

Coverage spans RBQM, GCP/GLP/GCLP, FDA and ICH-GCP compliance, ISO quality systems, and eTMF and data governance standards applied across global trial environments.

Enova does not provide legal advice or guarantee regulatory outcomes. Consulting support is strategic and operational in nature.
FDA 21 CFR & Federal Regulations
ICH-GCP E6(R2) & E6(R3)
GCP Good Clinical Practice
GLP Good Laboratory Practice
GCLP Good Clinical Lab Practice
21 CFR Part 11 Electronic Records & Signatures
ISO 9001 Quality Management · 2015
ISO 14155 Medical Devices · 2020
RBQM Risk-Based Quality Management
KRI / KPI Risk & Performance Indicators
eTMF Trial Master File
CAPA Corrective & Preventive Action
Dr. Rashad Lewis
Principal Consultant · Senior CRA
Clinical Research Operations Strategist · ACRP-CP Certified
15+ years across Phase I–IV trials, observational registries, medical device studies, and global GCP, GLP, and GCLP environments.
  • ACRP-CP Certified, Association of Clinical Research Professionals
  • Senior Clinical Research Associate (CRA)
  • GCP / GLP / GCLP 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 led by Dr. Rashad Lewis, a senior clinical research professional with direct experience across trial monitoring, auditing, RBQM implementation, quality system design, and regulatory operations. The firm's capabilities are grounded in practice, not arms-length advisory.

Dr. Lewis's expertise spans audit execution across GCP, GLP, and GCLP environments; RBQM strategy and implementation; QMS design and CSA/CSV; and IVD and medical device clinical investigations. Operational experience covers multinational trial coordination and inspection preparation across therapeutic areas and study types.

Enova's model reflects a straightforward premise: organizations operating in complex regulatory environments deserve senior expertise applied directly to their programs, not junior execution against a senior-authored plan.

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 QMS Design CSV & CSA Quality Risk Management 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. The firm applies risk-based quality management (RBQM) as the strategic methodology across clinical operations, quality systems, GCP/GLP/GCLP auditing, inspection readiness, and global regulatory compliance.

Enova works with sponsors, CROs, biotech, medtech, diagnostics organizations, academic 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. At Enova, RBQM is not a standalone service: it is the underlying framework that informs monitoring strategy, oversight models, and quality decisions across every engagement.
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 project, retainer, or embedded FSP models depending on scope, duration, and organizational need. All engagements begin with a structured scoping conversation. Deliverables, timelines, and success criteria are agreed 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 relationship, the first step is 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
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