Clinical Monitoring.
GxP Auditing.
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.
Global Regulatory Reach · FDA • EMA • MHRA • PMDA • Health Canada • TGA
Trusted across the clinical research ecosystem
Senior-led clinical research consulting for complex development programs.
Enova Medical Group is a clinical research consulting firm delivering senior-led support across clinical monitoring, GxP auditing, quality oversight, and regulatory compliance. Work spans biopharmaceutical trials, IVD studies, and medical device investigations operating under FDA regulations, ICH-GCP, ISO 9001, ISO 14155, and other global frameworks.
What separates Enova from a standard monitoring or auditing shop is the methodology behind the work. Quality by Design and Quality Risk Management function as complementary disciplines across every engagement. QbD identifies critical-to-quality factors and builds control strategies into the trial prospectively. QRM is the ongoing oversight engine that monitors whether those controls are holding throughout the study lifecycle. Together they produce programs that are not just compliant on paper but defensible under scrutiny.
The firm also engages when things have already gone wrong. Collapsed monitoring programs, aging CAPA backlogs, eTMF remediation ahead of submission, alliance and relationship breakdowns between sponsors and CROs, and studies heading toward a health authority inspection without the infrastructure to support one. Study rescue and remediation is a named service area because the need is real and the window to act is usually narrow.
Enova also brings something most clinical consultants do not: regulatory interpretation fluency grounded in both operational experience and formal health law training. Regulatory requirements are read as governance inputs, translated into practical frameworks, and applied to real study environments where teams have to execute against them daily.
Operational depth, not generalist advisory.
Organizations We Support
Where clinical precision meets quality execution.
Enova's capabilities span the full clinical trial lifecycle, from protocol input and site activation through closeout, inspection readiness, and remediation. Quality by Design and Quality Risk Management run through every engagement as the methodological foundation. The focus is always defined deliverables, regulatory defensibility, and measurable quality outcomes.
Clinical Monitoring and Trial Conduct
Risk-informed monitoring strategy and senior-led site oversight across the full study lifecycle. Monitoring at Enova is not a checkbox exercise. It is a structured quality activity tied to protocol-specific risk signals, quality tolerance limits, and real-time site performance data.
- Site feasibility, selection, and activation
- Site initiation visits, interim monitoring visits, and closeout visits
- Risk-based and remote monitoring strategy
- Protocol deviation identification and management
- Informed consent process oversight
- Investigational product and device accountability
- Pharmacy coordination and IP chain of custody
- Pharmacovigilance and SAE/SUSAR reporting oversight
- Lab kit design, central and local lab oversight, and specimen logistics
- Normal range management and lab manual development
- Enrollment tracking and site performance management
- Vendor, CRO, and FSP oversight and governance
- Budget negotiation, contract management, and milestone tracking
- Cross-functional team coordination and escalation management
GxP Auditing and Inspection Readiness
Structured GCP, GLP, and GCLP audit execution and inspection preparation grounded in FDA requirements, ICH-GCP guidelines, and applicable global standards. Audit findings are governance inputs that feed the QRM framework and drive meaningful quality improvements, not just deficiency lists.
- GCP, GLP, and GCLP auditing
- Sponsor, vendor, CRO, and site audits
- Audit trail review and deviation log management
- eTMF index management and compliance review
- Investigator site file and essential document oversight
- CAPA governance and effectiveness evaluation
- QMS design and alignment to ISO 9001
- SOP development, gap assessment, and version control
- Inspection readiness strategy and team preparation
- Health authority interaction support
Rescue. Remediate. Restore.
Not every engagement starts from a clean slate. Some programs arrive with monitoring that has collapsed, CAPA backlogs that have aged beyond acceptable thresholds, eTMF gaps that are a liability ahead of submission, or sponsor and CRO relationships that have broken down to the point where trial conduct is at risk.
Enova takes on study rescue and remediation engagements where the priority is stabilization first and sustainable quality second. The work is structured, sequenced, and executed with the same senior-level accountability as any other engagement. The difference is urgency and the recognition that the window to act is usually narrow.
If a health authority inspection is approaching and the program is not ready, that is a conversation worth having now.
Collapsed or inconsistent monitoring programs assessed, triaged, and rebuilt. Risk-based monitoring strategy reestablished with KRI frameworks aligned to current protocol and site risk profiles.
Aging or ineffective CAPA items evaluated for root cause accuracy, corrective action adequacy, and effectiveness check status. CAPA governance frameworks rebuilt to prevent recurrence and support inspection defense.
eTMF gap analysis conducted against the applicable TMF reference model and regulatory requirements. Missing, misfiled, and incomplete documents identified, tracked, and resolved ahead of submission or inspection.
Sponsor and CRO relationship breakdowns assessed and managed. Communication frameworks, escalation pathways, and governance structures rebuilt to restore functional trial conduct.
Rapid inspection readiness assessment covering eTMF, ISF, SOP currency, deviation log status, CAPA effectiveness, audit trail integrity, and team preparation. Gaps prioritized by regulatory risk and closed systematically.
QMS gaps identified and addressed. SOPs, deviation management processes, and quality oversight structures rebuilt or reinforced to support sustained compliance after the immediate crisis is resolved.
Supporting capabilities across every engagement.
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.
Clinical operations and quality support for in vitro diagnostics and medical device studies under ISO 14155 and applicable FDA guidance, including site management, device accountability, safety data oversight, performance documentation, and approval readiness. GxP principles and QRM methodology applied to device-specific risk profiles and regulatory requirements.
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.
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.
GxP-compliant archiving frameworks, documentation management, and data security governance across regulated digital infrastructure, aligned to FDA guidance, ICH standards, and 21 CFR Part 11.
ICH Q9(R1)-aligned QRM frameworks designed to detect risk early, respond proportionately, and maintain a continuous state of inspection readiness. RBQM strategy design using KRIs and KPIs, risk register development, critical-to-quality factor identification, and quality tolerance limit development.
Structured engagement. Clear outcomes.
Every engagement is scoped to defined deliverables, timelines, and measurable quality outcomes, agreed in writing before work begins. Quality by Design and Quality Risk Management are not services added at the end. They are the operating framework from day one, whether the engagement is a planned program build or an emergency remediation.
Ready to discuss your program?
Enova reviews every inquiry at the principal level and responds within one business day. Engagements are available on project, retainer, and embedded FSP models.
Structured engagement. Clear outcomes.
The most defensible clinical programs build quality into trial design before the first patient is enrolled. Identifying critical-to-quality factors, setting quality tolerance limits, and designing control strategies prospectively is not a regulatory formality. It is the difference between a program that manages deviations reactively and one that prevents them systematically.
KRI signals, deviation trends, and risk register updates are translated into forward-looking governance decisions before issues escalate into findings. A quality posture that waits for inspections to surface what structured monitoring would have caught earlier is not a quality posture. It is a liability.
Regulatory requirements carry legal weight, interpretive nuance, and strategic implications that purely operational backgrounds do not fully surface. Enova translates those requirements into practical governance frameworks so your team understands the rationale behind controls, not just the mechanics. That understanding is what holds up under scrutiny.
Quality systems and risk frameworks are built to function in real study environments, not idealized ones. An RBQM model that field teams cannot execute or a CAPA process that generates paperwork without closing root causes creates more risk than a simpler system that sticks. Every framework Enova delivers is designed to be used, not filed.
Operational fluency across global standards.
The clinical research regulatory environment is complex, overlapping, and continuously evolving. Enova maintains applied expertise across the standards that govern U.S. and international clinical research, with the depth to interpret requirements, not just execute against them.
GxP Compliance Specialist · ACRP-CP Certified
- DHSc, Nova Southeastern University
- Master of Jurisprudence in Health Law, Loyola University Chicago
- BS Biology, cum laude, North Carolina A&T State University
- ACRP-CP Certified, Association of Clinical Research Professionals
- Senior Clinical Research Associate
- GxP Compliance Specialist, GCP, GLP, and GCLP
- RBQM Strategy and Implementation
- U.S. and Global Clinical Research Environments
Senior-led. Clinically grounded.
"Quality that holds up under regulatory scrutiny is not built during inspection preparation. It is built into the study from the first protocol draft."
Dr. Lewis is a senior clinical research professional with 15+ years across Phase I-IV trials, observational registries, medical device investigations, and GxP environments spanning GCP, GLP, and GCLP. His work spans the full clinical development spectrum, from upstream protocol input and quality planning through site management, monitoring, pharmacovigilance oversight, GxP auditing, and inspection readiness across U.S. and global programs.
The foundation is cross-disciplinary by design. A Master of Jurisprudence in Health Law from Loyola University Chicago shapes how regulatory requirements are read and translated into operational governance. A DHSc from Nova Southeastern University grounds the work in health science research methodology. Fifteen years of direct trial execution across biopharmaceutical, IVD, and medical device programs is where both come to bear in practice.
That combination, regulatory science, legal interpretive fluency, and hands-on clinical operations experience, is what allows Enova to engage upstream on quality by design, manage risk systematically throughout execution, and step in when a program has gone off course and needs to be stabilized, remediated, and restored to a defensible state.
Specific experience includes GCP, GLP, and GCLP audit execution; SAE and SUSAR reporting oversight; IP and device accountability governance; lab kit design and central lab coordination; RBQM strategy and KRI/KPI framework development; ICH Q9(R1)-aligned quality risk management; QMS design aligned to ISO 9001; eTMF oversight and remediation; CAPA governance; CSA/CSV; and IVD and medical device clinical investigation management under ISO 14155.
Common questions.
Questions not addressed here can be directed through the contact form below.
Enova is a clinical research consulting firm delivering senior-led clinical monitoring, GxP auditing, and quality oversight across global development programs. Quality by Design and Quality Risk Management are the methodological foundation behind how that work gets done. The firm also takes on study rescue and remediation engagements where monitoring has collapsed, CAPA or eTMF remediation is needed, or trial conduct requires urgent stabilization.
Quality by Design identifies critical-to-quality factors and builds control strategies into the trial prospectively, before the first site is activated. Quality Risk Management is the ongoing oversight engine that monitors whether those controls are holding throughout the study lifecycle using KRIs, risk registers, and deviation trend analysis. One sets the quality targets. The other monitors them. Together they form a closed loop.
A study rescue engagement is a structured, time-sensitive intervention for programs where quality has deteriorated to the point that trial conduct, regulatory compliance, or inspection readiness is at risk. Common scenarios include collapsed monitoring programs, aging CAPA backlogs, eTMF gaps ahead of submission, sponsor and CRO relationship breakdowns, and studies approaching a health authority inspection without adequate preparation. Enova assesses, triages, and executes a sequenced remediation plan with senior-level accountability throughout.
Yes. Enova conducts GCP, GLP, and GCLP audits against FDA requirements, ICH-GCP guidelines, and applicable global standards, with attention to documentation quality, audit trail integrity, deviation log management, and inspection preparedness. Audit findings feed the QRM framework as governance inputs, not just deficiency lists.
Yes. Pharmacovigilance support includes SAE and SUSAR reporting oversight, safety signal monitoring, safety data reconciliation, and alignment with sponsor pharmacovigilance systems and applicable regulatory reporting timelines under FDA and ICH guidelines.
Yes. Capabilities include investigational product accountability and chain of custody governance, pharmacy coordination, device accountability logs, lab kit design and management, central and local lab oversight, specimen handling logistics, and lab manual development. These are core clinical operations functions, not peripheral tasks.
Yes. Inspection readiness at Enova is a continuous state, not a pre-inspection sprint. Support includes systematic eTMF review, ISF assessment, SOP gap analysis, CAPA effectiveness evaluation, audit trail analysis, deviation log review, and team preparation for regulatory inspection conduct. The goal is that an inspection can happen at any point without a fire drill.
Yes. Enova provides clinical operations and quality support for IVD and medical device studies under ISO 14155 and applicable FDA guidance, including site management, device accountability, safety data oversight, performance documentation, and approval readiness. GxP principles and QRM methodology are applied to device-specific risk profiles and regulatory requirements.
Engagements are available on project, retainer, or embedded FSP models. 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.
Yes. Enova has specific experience supporting early-stage biotech and medtech companies establishing quality infrastructure, developing SOPs, and preparing for first regulatory submissions or audits. Applying QbD principles at the start of a program is substantially more effective than remediating quality gaps under regulatory pressure.
Start the conversation.
Enova reviews every inquiry at the principal level and responds within one business day. Whether you need a monitoring gap filled mid-study, are preparing for a health authority inspection, working through a CAPA or eTMF remediation, managing a sponsor and CRO relationship breakdown, building quality infrastructure from scratch, or evaluating a longer-term FSP relationship, the first step is a direct conversation about what your program actually requires.
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