Monitoring collapses. CAPAs age. Inspections arrive before programs are ready. Enova engages when the margin for error is narrow and the standard for delivery is not.
Enova Medical Group is a senior-led clinical research consulting firm focused on clinical monitoring, GxP auditing, quality oversight, and regulatory readiness across global development programs. Work is structured for direct execution, not layered through junior delivery models.
Engagements are grounded in Quality by Design and Quality Risk Management. Oversight is built into study execution, not applied after issues emerge. This approach prioritizes critical-to-quality factors, early signal detection, structured risk assessment, and alignment with regulatory expectations throughout the study lifecycle.
Enova supports biopharmaceutical, medical device, IVD, diagnostics, academic, and site-based research environments operating under FDA regulations, ICH-GCP, ISO 14155, ISO 9001, and other global frameworks.
Enova is engaged across ongoing programs, execution gaps, urgent backfill, audit readiness, monitoring consistency, CAPA remediation, documentation recovery, and programs requiring additional oversight to maintain quality and compliance.
Clinical programs create risk through execution drift, documentation gaps, site variability, and delayed escalation. Enova's work is structured to help teams identify issues earlier, maintain oversight discipline, and keep quality aligned with regulatory expectations.
Enova's practice areas are structured around senior-led execution, regulatory alignment, and quality oversight across the clinical trial lifecycle. Each engagement is scoped around defined deliverables, defensible documentation, and practical execution support.
Senior-led monitoring across study execution, site engagement, and issue escalation, aligned with protocol requirements and regulatory expectations.
Structured audit support and inspection readiness aligned with ICH-GCP, sponsor expectations, and global regulatory requirements.
Risk-based oversight designed to identify, assess, and address issues before they impact study execution or regulatory outcomes.
Focused intervention for studies requiring stabilization, correction, or increased oversight due to quality or execution gaps.
Operational expertise extends core delivery when organizations need deeper quality governance, regulated-system assurance, or structured remediation support without creating a competing services layer.
Executive-level quality leadership for organizations that need senior governance without a full-time internal quality executive. Engagements include quality strategy, QMS oversight, audit leadership, inspection readiness planning, and quality risk governance.
Risk-based CSA/CSV support aligned with FDA Computer Software Assurance expectations and 21 CFR Part 11. Coverage includes validation strategy, requirements traceability, test rationales, and oversight for eTMF, CTMS, EDC, and related regulated digital systems.
Structured gap analyses against applicable FDA, ICH-GCP, ISO, and sponsor requirements to identify control failures early. Findings are prioritized by compliance risk, translated into practical remediation actions, and tracked through closure-ready evidence.
Trusted across clinical research
Sponsors, CROs, device, diagnostics, academic, and clinical research organizations rely on senior-led oversight when execution, quality, and compliance need to stay aligned.
We operate within study execution, aligning monitoring, documentation, and quality oversight in real time.
Work is structured around Quality Risk Management, prioritizing early signal detection and proportionate oversight.
All activities are anchored to ICH-GCP and global regulatory expectations, ensuring inspection readiness is maintained continuously.
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.
Senior-led execution across clinical monitoring, auditing, and quality oversight.
"Quality that holds up under regulatory scrutiny is built into the study, not added during inspection preparation."
Dr. Rashad Lewis brings senior clinical monitoring, quality, and regulatory experience across clinical operations, GxP auditing, and risk-based oversight. His work focuses on helping sponsors, CROs, and life sciences organizations maintain execution discipline, inspection readiness, and practical quality alignment across complex development programs.
His background combines direct trial execution with regulatory and health science training. That perspective allows Enova to translate requirements into practical oversight, identify risk early, and guide teams through quality issues before they affect timelines or inspection readiness.
Experience includes GCP, GLP, and GCLP audit execution, SAE and SUSAR reporting oversight, IP and device accountability, lab coordination, RBQM strategy, KRI and KPI framework development, ICH Q9(R1)-aligned quality risk management, eTMF remediation, CAPA governance, Fractional Quality Leadership advisory support, CSA/CSV oversight, Regulatory Gap Analysis, and IVD and medical device clinical investigation management under ISO 14155.
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. When needed, this extends into Regulatory Gap Analysis and CSA/CSV-focused remediation planning.
Yes. Pharmacovigilance work 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 oversight for IVD and medical device studies under ISO 14155 and applicable FDA guidance, with emphasis on site governance, 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 with 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.
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.
We respond within one business day with direct follow-up from Enova leadership.
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