Sponsor Oversight & Quality Management for Clinical Trials
HolistiNova partners with biotech sponsors and CROs to stay inspection-ready through risk-based oversight, GCP audits, TMF quality review, and CAPA management.
Built on real-world clinical quality leadership …focused on preventing findings, strengthening oversight evidence, and protecting trial integrity.
GCP • ICH E6(R2)/E6(R3) aligned
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Risk-Based Quality Management
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TMF QM
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CAPA Management
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Vendor Oversight
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GCP • ICH E6(R2)/E6(R3) aligned 〰️ Risk-Based Quality Management 〰️ TMF QM 〰️ CAPA Management 〰️ Vendor Oversight 〰️
Clinical trials don’t fail in audits; they fail in the gaps before the audit.
Sponsors and CROs often struggle with:
unclear oversight documentation
inconsistent TMF quality
delayed CAPAs and repeat deviations
vendor oversight that isn’t inspection-ready
quality systems that don’t scale with growth
We help you close these gaps early — and stay ready at all times.
We provide Sponsor Oversight and Quality Support you can scale.
HolistiNova is a boutique Quality partner built for fast-moving teams. We help you:
✅ reduce compliance risk
✅ strengthen oversight evidence
✅ maintain audit readiness across your trial portfolio
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Sponsor Oversight Retainers
Ongoing Quality Oversight, Built for Inspection Readiness
Sponsor oversight documentation support
Quality metrics & trending
Vendor qualification & oversight review
CAPA oversight and escalation support
RBQM strategy refinement
Best for: Sponsors & CROs managing multiple studies/vendors
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Audit Readiness & Inspection Preparation
Be ready before the inspection notice arrives
Mock FDA inspection readiness review
TMF completeness & QC assessment
Gap analysis + remediation plan
CAPA and deviation health check
Staff readiness coaching & audit support
Best for: Phase II/III programs, rapid growth, pre-IPO
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Quality Systems & Documentation
Build a QMS that supports scale
SOP development and implementation
QMP / Quality manual setup
Risk register framework (RBQM)
Vendor qualification packages
Training documentation and compliance workflow
Best for: CRO startups, emerging sponsors, new programs
Why HolistiNova?
Founded by Dr. Wijdan Suliman, MD, MHA, APMMC
HolistiNova combines deep medical expertise with advanced training in Clinical Research, GCP compliance, and Research Quality Management.
We offer responsive, rigorous QA services tailored for today’s evolving clinical research landscape.
Rapid onboarding with clear deliverables
Inspection-ready documentation from day one
Sponsor mindset: oversight and evidence come first
Risk-based approach to focus on what matters most
Flexible support: per-project or retainer
“Our mission is to support ethics, quality, and excellence at every stage of clinical development.”
WHO WE SERVE
Holistic & Integrative Medicine Trials
CROs scaling operations
Emerging biotech sponsors
Academic & Clinical teams preparing for inspection readiness
What does success look like?
Oversight documentation that holds up under inspection
Cleaner TMFs with fewer missing artifacts
CAPAs that close on time and prevent recurrence
Reduced deviation trends through risk controls
A scalable quality system your team can actually maintain
Let’s make your trials inspection-ready… and keep them that way.
If you need a Quality partner who can step in fast, identify the gaps, and build audit-ready oversight systems without slowing your operations, we should talk.