Stay Inspection-Ready. Prevent Findings. Protect Your Trial

HolistiNova Research helps biotech sponsors and CROs strengthen sponsor oversight, improve GCP compliance, and maintain inspection-ready clinical trial operations through risk-based quality management and independent QA support.

We are one of the few boutique QA firms operating natively under ICH E6(R3) — the revised GCP standard effective July 2025, not retrofitting legacy processes to meet new requirements. If your trials aren't aligned yet, the gap is already growing.

We also provide short-term, embedded clinical quality and sponsor oversight support for organizations experiencing staffing shortages, transitions, or temporary coverage needs.

Built on real-world clinical quality leadership, focused on preventing findings, strengthening oversight evidence, and protecting trial integrity.

Schedule a Free Quality Readiness Call

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.

Clinical Trial Compliance Is Getting Harder

  • Increasing regulatory expectations

  • Unexpected inspection findings

  • Oversight documentation gaps

  • TMF quality issues

  • Reactive CAPAs

You Don’t Have to Navigate This Alone

We provide Sponsor Oversight and Quality Support you can scale.

HolistiNova Research is a boutique clinical quality and inspection-readiness partner helping sponsors and CROs strengthen sponsor oversight, improve GCP compliance, and maintain inspection-ready operations.

ASSESS. STRENGTHEN. MAINTAIN

Need Temporary Clinical Quality Support?

If your team is short-staffed, in transition, or facing hiring delays, HolistiNova can step in quickly with experienced QA and sponsor oversight professionals to keep your trials compliant and inspection-ready.

✔ No recruitment needed — we hit the ground running.

✔ Experienced QA professionals embedded directly into your team.
✔ Flexible monthly support without long-term contracts or benefits overhead.

We got you covered, Talk to us
  • Business professionals reviewing documents at a conference table in an office setting.

    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

  • Five people having a meeting in a glass-walled conference room with coffee cups, laptops, and a whiteboard.

    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

  • Person checking off items on a digital checklist with a pen and laptop.

    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

  • Flexible QA & Sponsor Oversight Coverage (Interim / Fractional Support)

    Short-term, experienced quality Assurance and sponsor oversight professionals embedded into your team to cover staffing gaps caused by leave, turnover, or transitions…without the cost and delay of hiring.

    Interim sponsor oversight support

    Temporary QA leadership

    TMF quality review & remediation

    CAPA development & tracking

    Inspection readiness support

Why HolistiNova?

A professional woman in a navy blazer and white shirt smiling in front of a window with an urban background.

Founded by Dr. Wijdan Suliman, MD, MHA

Dr. Suliman brings a credential set that is rare in clinical QA: a medical degree, a Master's in Health Administration, and deep hands-on expertise in GCP compliance, inspection readiness, and risk-based quality management.

Most QA consultants come from regulatory or administrative backgrounds. Dr. Suliman understands trials from the inside — as a clinician, as an administrator, and as a quality professional. That combination means HolistiNova doesn't just find gaps. We understand why they exist and how to fix them durably.

Credentials: MD · MHA · APMMC · GCP Certified · ICH E6(R3) · Inspection Readiness · RBQM

HolistiNova works with emerging sponsors, CROs, and innovative trial platforms, including decentralized and integrative medicine research, where traditional QA firms have limited fluency.

“Our mission is to support ethics, quality, and excellence at every stage of clinical development.”

Lets talk Quality

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?

  • Clear sponsor oversight evidence

  • Strong inspection outcomes

  • Reduced compliance risk

  • Confident teams

Schedule a Free Quality Readiness Call

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.

Schedule a Free Quality Readiness Call