Independent GCP Quality Assurance

Ensuring Excellence in
Clinical Research

Partner with us to achieve the highest standards of data quality and patient protection across all stages of your clinical trials.

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What We Offer

Our Services

Comprehensive GCP Quality Assurance solutions designed to protect patient safety and ensure data integrity throughout your clinical trials.

01

GCP Consultation

Compliance and quality assurance support ensuring studies adhere to ICH-GCP standards. Including CAPA development, audit findings resolution, and staff training.

Elevate Your Clinical Trials

Are you seeking not just compliance, but a gold standard of quality and integrity for your clinical research?

We offer specialized Good Clinical Practice (GCP) Consultation services designed to transform your operations from simply meeting regulations to setting a benchmark for ethical and scientific excellence in human subject research. We provide robust, end-to-end compliance and quality assurance support for all phases of clinical trials.

Unwavering Participant Safety: Guaranteeing the rights, well-being, and safety of every human subject enrolled in your trials.
Data Integrity & Reliability: Maintaining the highest standards of data quality, ensuring your results are credible, verifiable, and submission-ready.
Global Regulatory Confidence: Equipping you to successfully navigate the complex regulatory landscapes across major global markets.

What we offer:

  • Proactive CAPA Development & Implementation
  • Expert Response to Audit & Inspection Findings
  • Bespoke Staff Training & Competency Development
  • SOP Optimization, Vendor Qualification, Site Monitoring Excellence
02

Audit Activities

End-to-end audit process covering Investigator Sites, Processes/Systems, Vendors audits and management, and Clinical Documentation.

Strategic Quality Assurance

In the complex landscape of clinical research, certainty is your greatest asset.

We offer Strategic Audit Activities and Comprehensive Assessments—a specialized service designed to provide you with complete, end-to-end oversight and risk mitigation for every critical facet of your clinical program. Our methodology is rigorous, proactive, and focused on delivering actionable insights.

Risk Reduction: Proactively identify and resolve compliance risks that could lead to costly delays or regulatory sanctions.
Inspection Readiness: Build an inherently strong quality system that ensures your organization is prepared for regulatory inspections at any time.
Strategic Insight: Receive clear, prioritized recommendations that support long-term quality improvement and operational excellence.

What we offer:

  • Investigator Site Audits
  • Process and System Assessments
  • Vendor Audits and Management
  • Clinical Documentation Audits (TMF/eTMF)
  • Specialized Audits (Pharmacovigilance, Data Management, Bio-statistics)
03

Inspection Readiness

Support to ensure inspection-ready state at all times. Mock inspections, staff interview preparations, and comprehensive training programs.

Achieve Continuous Inspection Readiness

Is your clinical organization genuinely prepared to face a regulatory inspection at a moment's notice?

We offer premium Inspection Readiness Consultation Services designed to eliminate inspection-related anxiety and establish an "always-ready" status across your entire clinical trial portfolio. Our support model covers every critical stage of the inspection lifecycle.

Maximized Confidence: Eliminate the stress and uncertainty associated with looming inspections.
Minimized Risk: Proactively manage risks that could lead to negative findings or clinical holds.
Time & Resource Efficiency: Focus your internal teams on core research while we handle the complex readiness preparation.

What we offer:

  • High-Fidelity Mock Inspections (FDA, EMA style)
  • Staff Interview Mastery & Role-Playing
  • TMF/eTMF Review and Organization
  • Live Inspection Guidance (Remote or On-site)
  • Post-Inspection CAPA Strategy & Response Drafting
04

QMS Support

Preparation and review of SOPs, Work Instructions, and templates. Gap analysis and temporary QA Department management.

Strategic Quality Management System

Is your Quality Management System merely functional, or is it a powerful, strategic engine driving efficiency, compliance, and growth?

We offer elite QMS Support designed to elevate your quality infrastructure from a necessary burden into a clear competitive advantage. Our service provides flexible, expert assistance that perfectly aligns your quality framework with your business objectives.

Documentation Mastery: Expert preparation, review, or update of SOPs, Work Instructions, templates, and policies ensuring clarity and regulatory alignment.
Gap Analysis & Remediation: Rigorous assessments against regulatory expectations (ICH-GCP, GVP, GLP) with prioritized remediation roadmaps.
Operational Flexibility: Interim QA leadership and talent acquisition support for growing organizations.

What we offer:

  • SOP, Work Instruction & Template Development
  • Comprehensive Gap Analysis
  • QMS Optimization and Streamlining
  • Executional QA Leadership (Interim/Project-Based)
  • Talent Acquisition Support
05

Tailored Solutions

Custom services designed for your specific needs. Share your requirements, and we will develop a personalized solution.

Your Vision, Our Tailored Solution

We understand that quality needs are rarely standard.

If your challenge falls outside a conventional service description, we invite you to reach out. Tell us your specific need—whether it's preparing for a major system migration, handling a complex regulatory query, or rapid scale-up—and we will architect an innovative, custom solution utilizing our deep regulatory and operational expertise.

Fully Customized: Solutions designed specifically around your unique challenges and organizational needs.
Expert-Driven: Leverage our deep regulatory and operational expertise for any quality challenge.
Flexible Engagement: Work with us on your terms—project-based, ongoing support, or anything in between.

What we offer:

  • Major System Migration Support
  • Complex Regulatory Query Handling
  • Rapid Scale-up Assistance
  • Custom Quality Solutions

About

Meet Your QA Partner

Lucas Dzioba - GCP Quality Assurance Professional

Lucas Dzioba

GCP Quality Assurance Expert

With over 18 years of experience working on both sides of the regulatory fence, I bring a unique perspective that combines scientific rigor with practical QA expertise.

As a biologist and pharmacist by education, I understand the science behind clinical research. This foundation allows me to deliver quality assurance that truly enhances the day-to-day conduct of your trials.

18+ Years Experience
10+ QA Team Members Led
2 Regulatory Perspectives

Areas of Expertise

Quality Management Systems (QMS) Development
Internal & External Audit Leadership
Regulatory Authority Inspections
CAPA & Deviation Management
Vendor Management & Assessment
GCP Training & Education

Get in Touch

Let's Start a Conversation

Ready to elevate your clinical trial quality assurance? I'm here to help you achieve compliance excellence and protect patient safety.

Email contact@dzioba.online
Phone +48 507 173 676
LinkedIn Lucas Dzioba, PhD, MRQA
Availability Remote & On-site Worldwide

Ready to Connect?

Share your quality assurance challenges and let's discuss how we can work together to achieve your goals.

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