Clinical research quality
Compliance. Integrity.
AMiK is an independent GCP audit and clinical quality consulting practice.
We support sponsors, CROs, and research sites in building compliant,
inspection-ready systems aligned with ICH E6(R3), EMA, FDA BIMO,
and national regulatory expectations.
Our approach focuses on documentation integrity, operational clarity, and long-term quality system maturity.
Our Team.
The AMiK team is composed of experienced GCP auditors, clinical quality leaders, operational strategists, and regulatory readiness experts.
We bring hands-on experience across global sponsor, CRO, investigator site, and regulatory environments, enabling us to provide practical, actionable support that strengthens oversight, compliance, and operational execution.
Our services
We support sponsors, CROs, and research sites in strengthening clinical research quality through independent auditing, inspection readiness, quality system development, and targeted professional training.
We conduct independent audits of Sponsors, CROs, Research sites, and vendors to evaluate compliance with ICH E6(R3), EMA, FDA BIMO, MHRA, and local regulatory expectation.
Our assessments examinate Protocol execution and governance adherence, documentation quality, data integrity, participant safety protection, and TMF/eTMF completeness.
Observations are risk-ranked and supported with actionable CAPA guidance to build lasting quality maturity, not just short fixes.
Regulatory inspection readiness & oversight
We support Sponsors, CROs, and Research Sites in preparing for regulatory inspections by EMA, FDA, MHRA, NCAs, and Health Authorities worldwide.
Our approach focuses on operational clarity, documentation integrity, and confident team communication.
Beyond checklists, we coach staff, simulate live-room interactions, and strengthen evidence trails for protocol deviations, safety, IMP, TMF/ISF components, and data integrity - delivering confidence, consistency, and controlled narratives on inspection day.
The outcome is not just inspection day preparedness, but a sustainable culture of transparency, ownership, and quality maturity across your research operation.
Training & professional development
We deliver targeted training programs that strengthen operational execution, reinforce regulatory expectations, and build quality-driven competencies across research teams. Our curriculum is designed to address real-world study challenges, not just theoretical guidance.
Programs include:
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ICH E6(R3), EMA, FDA BIMO, MHRA, and national GCP principles
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Audit and inspection conduct and communication
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TMF/eTMF quality, metadata stewardship, and essential documents integrity
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SOP/WI compliance and deviation prevention
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CAPA development, effectiveness verification, and issue management lifecycle
Trainings are delivered live (remote or on-site) with practical exercises, scenario-based discussions, and reusable learning materials — enabling teams to apply knowledge immediately in study operations.
QMS development & advisory
We design, enhance, and optimize clinical quality management systems (QMS) that are scalable, inspection-ready, and aligned with international standards and your operational realities. Our support spans governance frameworks, SOP/WI architecture, roles and responsibilities mapping, oversight models, risk-based quality management (RBQM), and vendor / site engagement pathways.
We collaborate with leadership and study operations teams to establish clear accountability, decision-making channels, documentation integrity, and sustainable quality performance indicators (KPI). Our advisory approach emphasizes practicality and adoption — not theoretical templates that fail in real-world use.
The result is a QMS that strengthens operational confidence, improves inspection outcomes, and supports long-term organizational growth and scientific credibility.
Analytics
Turn your data
into actionable intelligence
We help organizations analyze, visualize, and automate clinical quality operations — enabling proactive risk management, real-time oversight, and evidence-based decision-making.
We enhance the integrity, reliability, and efficiency of clinical research by integrating independent oversight, regulatory inspection readiness, and data-driven quality improvement.
Our work empowers sponsors, CROs, and research sites to operate with clarity, accountability, and sustained compliance — not only for inspection day, but every day.
Let analytics strengthen quality, integrity & decision-making
We help organizations convert operational data into actionable intelligence.
Our analytics and automation solutions enhance oversight, accelerate performance, and support regulatory defensibility across clinical development programs.
Quality
visualizations
We transform operational and quality data into clear, decision-ready insights.
Dashboards and reports highlight performance trends, risk indicators, and quality maturity to support governance, oversight, and continuous improvement.
Workflow
automation
We automate key oversight workflows across eTMF, CTMS, and quality systems to reduce manual burden and improve traceability.
Automations support consistent execution and operational efficiency across
study teams.
Real-time
dashboards
Interactive dashboards provide continuous monitoring of clinical quality performance.
We integrate TMF, monitoring, audit, and CAPA data to detect emerging issues early and guide proactive intervention.
Compliance
tracking system
Digital CAPA and inspection readiness systems ensure accountability, traceability, and sustained quality improvement.
Our solutions support CAPA lifecycle control, audit defense documentation, and inspection preparation.
Trusted Quality Experience
15+
Years in
Clinical Quality
Research & Quality Leadership
50+
Clinical Studies Supported
Global, Multi-center & Local Trials
10+
Therapeutic Areas Covered
Oncology, Rare & Complex Diseases
25+
Regulatory Frameworks & Standards
ICH E6(R3), EMA, FDA BIMO, MHRA, WHO, GDPR
Our Partners
Request consultation
AMiK — Audit & Consulting for Clinical Research
Ukraine / EU — remote & on-site support
