Quality & Compliance Oversight
Clinical Study Quality and Compliance Oversight Services ensure that clinical studies are conducted according to ICH Good Clinical Practice (GCP) guidelines, regulatory requirements, ethics committee requirements and protocol-defined standards. This service helps Sponsors avoid inspection findings, detect issues early and maintain high-quality data throughout the study lifecycle.
Confident Compliance Starts Here.
Our quality and compliance experts help you avoid delays, protect participants and meet every regulatory expectation before the audit or inspection begins.
Quality Management System Support
At ClinOps Specialists, we support Clients in building, and maintaining a fit for purpose Quality Management System (QMS) that ensures consistent, compliant and inspection-ready clinical study execution.
We understand that every organisation is different, so we tailor our QMS support to your size, structure and study complexity, whether you’re an emerging biotech or an established Sponsor.
Our approach focuses on embedding quality by design into your processes, so quality becomes proactive, not reactive. Our QMS support includes:
- Custom QMS framework development for clinical operations
- Hierarchy of quality documents (Policies, Standard Operating Procedures, Work Instructions)
- QMS governance structure (roles & responsibilities, review cycles, escalation paths)
- Documentation templates and version control strategy
- Integration with vendor oversight and risk-based quality processes (risk-based issue escalation procedures for deviations, vendor performance, quality events).
- Quality oversight tools (e.g., audit checklists, deviation trackers)
- Quality Issue and Corrective and Preventive Action (CAPA) processes
- Support for regulatory inspections and audits
We help you build a QMS that’s not only compliant, but practical, scalable and aligned with how your team works.
SOP Development, Review & Optimisation
At ClinOps Specialists, we support Sponsors in building and refining Standard Operating Procedures (SOPs) that form the foundation of compliant and efficient clinical study operations.
Whether you are a growing biotech in need of a complete SOP suite or an established company revising existing procedures, we provide fit for purpose SOP solutions that align with:
- ICH GCP Guidelines
- Local and Global Regulatory Requirements
- Current Industry Best Practices
Our team brings hands-on clinical operations experience and inspection-readiness insight to ensure that your SOPs are not only compliant but also practical and consistently applied. We develop clear, usable documentation that supports your team’s day-to-day work while also meeting the standards required for Sponsor audits and regulatory inspections.
SOP support services include:
- SOP gap assessments and audits
- Development of new SOPs tailored to your operations
- Review and refinement of existing SOPs
- Harmonisation across functions and vendors
- SOP templates and training support
Develop SOPs that support you, not constrain you.
Inspection Readiness Planning
At ClinOps Specialists, we prepare Sponsors and study teams to face audits and regulatory inspections with confidence.
We support inspection readiness from the earliest stages of study conduct, ensuring that documentation, processes and teams are aligned with GCP expectations, regulatory requirements and Sponsor standards.
Our proactive approach helps identify and resolve gaps early to reduce stress, prevent findings, and improve overall study quality.
Our Inspection Readiness Services Include:
- Risk-based inspection readiness plans
- Trial Master File health checks and reconciliation oversight
- Pre-inspection audits and mock interviews
- CAPA planning
- Team training and inspection coaching
Be ready!
GCP & Regulatory Alignment
At ClinOps Specialists, we ensure that every aspect of your clinical study is conducted in full alignment with ICH Good Clinical Practice (GCP) and applicable national and regional regulations.
We support Clients in embedding GCP principles into day-to-day operations, documentation, vendor oversight and site management, helping reduce compliance risks and build a strong foundation for inspection readiness. Whether you’re launching your first clinical study or managing a global portfolio, our team provides the insight and oversight needed to stay fully aligned with evolving regulatory expectations.
Our support includes:
- GCP compliance assessments and training
- Process and documentation review for regulatory alignment
- Integration of country-specific requirements
- Oversight of vendor and site adherence to GCP
- Risk mitigation strategies tied to compliance metrics
Be compliant!
Integration of Industry Best Practices
At ClinOps Specialists, we go beyond regulatory minimums to help Clients adopt industry best practices that elevate the quality, efficiency and credibility of their clinical study operations.
We stay informed of evolving guidance from regulators and help you integrate these standards into your workflows, SOPs and vendor oversight. Our practical, experience-driven approach ensures that best practices are not only adopted but also tailored to fit your operational model and resourcing.
Our best practice support includes:
- Assessment and benchmarking of current practices
- Tailored recommendations based on global standards
- Process updates aligned with e.g., ICH guidance
- Vendor and site alignment to shared quality expectations
- Ongoing updates as standards evolve
We help you lead with quality by aligning with what the best in the industry are already doing.
Issue Management & CAPA Oversight
- Tracking of protocol deviations, audit findings, and site-level issues
- Root cause analysis support
- Development, implementation, and follow-up of CAPAs
- Documentation of quality issues and resolutions
Things can go wrong – it’s how you deal with them that matters.
Quality Oversight Planning
- Development of study-specific Quality Management Plans
- Identification of critical-to-quality factors
- Risk assessment and control strategies
- Definition of quality Key Performance Indicators (KPIs) and metrics
- Alignment with ICH E6(R3), GCP, and Sponsor policies
Plan smart. Stay compliant.
Ongoing Quality Monitoring
- Quality oversight of clinical operations, monitoring, data management and safety activities
- Centralised or risk-based review of site performance, data integrity and documentation
- Deviation and non-compliance tracking
- Monitoring report review and compliance audits