QUALITY & COMPLIANCE
- Regulatory Compliance
- Local Compliance Expertise
- Data Integrity & Security
- Quality Assurance and Auditing
- Qualification and Training
Regulatory Compliance
MCT ensures full regulatory compliance across all clinical studies conducted in the Middle East, Africa, Pakistan, and the Eurasian Economic Union (EAEU).
Our operations are governed by robust Standard Operating Procedures (SOPs) and fully aligned with international Good Clinical Practice (GCP) guidelines. By combining global standards with strong local expertise, we help clients navigate complex and evolving regulatory environments—from initial submissions through site activation and close-out, including during regulatory inspections.
Key Strengths:
- Compliance: Adherence to international GCP and regional regulatory guidelines
- SOPs: Robust Standard Operating Procedures applied across all studies in line with international standards
- Regulatory Intelligence: Staying up to date with global regulatory developments and assessing their local impact
- Inspection Readiness: Managing client engagement with regulatory authorities and ensuring inspection readiness
- Proven Track Record: 100% of MCT studies completed with no critical regulatory findings.
Local Compliance Expertise
MCT’s regulatory specialists bring deep, country-specific experience to interpret local requirements, anticipate authority expectations, and help clients avoid delays or regulatory findings.
In regions where regulations are complex or not fully digitalized, our local experts provide practical, on-the-ground guidance to ensure studies progress efficiently and compliantly.
How We Support Local Compliance
- Regulatory Intelligence: Active monitoring of country-specific regulations
- Digital Database: Continuously updated for easy access to regulatory changes
- Tailored Planning: Compliance strategies customized for each country
- Proactive Risk Management: Early identification and mitigation of issues
- Site-Level Guidance: Ensuring compliance with local laws and GCP standards
- Global Coverage: Regulatory tracking across 50+ countries with a digital LMS Learning Management System
Data Integrity and Security
Protecting patient data and ensuring data integrity are fundamental to the quality of our clinical research. MCT ensures that all clinical trial data are accurate, secure, and fully auditable throughout the study lifecycle.
Our teams follow strict SOPs and receive continuous training programs, supported by industry-standard cybersecurity practices to guarantee confidentiality, traceability, and regulatory compliance.
Data protection measures include:
- Secure access controls and role-based permissions
- Data encryption and system-level safeguards
- Regular system audits and validation checks
- Backup procedures and breach escalation protocols
- Full audit trails to ensure traceability and integrity
Quality Assurance and Auditing
Quality assurance is at the core of everything MCT does. Our Quality Assurance (QA) framework supports continuous improvement, ensures regulatory compliance, and builds long-term trust with our clients.
An independent QA department reports directly to General Management, providing strong oversight through regular quality reviews at leadership level. This governance ensures that compliance decisions are consistent, well documented, and aligned with both local regulations and international standards.
Key Features of Our Quality Framework
- Robust Documentation: Quality documents maintained in line with regulatory and industry best practices
- Comprehensive Audits: Internal and contracted audits conducted across all study phases
- Sub-Contractor Assessment: All partners are verified to meet MCT’s high standards.
- Proven Client Trust: 85% repeat business rate and over 100 client audits completed successfully
Qualification and Training
At MCT, a well-trained team is essential to quality and compliance. All staff complete mandatory and regularly refreshed training in GCP, SOPs, and other regulatory requirements. This ensures commitment to quality, strengthens audit and inspection readiness, and supports high-quality, ethical clinical research.