Medicozum – Clinical Research Services
(A Unit of Medicozum)

Empowering Innovation. Ensuring Compliance. Advancing Global Health

Your Trusted Global CRO Partner in Research, Compliance & Innovation

Medicozum – Clinical Research Services (A Unit of Medicozum Limited) is a global Clinical Research Organization (CRO), headquartered in the United Kingdom. MediÇözüm derived from two words— “Medi” (medical) and “Çözüm” (a Turkish word meaning solution)—is an integrated healthcare and research organization led by medical professionals, dedicated to excellence in clinical research, patient care, education, and innovation.

Founded in 2023 and driven by scientific expertise and operational excellence our mission is to improve the health of millions of people worldwide through clinical research supported by global service delivery, world-class scientific leadership, and therapeutic specialties. As a trusted clinical research and healthcare innovation partner, we offer a full spectrum of end-to-end research services to support investigators, academic institutions, hospitals, pharmaceutical companies, and CROs across all phases of clinical development.

Our services are designed to ensure scientific integrity, regulatory compliance, and patient safety, while maintaining cost-efficiency and timely delivery. From protocol design to publication, we work collaboratively to convert complex data into actionable, real-world evidence.

Explore Our Core Services

Clinical Trial Management (Phase I–IV)

At Medicozum – Clinical Research Services, we provide comprehensive management of clinical trials from Phase I to Phase IV. Our team works closely with sponsors to design scientifically sound and ethically robust studies that are aligned with both regulatory expectations and therapeutic objectives. We conduct in-depth feasibility assessments and carefully select trial sites and investigators to ensure access to the right patient populations, efficient study execution, and high-quality data generation.

From early-phase safety and pharmacokinetic trials to large-scale, multicenter Phase III and post-marketing Phase IV studies, we deliver operational excellence that supports timely approvals and successful commercialization of therapies.

Regulatory Affairs

Our Regulatory Affairs team provides end-to-end support in navigating the complex global regulatory environment. From the preparation of Investigational New Drug (IND) applications to New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and post-marketing submissions, we ensure accuracy, timeliness, and compliance at every step. We maintain strong relationships with leading health authorities such as the FDA, EMA, MHRA, and DCGI, facilitating effective communication and faster approvals. Our experts guide sponsors in strategic planning, dossier preparation, and lifecycle management, helping them overcome regulatory hurdles and achieve successful outcomes in multiple jurisdictions.

Pharmacovigilance & Drug Safety

Drug safety is at the heart of our operations. Our Pharmacovigilance team ensures that patient well-being and product safety remain top priorities throughout the drug development lifecycle. We manage the collection, assessment, and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) with precision and efficiency. Our global safety database supports seamless case management and regulatory submissions across multiple regions. We also design and implement Risk Management Plans (RMPs) and perform ongoing signal detection, aggregate safety analysis, and benefit–risk evaluations. By ensuring compliance with international pharmacovigilance requirements, we provide sponsors with the confidence that their products are monitored with the highest degree of responsibility.

Medical Writing & Documentation

Clear, accurate, and regulatory-compliant documentation is essential for the success of any clinical program. Our Medical Writing team combines scientific expertise with communication excellence to produce high-quality documents for every stage of drug development. We specialize in authoring clinical trial protocols, Investigator’s Brochures (IB), and Clinical Study Reports (CSR/eCTD), ensuring they meet regulatory expectations. Our writers also prepare patient-informed consent forms, safety narratives, and summaries for both clinical and nonclinical studies. In addition, we support the development of regulatory dossiers, drug monographs, and scientific publications. By transforming complex data into precise and reader-friendly documentation, we bridge the gap between research findings and regulatory approvals.

Data Management & Biostatistics

Our Data Management and Biostatistics team ensures the reliability and accuracy of study outcomes through advanced data-handling practices. We design Case Report Forms (CRFs) and implement secure Electronic Data Capture (EDC) systems tailored to each trial’s requirements. Rigorous processes for data validation, query management, and cleaning guarantee data integrity and compliance with CDISC and global data standards. Our biostatistics experts provide end-to-end statistical support, from study design and sample size calculation to interim analyses and final study reporting. We also leverage modern tools for real-world evidence (RWE) generation, predictive modeling, and advanced data visualization, enabling sponsors to make informed decisions based on robust statistical insights.

Quality Assurance (QA)

Quality is embedded in everything we do. Our Quality Assurance team maintains a comprehensive Quality Management System (QMS) that governs all processes within the organization. We conduct regular internal audits, risk-based monitoring, and readiness assessments to ensure compliance with regulatory expectations. Our team also prepares sponsors for inspections conducted by global authorities such as the FDA, EMA, and DCGI, ensuring that all documentation, processes, and trial sites are fully audit-ready. By implementing Corrective and Preventive Actions (CAPA) and developing Standard Operating Procedures (SOPs), we ensure a culture of continuous improvement and operational excellence across all projects.

Business Development & Partnerships

Our Business Development division focuses on building long-term, strategic partnerships with clients across the globe. By understanding the unique requirements of each partner, we provide tailored solutions that align with their timelines, budgets, and development goals. We support sponsors with proposal development, contract negotiation, and project planning, ensuring a smooth and transparent engagement process. In addition, our team develops customized marketing strategies to highlight our CRO capabilities and strengthen client relationships. With a client-centric approach, we aim to go beyond being a service provider, becoming a trusted extension of our partners’ research and development teams.

Chief Scientific Officer / Director of Research
Dr. Ishrat Rahman, Ph.D. SRPharmS. FHEA. MAPS.
United Kingdom
Email: [email protected] | [email protected]