Clinical Research Services
Transforming Clinical Insights into Real-World Impact
MediCozum is a leading contract research organization (CRO), providing the full range of clinical trial services to pharmaceutical, Biotech, medical device and diagnostic companies for all trial phases, BA/BE studies and post-marketing trials. Our end-to-end solutions and customized strategies cover every aspect of clinical research. Our experienced team takes pride in its ability to consult and plan for every step of developing and testing medical therapies.
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.
1. MEDICAL WRITING SERVICES
- • Protocol Writing
- • Investigator’s Brochure
- • Patient Narratives
- • Clinical Study Report/eCTD
- • Informed Consent Forms
- • Clinical and Nonclinical Summaries
- • Drug Monograph
- • Regulatory
2. Site Management & Trial Monitoring
MediCozum provides comprehensive site support services to ensure successful execution and oversight:
- • Site selection, qualification, and initiation
- • Regular on-site and remote monitoring visits for data integrity and protocol adherence
- • Training site staff in GCP, safety reporting, and documentation practices
- • Ensuring timely enrollment, retention, and query resolution Our trained clinical research associates (CRAs) and project managers coordinate across stakeholders to maintain operational excellence.
3. Ethics & Regulatory Documentation
Navigating regulatory landscapes can be complex—MediCozum simplifies it:
- • Preparation and submission of Institutional Ethics Committee (IEC) and Regulatory Authority applications
- • Drafting of Informed Consent Documents (ICDs) and Investigator Brochures
- • Ongoing amendment handling, SAE reporting, and compliance tracking We ensure that all research is conducted with transparency, patient protection, and regulatory adherence at every level.
4. CLINICAL DATA MANAGEMENT SERVICES
- • Database design, development, and maintenance
- • Data entry, data verification, and data cleaning
- • Medical coding setup and implementation
- • Case Report Form (CRF) design with SDTM implementation guides
- • Electronic data integration
- • External data import and reconciliation
- • Medical coding using WHODD & MedDRA dictionaries
- • Serious adverse event (SAE) reconciliation
- • Management and integration of local laboratory reference ranges with CRF data
- • Integration, verification, and reconciliation of external/TPV data
- • EDC selection and end-user training
- • Database lock and archival
- • Database transfer
5. Pharmacovigilance & Safety Monitoring
Patient safety is paramount to every study.
- • Adverse Event (AE)/Serious Adverse Event (SAE) collection, assessment, and reporting
- • Case Distributions to Ethics Committees, IRBs, Licensee Partners
- • Clinical Study Report (CSR)
- • Periodic Safety Update Report (PSUR)
- • Individual Case Safety Report
- • Global Literature Search and Management
- • Aggregate Safety Report
Our pharmacovigilance experts work in line with global regulatory guidelines (e.g., ICH E2E, GVP modules, CDSCO, MHRA).