Clinical research generates the evidence that determines how diseases progress, which treatments work, and what safety measures protect patients. Every approved medication, diagnostic test, and treatment protocol exists because systematic studies provided the data to support its use.
Our mission
This site covers the essential components of clinical research through organized information on core topics:
- Clinical trial design and methodology: study types, endpoints, statistical planning, and protocol development
- Data management and analysis: collection systems, statistical methods, data integrity, and reporting standards
- Regulatory affairs: FDA, EMA, ICH guidelines, IND/CTA submissions and approval processes, marketing authorizations, and post-market requirements
- Ethics and participant protection: IRB/IEC oversight, informed consent, vulnerable populations, and safety monitoring
- Quality control and assurance: GCP compliance, monitoring, audits, and corrective actions
- Safety management: adverse event reporting, risk assessment, and pharmacovigilance
- Site operations: investigator responsibilities, patient recruitment, study conduct, and documentation
The content focuses on established practices, regulatory requirements, and industry standards drawn from reputable sources. While we provide explanatory context and clarifications to improve understanding, each topic centers on authoritative definitions from regulatory bodies, professional organizations, and recognized industry standards. References to primary sources and official guidelines accompany the material.