We provide end-to-end electronic data capture (EDC) and clinical data management solutions to ensure the accuracy, integrity, and security of study data, using a 21 CFR Part 11 (Code of Federal Regulations)–compliant EDC system. Our expertise spans database design, CRF/eCRF (case report form/electronic case report form) development, validation, ETL (extraction, transformation, and loading), query management, discrepancy resolution, and data cleaning. We incorporate advanced randomization techniques, including stratified and block randomization, to ensure unbiased subject allocation.
Our EDC system and processes comply with global data protection and privacy regulations, including HIPAA (Health Insurance Portability and Accountability Act, US law on health data privacy and security) and GDPR (General Data Protection Regulation, EU regulation on data protection and privacy), ensuring the secure handling of sensitive patient data. Using advanced data validation tools, edit checks, and audit trails, we enhance data reliability while adhering to industry standards such as CDISC (Clinical Data Interchange Standards Consortium), SDTM (Study Data Tabulation Model, a CDISC standard for organizing clinical trial data), and ADaM (Analysis Data Model, a CDISC standard for datasets designed for statistical analysis). Our streamlined workflows optimize data flow, improve efficiency, and accelerate study outcomes while maintaining regulatory compliance and data integrity.
At Turacoz, we are committed to delivering reliable, high-quality data that power informed decision-making in clinical trials. Our EDC and clinical data management services provide the accuracy, compliance, and efficiency needed to ensure your study's success. Contact us today to learn how our tailored solutions can support your clinical trial journey.
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