EDC & Clinical Data Management

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 compliant EDC system. Our expertise spans database design, CRF/eCRF development, validation, data extraction, transformation, and loading (ETL), 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 and GDPR, ensuring 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, SDTM, and ADaM. Our streamlined workflows optimize data flow, improve efficiency, and accelerate study outcomes while maintaining regulatory and data integrity.

Our EDC & Clinical Data Management Services Include

Comprehensive Data Management:

  • End-to-end solutions ensuring accuracy, integrity, and security of study data using a 21 CFR Part 11 compliant EDC system.

Database & CRF/eCRF Development:

  • Expert design, validation, and implementation of study databases and electronic case report forms.

Data Processing & Quality Control:

  • Advanced ETL (Extraction, Transformation, and Loading), query management, discrepancy resolution, and data cleaning.

Randomization & Bias Control:

  • Implementation of stratified and block randomization techniques for unbiased subject allocation.

Regulatory Compliance & Security:

  • Adherence to HIPAA, GDPR, and global data privacy regulations for secure patient data handling.

Industry Standards & Validation:

  • Integration of CDISC, SDTM, and ADaM standards with robust validation tools, edit checks, and audit trails.

Optimized Data Workflows:

  • Streamlined processes to enhance efficiency, accelerate study timelines, and maintain data integrity.
     

 

Partner with Turacoz

At Turacoz, we are committed to delivering reliable, high-quality data that powers 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 more about how our tailored solutions can support your clinical trial journey.

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Partner with Turacoz to bring science to life through strategic and evidence- based communication.

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