Data Management

Clinical Data Management Services

At RAY CRO, we offer advanced Data Management services that ensure the accuracy, integrity, and security of your clinical trial data. Our solutions are continuously updated to incorporate the latest technological advancements and industry best practices.

Our comprehensive Data Management services include:

Data Management Planning

Customized Data Management Plans (DMPs) that provide a roadmap for data collection, validation, and reporting, tailored to the specific needs of your study.

CRF Design and Development

Development of user-friendly electronic Case Report Forms (eCRFs) and paper-based CRFs, optimized for precise and efficient data capture.

Database Design and Build

Cutting-edge database development with integrated validation checks to ensure data accuracy and adherence to study protocols.

Data Entry and Validation

High-quality data entry services with automated and manual validation processes to guarantee data consistency and reliability.

Data Cleaning and Query Management

Rigorous data cleaning processes and proactive query management to resolve discrepancies swiftly and maintain data accuracy.

Data Coding

Standardized coding of medical terms, adverse events, and medications using MedDRA, WHO Drug, and other industry-standard dictionaries.

Electronic Data Capture (EDC) Systems

Implementation and management of state-of-the-art EDC systems that streamline data collection, reduce errors, and facilitate real-time access to data.

Data Reconciliation

Ensuring consistency and accuracy between various data sources, including lab data, eCRFs, and external databases.

Risk-Based Monitoring (RBM) Support

Integration of risk-based monitoring strategies into data management processes to enhance data quality and trial efficiency.

Interim and Final Data Review

Continuous data review with real-time access to interim data reports, ensuring data readiness for statistical analysis and regulatory submission.

Database Lock and Archiving

Secure and compliant database lock procedures, followed by long-term archiving of study data for future reference and regulatory inspections.

Regulatory Compliance and Auditing

Adherence to global regulatory standards, including GCP, FDA, EMA, and other regional requirements, with full audit trails and data transparency.