Data Management
Our data management services ensure the accurate, compliant, and efficient handling of clinical trial data from collection through analysis. We provide full support, from designing case report forms to database development and ongoing data validation, ensuring data integrity and regulatory compliance.
- Paper CRF and eCRF design and planning
We design both paper and electronic Case Report Forms (CRF/eCRF) tailored to your study’s needs. Our CRFs are structured to capture relevant data efficiently and accurately, supporting seamless data collection and compliance with regulatory standards.
- Development of CRF completion guidelines
Our team develops detailed CRF completion guidelines to provide investigators and site staff with clear instructions on how to properly enter data. These guidelines ensure consistent and accurate data entry across all study sites.
- Development of Data Management Plan
We create comprehensive Data Management Plans (DMPs) that outline the processes and procedures for handling study data. These plans ensure high data quality, compliance with regulatory standards, and consistency throughout the study.
- Database development, validation, and maintenance
We develop, validate, and maintain secure clinical trial databases that meet industry standards and regulatory requirements. Our databases are designed to support efficient data entry, validation, and ongoing monitoring throughout the trial.
- Data edit check planning and management
Our team plans and manages data edit checks to identify discrepancies, missing data, or outliers. This ensures the integrity and reliability of trial data before it is analyzed, minimizing errors and improving data quality.
- Data validation and query management
We perform rigorous data validation and manage queries to ensure data accuracy and completeness. Our approach resolves inconsistencies in real-time, helping to maintain clean datasets that are ready for analysis.
- Medical coding
We offer expert medical coding services to standardize data across clinical trials. Using recognized coding systems, we ensure that adverse events, medications, and diagnoses are consistently categorized.
- Status report preparation
Our team provides regular status reports that track data management progress, highlighting key metrics and any issues. These reports keep sponsors informed and ensure transparency throughout the data collection process.
- Data Monitoring Committee services
We offer Data Monitoring Committee (DMC) services to ensure the safety and efficacy of clinical trials. Our DMCs review interim data and provide independent oversight, ensuring the trial’s integrity and safety are maintained throughout its duration.