Clinical trial data requires quality monitoring from the collection stage, and we establish a logical data flow based on the protocol and reflect the interrelationships between variables and data integrity in advance through eCRF (electronic Case Report Form) design. The eCRF is designed with both medical relevance and statistical analysis requirements in mind, integrating quality control functions such as prevention of missing mandatory fields, standardized data formats, and automated verification logic.

This reduces the likelihood of errors during later monitoring and data-cleansing phases. From the initial design phase, we ensure both user-friendliness and accuracy, while the finalized and approved eCRF is version-controlled in accordance with SOPs and fully complies with regulatory requirements.

Once clinical trial data collection begins, we operate a system that continuously checks for data entry errors, missing values, and illogical entries in real time. Error management for high-risk variables is conducted through a combination of automated validation logic and manual review.
Query management is carried out in collaboration with monitoring staff, ensuring that scientific judgment reflects on-site circumstances.

This approach reduces unnecessary queries, minimizes investigator workload. We manage clinical trial data in compliance with the data integrity principles required by regulatory agencies (ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, and more).

Database Lock (DB Lock) is not merely a technical system lock, but a critical milestone signifying that the entire data set of a clinical trial is suitable for statistical analysis and meets the quality standards required for submission to regulatory agencies.

Prior to DB Lock, we conduct a comprehensive data‑cleansing process to review the consistency and completeness of all data. the risk of errors is minimized and data consistency is ensured through prompt and accurate responses to DCFs (Data Clarification Forms), review and resolution of serious adverse events (SAEs), and re-verification procedures in accordance with predefined validation plans for key evaluation variables.

Following DB Lock, we collaborate closely with the statistical analysis team to generate analysis‑ready datasets, manage documentation versions, and ensure seamless progression to subsequent analyses. All datasets are maintained in compliance with the Statistical Analysis Plan (SAP) and relevant regulatory authority requirements.