Data Cleaning & Validation
Data cleaning and validation are not just technical processes – they are essential steps to ensure accurate results, regulatory approval, and patient safety. Without clean, validated data, even the most promising drug candidates can face delays, rejections, or safety concerns.At WEP, we specialize in rigorous data cleaning and validation, leveraging cutting-edge technology and expert-driven processes to deliver real-time, reliable and regulatory-compliant clinical data.
Our Approach to Data Cleaning & Validation
We employ a multi-layered quality control process, combining automation with expert review to maintain data integrity at every stage of your clinical trial.Establishing Data Cleaning Procedures
Procedures for identifying and addressing errors and inconsistencies are defined early as part of the Data Management Plan:- These procedures are tailored to the specifics of your trial and include details on components, data validation rules, edit checks, and query management processes.
Advanced Electronic Data Capture (EDC) Systems
We utilize industry-leading EDC platforms such as Medidata Rave, Merative Zelta, and REDCap Cloud with built-in field and form level checks to detect and correct errors in real time.Automated & Manual Validation Checks
We combine technology with expert review to ensure clean, accurate, and protocol-compliant data:- Real-time edit checks flag missing, out-of-range, or inconsistent data.
- Expert data managers review discrepancies to ensure compliance with study protocols.
- Query resolution workflows streamline communication with sites for fast data correction and resolution.
Medical & Statistical Oversight
We ensure that all clinical and statistical perspectives are considered throughout the data cleaning process:- Our medical monitors assess data for clinical plausibility, consistency, and potential for safety concerns.
- Statisticians analyze trends and outliers, to ensure robust data for regulatory submission.
Regulatory Compliance & Security
All data management processes are designed to meet global regulatory standards and ensure audit readiness:- Adherence to ICH-GCP, FDA, and EMA regulatory guidelines.
- Data validation aligned with 21 CFR Part 11 and global compliance standards.
- Secure, audit-ready database lock to finalize datasets for submission.
Data Lock & Regulatory Submission
Once all data cleaning and validation steps are completed:- Our team performs database lock, ensuring no further changes can be made to the data.
- The clean dataset is used for statistical analysis and submission to regulatory authorities (FDA, EMA, etc.).