Database Design and Development
We specialise in designing and building secure, scalable, and user-friendly databases tailored to the unique requirements of each clinical trial.
Data Cleaning and Quality Assurance
We employ robust data cleaning and quality assurance processes to identify and resolve discrepancies, inconsistencies, and errors in clinical trial data, including building custom reports.
Data Standards Implementation
We adhere to industry standards (CDISC compliant) and regulatory requirements for data collection, formatting, and reporting, ensuring compliance with FDA, EMA, TGA, and other regulatory agencies.
Safety and Adverse Event Reporting
Our experts handle the timely and accurate reporting of safety data and adverse events, prioritizing patient safety and regulatory compliance.
Metadata Management
We manage metadata effectively, ensuring that data elements are well-defined, standardised, and traceable throughout the data lifecycle.
Clinical Database Lock and Freeze
Our team coordinates the database lock and freeze process, ensuring data integrity and readiness for statistical analysis and regulatory submission.
