Clinical Data Management (CDM) covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. Once data is stored, implementing data validation steps is crucial to ensure accurate data is collected and complies with ICH-GCP and all applicable global and local regulatory requirements. Once the data collected is fit for analysis, the database is locked to avoid any modification and datasets are delivered to statistics and programming teams for analysis.
By choosing Citrine Healthcare to manage your Clinical Data Management, you can be confident your clinical trial will be delivered on time with the highest quality data collected. We use multiple industry-leading electronic data capture (EDC) technologies suited to your requirements and adapted to a decentralized/virtual trial approach.
We offer an end-to-end Clinical Data Management solution including, rapid database launch; integrated clinical data sources; expert medical coding, query management and resolution, effective external vendor data management, database lock; and clean, quality clinical trial data.
We provide bespoke solutions and provide real time, quicker access to data, meaning faster decisions can be made and patients are safe at all times.
We have selected a range of EDC partners, offering you flexibility and a range of features to keep up with the latest technological advances and your varying data requirements. These EDC systems offer integrated solutions beyond traditional EDC which allow real-time access to data from different sources.
Our data management experts review the clinical trial protocols to identify the best suiting data collection framework for your study and portfolio.