Clinical Data Management
Capturing high-quality clinical trial data is crucial to ensuring patient safety and confirming efficacy in clinical development. At our organization, we specialize in facilitating efficient data collection, cleaning, validation, and management processes. Our comprehensive Clinical Data Management services are designed to improve overall efficiency, enable informed decision-making, reduce development costs, and mitigate risks.
Our end-to-end Clinical Data Management services include:
- Protocol review
- Designing, validating, and maintaining CDISC/CDASH compliant CRF/eCRF
- Selecting, launching, and configuring the most suitable Electronic Data Capture (EDC) system for your study
- Integrating electronic data from various sources
- Designing, developing, and validating Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient Reported Outcome (ePRO)
- Database design, development, and maintenance
- Data validation and entry
- Data cleaning and query management
- Medical coding utilizing WHO Drug and MedDRA dictionaries
- Reconciling Serious Adverse Events (SAE)
- Database locking and post-lock archival
- Reconciling external vendor data using SAS listings
- Integrating Randomization and Trial Supply Management (RTSM)
- Developing custom listings in SAS
- Generating Patient Profiles
- Facilitating database transfers
