Clinical Data Management

Capturing high-quality clinical trial data is crucial to ensuring patient safety and confirming efficacy in clinical development. At PharBioMed, 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
Integrating electronic data from various sources
Designing, developing, and validating eCOA and ePRO instruments
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