Data
Management

• EDC and Database Setup
• IWRS and CTMS Setup
• Query Management
• Edit Check
• CRF Design and Annotation
• Database Lock

Biostatistics and Programming

• Study Design
• SAP Development
• Sample Size Calculation
• Interim Analysis, DMC
• Company Standards Development (e.g., CDISC)
• SDTM, ADaM, Define.xml, TFL
• Regulatory Submission - ISS/ISE, SDTM/ADaM Submission Package

AI / Machine Learning

• Machine Learning model development
• MLOPs
• Generative AI and Large Language Model Implementation
• Patient Recruitment
• Medical Coding
• Data Anomaly Detection
• Safety Signal Detection ( PV)
• Predictive Modeling

Data
Science

1. Open-source Programming - R, Python
2. Data Visualization - R Shiny, Tableau, Power BI, Spotfire
3. Predictive Analytics
4. Cloud Computing - AWS
5. Data Warehouse - CDR for Clinical Data
6. Big Data Analytics
7. RWE
8. Training and Consulting