Statistical Analysis
& SAS Programming
CDISC
Clinical Data Management
Biostatistics
Project Management
Medical Writing
Regulatory Affairs & E-Submission
- Design Data Specification
- Develop Analysis Datasets (ADaM/non-ADaM)
- Develop TFL
- Integrated Studies: Pooling, ISS, ISE
- Support NDA, BLA, Exploratory Analysis, Interim
Analysis, Publications, FDA request, Ad-Hoc Analysis
- Quality Control (QC)
- Quality Assurance (QA)
CDISC
- SDTM Training
- ADaM Training
- Design Mapping Specifications/SDTM
- Annotate SDTM CRF
- Design define.pdf/define.xml for SDTM
- SDTM Data Standardization/Conversion
- SDTM Compliance Check
- ADaM Compliance Check
- CDISC Submission
Clinical Data Management
- Design and Annotate CRF
- Design Data Management Plan (DMP)
- Data Entry, Data Cleaning and Data Validation
- Database ETL (Extract/Transform/Load)
- Lab Standardization
- Medical Coding
- EDC Training
- EDC Data Management
Biostatistics
- Design Statistical Analysis Plan (SAP)
- Design Protocol
- ISS/ISE Analysis Plan
- Develop Clinical Study Report (CSR), ISS/ISE
Report
- Interim Analysis Report, Exploratory Analysis
Report
- Statistical Modeling
- Calculate Sample Size and Power
- Clinical Trial Design
- Randomization
- Blinding/Unblinding
- Database Close/Lock
Project Management
- Budget Control
- Delivery
Medical Writing
- Support Protocol/CSR
- Support ISS/ISE
- Support Publication/Manuscript/Presentation
- Support IND/BLA/NDA
Regulatory Affairs & E-Submission
- US Electronic Submission
- European Electronic Submission
- Japan Electronic Submission
- Regulatory Compliance