Data Management

Our team of industry experts have extensive experience developing and delivering quality services for data management departments across all major therapeutic areas and phases for pharma/biotech companies. Dedicated in our belief that each client should have their own unique tailored experience, quality is the center of all activities. Each team member is hand selected for each study with an expertise and passion to get effective treatments into patients more efficiently. We will create an implementation “blueprint” that will serve as our path forward together, supporting your functional, operational and relationship requirements while fostering a mutually beneficial partnership. Establishing a solid foundation of support from the beginning is key to the success of any study.

Clinical Data Operations

Staff Augmentation
- CDM Management (Manager and Director levels)
- Lead Clinical Data Manager
- Project Manager
- Clinical Data Management Reviewer
- Biostatisticians
- Statistical Programmers
- Data Scientist
- Python Developers
- R Developers
Infrastructure Support
- Global resourcing oversight
- Creation, modification, or review of standard operating procedures (SOPs)
Operational Support
- Operational delivery oversight
- Project/timeline management
- Perform vendor oversight of CROs and/or external data vendors
eCRF design
SAP Development
Statistical Analysis
TLFs
ADaM / SDTM
Standards Consulting
Database development and testing
Data entry and tracking
Database closeout and archiving activities
Discrepancy management
External data reconciliation
Medical coding
Laboratory data management:
- Safety
- Local
- Biomarker

Technology

Staff Augmentation
- Data Scientist
- Python Developers
- R Developers
Education
- SAS to R Training
Services
- Use Assessment
- R Package Development / Validation
- R Studio Installation
  - R Studio IDE
  - R Studio Connect
  - R Studio Package Manager
  - Additional Clinical Add-Ins
- R Programming Services
- Python Programming Services
- Dashboard Development
- Shiny App Development
- Package Management