Functional Services
DataCeutics premier collection of specialty services
DataCeutics has been supporting the life science industry since 1993 and is a leading authority in delivering outstanding services to pharmaceutical, biotech, and medical device companies.
Using the most current technology and industry standards, we provide outsourcing support, consulting support, validation support, exceptional software and innovative solutions to clinical data management and biostatistics groups throughout the world.
As a Functional Service Provider, DataCeutics becomes an extension of your in-house resources, providing an intimate level of service. Specializing in Waban SCE, EDC Systems, SAS® Drug Development and SAS®-based tools, we provide a full range of support including:
- Consulting
- Application Support
- Outsourcing
- Compliance and 21 CRF Part 11
- Validation Services
- Software Tools
Tell a Colleague
Learn about the history and milestones
Since our founding in 1995, DataCeutics continues to grow strategic relationships with clients >> more
Since our founding in 1995, DataCeutics continues to grow strategic relationships with clients >> more
Outstanding statistical analyses for clinical drug development
DataCeutics programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays across therapeutic areas and in any phase of drug development. >> more
DataCeutics programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays across therapeutic areas and in any phase of drug development. >> more
Process Development & Documentation
- SOP & Guideline Development
- System Validation
- Compliance and 21 CFR Part 11 Support
- Strategic Process Design
Data Management Programming
- Installation and Validation
- Data Migration
- Database Design & Standards Development
- Edit Check Design and Programming
- Add-On Products
- User Training
- Long-Term Support
- Compliance and 21 CFR Part 11 Support
OUR COMPREHENSIVE CAPABILITIES INCLUDE:
- Biostatistics
- SAS® Statistical Programming
- SAS® QC/Verification/Validation
- Protocol Deviation Programming
- SAS® Verification Programming
- Clinical Reporting Tools
- SAS® Systems Development
- Systems Development Life Cycle Methodology
- IEEE Development Methodology
- Standards Implementation
- CDISC CDASH/STDM and ADaM Services
- Electronic Submissions
- Statistical Computing Environment Support
- IT Environment Support
- Clinical Study Report Auditing
- QA
- Regulations/GxPs/21 CFR Part 11 Training
- Compliance Assessments
- Vendor Audits
- Business Process Consulting
- SOP Development
- Systems Selection & Implementation
- Validation
- Test Scripts
- User Acceptance Testing
- Electronic Data Capture (EDC) System Support
- Clinical Programming
- Edit Check Programming
- Data Entry Support
- Clinical Data Management Support
- Medical Writing
