Statistical Programming & Clinical Reporting
QUALITY SAS®-BASED STATISTICAL PROGRAMMING AND CLINICAL REPORTING
DataCeutics is honored to provide outstanding statistical programming and clinical reporting to all phases of clinical drug development across a wide range of therapeutic areas.
Our clients regularly recognize each member of our team of SAS® programmers and biostatisticians for producing quality work, being responsive, and for maintaining the highest level of professionalism throughout each engagement.
Our team members have an average of 15 to 20 years in the clinical data environment. >> more
Since our founding in 1995, DataCeutics continues to grow strategic relationships with clients >> more
THE VALUE WE PROVIDE TO YOU
- DataCeutics SAS® programming staff is comprised of SAS® Certified Professionals averaging 17 years of industry experience.
- DataCeutics SAS® programming staff has experience across a wide range of therapeutic areas and disease states.
- To guarantee and confirm technical skills, DataCeutics uses our own extensive SAS® statistical programming assessment.
- Strong communication skills are critical to the success as a statistical programmer. DataCeutics conducts evaluations in oral communication, writing and grammar to qualify proficiency in English and to ensure solid communication skills are in place.
- DataCeutics SAS® programmers are trained in CDISC SDTM and ADaM.
Outstanding statistical programming support for timely submissions
- Generate tables, listings and figures for regulatory submission
- Perform SAS® program verification/validation
- Generate SDTM and ADaM datasets
- Generate Annotated CRFs and define.xml
- PK/PD analysis and programming
- Perform ad-hoc analysis programming
- Generate submission-ready patient profiles
- Generate Integrated Safety and Integrated Efficacy database, analysis, tables and figures
- Generate annual safety updates
- Provide Patient Registry support
- Provide post-marketing publication support
- Perform custom SAS® development and SAS® Macro development
- Develop TLF standards, requirements and specifications
- Implement clinical report environments
- Implement DataCeutics Report Portal™ and CR Toolkit™
- Implement off-the-shelf tools to improve programming quality and efficiencies
OUR COMPREHENSIVE CAPABILITIES INCLUDE:
- 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
- Regulations/GxPs/21 CFR Part 11 Training
- Compliance Assessments
- Vendor Audits
- Business Process Consulting
- SOP Development
- Systems Selection & Implementation
- 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