The key focus for our clinical data sciences team is to deliver high-quality data, while maintaining rapid timelines.
Celerion provides full clinical data sciences services from the creation of data collection forms and standards through provision of high-quality analyzable data under expectations of the CDISC guidelines.
Celerion’s team has extensive experience and expertise in early clinical development, and has developed robust processes and SOPs to ensure we deliver high-quality data.
In addition to the extensive number of clinical pharmacology studies the team has managed, they have also focused on many special populations including but not limited to oncology, hepatic-impaired, renal-impaired and cardiac-impaired patients.
The clinical data sciences team offers the flexibility of our proprietary ClinQuick® electronic data acquisition system for studies conducted at Celerion, however, are fully capable of handling data from clinical studies conducted at third party sites.
Comprehensive services include:
- Electronic data management using ClinQuick® and commercially available EDC systems
- CRF designs in accordance with CDASH standards
- Complete data cleaning services including data reviews, logic checks and query management
- Full use of CDISC data standards including CDASH and SDTM data files
- ADaM datasets to facilitate “One PROC away” analysis programs
- Case Report Tabulation and Electronic Case Report Form deliverables for e-Submissions
- Minimum submissions standards for legacy studies