Celerion offers a fully integrated SAS® Drug Development platform that provides a centralized system for managing, analyzing, reporting and reviewing clinical research information.
SAS Drug Development enables Celerion to offer a seamlessly integrated and traceable process to support data from acquisition through data submission to regulatory agencies.
Benefits include:
- Reliability: Improved data integrity through seamless integration with complete traceability
- Consistency: A standardized approach to data collection from multiple sources, uploaded and integrated into a centralized repository to provide a secure and consistent data structure
- Speed: Faster access to data for all clients and immediate access for those with in-house SAS Drug Development enabling faster go/no-go decisions by up to four to six weeks of the drug’s overall development timeline
- Submission-ready Data: Full compliance with regulatory requirements including 21 CFR Part 11, good industry practice, CDISC and CDASH standards enables submission-ready data and potentially faster review by FDA and other regulatory agencies
For details on how a top 20 Pharma client was able to expedite its drug-development time by four to six weeks leveraging SAS Drug Development, please click here.
For sponsors with in-house SAS Drug Development platforms, data can be immediately transferred throughout the study from ClinQuick® (Celerion’s proprietary electronic data-acquisition system). The transparency and traceability of data analysis across the data life cycle ensures seamless integration and enables sponsors to easily and confidently address inquiries from regulatory agencies.
Data from multiple sources such as ClinQuick and bioanalytical data from systems such as Watson LIMS can be uploaded easily and reviewed across the study or multiple studies using SAS Drug Development.
For more information on our how our SAS Drug Development services can support specific study needs and expedite drug development, please click here.