Notes from the 23rd DIA CDM Conference
Susan Duke of GSK chaired a session on Tuesday, March 18th, called "Statistical Computing Environments: Collaboration through Metadata, People, Process and Software." During this session, Christopher Colangelo, Associate Senior Statistician, presented Eli Lilly's effort to implement SAS Drug Development (SDD) as a centralized but globally available repository for clinical data.
But first, and for those unfamiliar with this relatively new concept, a Statistical Computing Environment (SCE) is a combination of hardware, software and processes, that enable the collection, management, analysis, and transparency of operational data within a life sciences environment performed in compliance with government regulations and operating best practices. From a technical perspective, it is also an extension of a relatively new software category called "Clinical Data Repository" or CDR.
You can learn more about both SCE and CDR via the following posts on this web site:
- Clinical Data Repository (CDR) 101
- Clinical Data Repository (CDR) Vendors
- Of CDR, CDMS and EDC
- The EDC, CTMS, CDM Confusion
- DIA Reflections: The Importance of Semantics
- Genzyme: Biostatistics with Waban SCE
At Lilly, the selection of SDD arose from the recognition that internal staff in Data Management, Data Delivery, Statistics, Medical Communications and external partners such as CROs needed an environment that would allow for greater collaboration within a secure environment.