The upfront implementation of the data standards in a sponsor’s data management and statistical environment enables sponsors to automate the exchange of specifications and instructions to their internal and external partners.
A central data standards library and a metadata repository cannot only be used to generate study specifications, but will also enable the verification of the study data and metadata against the specifications.
Business & Decision Life Sciences supports its clients in the development and maintenance of such a Clinical Data Standards Platform.
Support can be provided for one or more of the platform elements below:
- Creation of a Data Standards Library including an (e)CRF Library, CDASH/SDTM/ADaM Library and Therapeutic Area Library
- Set-up of a Study Specification process by specifying the specifies the visit schedule and the needed (e)CRF templates and auto-populating a Study Metadata Repository
- Development of a metadata repository to enable:
- Study build
- Data model compliance checking
- Define.xml generation
- Conversion automation
- Implementation of a metadata extraction program to provide Study Metadata Specifications (e.g. define.xml CRT-DDS format) to partners
- Solution to manage and measure conformance to your standards across partners and projects
- Comparison against Study Specifications
- Validation against the Data Standards Library
- Generation of pooled analysis based on CDISC data (ISS and ISE)
- Creation of macros for ADaM dataset creation