CIMS can help you with all the challenges of information model management in CDISC
CDISC is not just about having the right model is also about:
Governances of data standards
CRO data exchanges
Map against your CROs data models
Maintain exibility within the borders and rules of governances
Agility of data model upstream in CRFs
Why is it complicated?
It’s complicated because SEND must balance and integrate requirements and constraints coming from Existing data models, Vendor integration, Health authorities, statistical functions, IT systems, Pre-clinical and Clinical functions, external LABs, Governances, CDISC standards, GXP, Regulatory, etc.
Integration is key:
- Quality Assurances is based upon a consistent model
- Quality control is a must
- Don’t act as experts, nobody is, even if they say they are
- SEND requires a lot of common senses
- Team work is a pre-requisite
- Representatives from Toxicology, Pathology, Bioanalytical, PK, Regulatory Affairs, Quality Assurance, Information Technology, DM, CROs, LABs
What have worked for others!
SEND is on everybody’s lips!
It’s not due to the complexity, or implementation challenges. It takes time in calendar time. And must be done in the right sequences:
- Data source identification
- SEND model build
- FSP integration
- Data exchanges specication
Then it’s the governances and Quality control after gone live that most people
find difficult to implement.
It’s the cross functional parts and the organizational psychology of change.
Solution that CIMS have seen works is:
Let DM handle SEND via a new Governances structure implementation which has its foundation on SDTM
- Write specic SEND SOPs underneath the SDTM SOP
- And implements a QA & QC function or hire somebody to do it for you