Bringing new drugs, diagnostics, and vaccines to market for diseases afflicting under-served populations outside the U.S. is a challenge normally left to Government and charitable non-profits. Diseases without a market of paying customers are often neglected, and new treatments for them are rare.
Data standards offer hope for cutting the cost and raising the efficiency of clinical research. Nowhere is this more important than in the field of neglected diseases. The CDISC data standards are free, global, and platform-independent. Used correctly, the CDISC models promote cost savings from data collection through reporting. With standardization, pooling is possible, and large pooled datasets can substitute for new studies to shed light on disease progression and drug safety. Services for these projects may include:
- SDTM Data Modeling and Review
- CDASH Implementation
- SDTM, ADaM, and Define.xml Workshops
- Evaluation of SDTM Data and Documentation
- Vendor Support