Data science + exceptional CDISC expertise = METRONOMIA
At METRONOMIA, our CDISC experts are your CDISC experts if:
- You require CDISC expertise, but do not have the resources in-house
- Repetitive discussion about data-driven activities project after project is an issue
- You would benefit from having one point of contact to one integrated team of CDISC experts
- Constant access to CDISC compliant clinical data, integrated across all studies, for the purpose of submission, due diligence, safety reporting and/or interactions with regulators is required.
Why METRONOMIA? We are a registered CDISC Gold member with in-depth knowledge in SDTM and ADaM data structures, reviewers' guides, CDISC terminologies and associated deliverables, advising on and adhering to CDISC standards (e.g., CDASH, SDTM, ADaM, and define.xml). We have provided CDISC deliverables for over 210 studies often as part of NDA or BLA submissions. The conversion of legacy studies as a part of the process is a complex and challenging activity, in which METRONOMIA excels. Furthermore, we have developed and maintained integrated CDISC compliant data repositories for entire development programs with large numbers of studies.
Allow our experts, who are actively involved in CDISC user groups and in the development of CDISC processes and tools, to convince you that we are the right partners for your CDISC needs!
- Consultion on appropriate data structures and conversion strategies
- Development of company standards for data consistency across studies and products, enabling data integration, pooled reporting and submission-ready data
- eCRF development according to CDISC CDASH standards
- Creation of study databases in line with CDISC SDTM and programming of compliant datasets
- Conversion of current and legacy data to CDISC standards
- Development of CDISC ADaM datasets for statistical programming of TFLs
- Adherence to Full Pinnacle 21 validation of all datasets
- Generation of submission-ready packages, including define.xml, CDISC reviewer’s guides, SDTM annotated CRFs
Recent CDISC achievements @ METRONOMIA
- Time-critical mapping of >15 legacy studies to SDTM and ADaM for FDA submission
- Update of a large, integrated CDISC SDTM compliant database with >40 studies to a new version of the CDISC Implementation Guide
- Consultancy to a multinational pharmaceutical company on CDISC SDTM and ADaM strategy, including conversion of legacy and ongoing studies
- Support of >45 studies with CDISC SDTM and ADaM deliverables in the past 12 months
"A prerequisite for METRONOMIA is fluency in CDISC, CDASH, SDTM, ADaM, and define.xml standards. You can count on us to be knowledgeable on the current and upcoming developments, and to translate these to serve your company and projects. We would be happy to share our expertise, just contact us!”