Under the leadership of Susan Mutter, who has over 25 years of diverse experience in clinical database design and management, and statistical programming, PROMETRIKA has assembled a team of highly experienced CDISC SDTM mapping experts. For more than 12 years, Ms. Mutter, who is a member of the CDISC Advisory Council, has helped sponsors implement CDISC standards and meet regulatory requirements for clinical trial data submission.
PROMETRIKA’s team of experts, with experience across a multitude of indications, have complementary specialties and work together as a cohesive team. This core group works within the greater PROMETRIKA Biostatistics and Statistical Programming team, and processes data from EDC extraction, through SDTM and ADaM mapping, culminating in the Tables, Listings, and Figures for the Clinical Study Report. The team’s mission is to produce high quality, submission-ready CDISC datasets, and the associated documentation, for the US FDA and regulatory bodies worldwide.
With our smaller, highly experienced, completely North American-based team, PROMETRIKA can provide exceptional clinical trial data submission support and expert guidance, from inception and execution to submission and support of regulators’ requests during their final audit, with a personal touch. Whatever your particular clinical trial needs, we can make it happen, and set you on the path towards a successful submission.
PROMETRIKA, a Platinum CDISC member, provides CDISC training to all of its employees. PROMETRIKA has team members on the ADaM SDS team and actively presents at industry conferences such as MassBio, PharmaSUG and CDISC International Interchange. PROMETRIKA’s combined experience spans several decades, with hundreds of mapped studies and many successful US FDA and rest-of-world regulatory authority submissions.
PROMETRIKA provides the following CDISC services:
- Consulting on CDISC implementation
- CDASH compliant EDC builds in Medidata RAVE
- Standard forms library
- Data visualization support
- Mapping current and legacy data into CDISC SDTM standards
- Mimic existing studies/client standards implementation
- Single and multiple studies
- Controlled terminology updates
- Dictionary coding updates
- Preparation of eSubmission-compliant legacy datasets
- Preparation for ISS/ISE at SDTM and/or ADaM level
- Submission-compliant CRF annotation
- Define.xml preparation
- SDTM and ADaM data reviewer’s guides
- Documentation and support for regulatory agency audits