Experience includes working with internal and external teams to install and manage Pinnacle21 Enterprise including setting up various dictionaries (MedDRA, WHODrug, SDTM CT, ADaM CT, UNII, SNOMED). Creating and providing training to internal and external programming staff. Registering Compound/Studies from study start up and maintaining ongoing studies. Additionally, manage study validations, issues management and escalation. During study close out ensure all validation Errors, Warnings, and Notes are addressed or unresolved findings are documented and added to Reviewers' Guides (SDTM and ADaM) for FDA and PMDA (PMDA issues are discussed with agency and approved prior to submission). Additional tasks include creating a master Validation issues file that explains common approaches to resolve or address validation findings. Validation includes SDTM, ADaM, and associated Define.xml.
Use Pinnacle21 Community version to validate CDISC SDTM and ADaM Piolet Data
Pinnacle21 Community version used to create SDTM and ADaM specification. Pinnacle21 can be used to create empty define.xml specification file which can used to create actual SDTM or ADaM specifications. Since the foundation is already build for SDTM and ADaM specification and associated define.xml generation. The files can be leveraged as a tool to create data standards. Additionally, similar template can be used to create Master Data Standards file for SDTM and ADaM at Global/Compound/Study/Therapeutic Area levels.