In answer to the FDA ‘specific requirement for all clinical firms to provide study data standards, BioPharm Systems offers a product that loads the domains modeled from the CDISC’s Study Data Tabulation Model (SDTM) Implementation Guide (SDTMIG) into the Global Library. Loading a pre-defined library also saves on costs as well as project time during first pilot and all future studies
Our Product includes:
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SDTM-compliant domains modeled in SDTMIG v3.1.2 with questions and question groups.
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DVGs for CDISC Controlled Terminology for existing SDTMIG variables.
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DCMs for each SDTMIG Domain.
Additional Consulting
Although pre-defined libraries save on resources, often times further customization is required. BioPharm associates will migrate legacy data into standards as well as adjust DCIs and DCMs to client-specific requirements.
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Creation of DCM character and graphic layouts.
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Creation of domain-specific DCIs.
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Customization of key templates and extract views.
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Creation of Derivation Procedures for ISO 8601 dates and conversion of data collected in a horizontal format to the SDTM vertical form.
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Question sets for Adverse Events and Concomitant Medication Coding.
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Validation documentation for loading programs.
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Validation documentation for loading programs.
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Addition of variables from the General Observation Class tables.
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Creation of custom (non-modeled) domains.
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Creation of DVGs for variables with no CDISC controlled terminology.
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Creation of DVG subsets.
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Development of processes for creating Trial Design datasets.
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Development of additional derivation and validation procedures.
