Xbiom - Version REGULATORY - Workbench for Clinical Metadata Governance and Trial Management
From Xbiom Clinical
Digital Metadata Governance & Clinical Regulatory Compliance: Management and governance of CDISC and corporate standards driven metadata, data models and study level models from protocol to submission with workflows and controls. Solution for clinical trial data submissions in CDISC SDTM to comply with FDA and PMDA mandates. Accept and validate data from CROs with centralized data management and provisioning to biostatisticians and programmers for data analysis. Plan interim and final submissions, package M5 folders with ISS, ISE and TFLs for submitted studies.
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Submission Package Lifecycle Management:
Submission Package Lifecycle Management:
- Prepare studies and pool datasets (ISS, ISE) for a submission, assign users, import data, perform validation checks, approve and export the submission package.
Study Lifecycle Management:
- Create studies, assign users, import data and statistical analysis deliveries, perform validation checks, acknowledge and reject data through study workflow.
Terminology:
- Manage terminologies by creating and linking code lists that enable data transformation and search, standard and sponsor defined terminologies.
Standard Model Management and Metadata Governance:
- Manage standard and sponsor-defined data definition and model and all metadata and data models.
User Administration:
- Manage user groups and roles. Configure access rights per role.
Folder Templates:
- Manage folder templates for submission and study data package.
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