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.
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.
- 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.
- Manage user groups and roles. Configure access rights per role.
- Manage folder templates for submission and study data package.