Manage core clinical trial information as metadata.
StrucTrial structures core clinical trial information so that SAP, TLF, and broader clinical documents can be created and updated within a consistent framework.
Designed from hands-on experience across CO, DM, and STAT workflows.
Product
StrucTrial manages core clinical trial information as structured metadata and provides a foundation for CO, DM, and STAT documents to be drafted, reviewed, and updated under a single consistent standard.
Demo Version
The current demo version focuses on statistical and analysis-related documents such as SAP and TLF shells. It shows how inputs including study design, visit structure, analysis populations, endpoints, and output scope can be organized as metadata and connected to the foundational structure of clinical documents.
StrucTrial is not simply a document auto-generation tool. It is a solution for structuring and managing key information repeatedly used across clinical trials as metadata.
By providing a foundation for updated information to be reflected consistently across related documents, StrucTrial aims to reduce document inconsistencies, repetitive revisions, and the risk of missing updates.
StrucTrial is designed to evolve into a metadata-driven foundation for clinical trial documentation, supporting consistency, traceability, and controlled updates across CO, DM, STAT, and reporting workflows.
- Metadata-based structuring of core clinical trial information
- Document framework generation for SAP and TLF shells
- Structural consistency across CO, DM, and STAT documents
- Foundation for automatic updates across related documents when information changes
- Document quality maintenance and traceability from a QM perspective
- Scalable structure for broader clinical document coverage
Clinical Trial Metadata
Manage protocol design, visits, endpoints, analysis populations, and output scope as structured data that can serve as the basis for document preparation.
Document Update Foundation
Help core information be reflected consistently in related document frameworks, reducing repetitive revisions and inconsistencies across documents.
Clinical-Wide Scalability
Go beyond document generation toward change tracking, document consistency, and output quality maintenance from a clinical trial QM perspective.
About
StrucTrial was developed from hands-on experience in clinical data management, statistical programming, and clinical operations.
I earned an M.S. in Biostatistics from the University of California, Davis in 2018 and have gained practical experience across clinical operations (CO), data management (DM), and statistical programming within the pharmaceutical industry.
Through clinical trial work, I experienced the inefficiency of repeatedly preparing foundational document structures for CO, DM, and STAT workflows, even when the core study information had already been defined.
Maintaining consistency across documents and quality across outputs often required significant manual effort.
StrucTrial aims to reduce these inefficiencies by managing clinical trial information in a structured form and supporting practical documents so that they can be created, reviewed, and updated within a consistent structure.
Ultimately, StrucTrial supports a metadata-driven documentation framework designed to improve consistency, traceability, and quality across clinical trial outputs.
Background
- Biostatistics M.S., University of California, Davis, 2018
- Clinical Operations Hands-on experience in clinical trial operations and document management
- Data Management Experience in clinical data structure, review, and quality management
- Statistical Programming Experience in TLFs, analysis outputs, and clinical statistical documentation
Contact
For product inquiries, demo requests, or collaboration discussions, please leave your message below.
Or contact directly: structrial.support@gmail.com