Helping you Transition from Paper to Electronic Clinical Trial Management Processes
Transitioning from paper-based processes to electronic document processes offers organizations many benefits, including increased team productivity, higher quality, accelerated study timelines and risk reduction. Electronic Trial Master File, or eTMFs are an evolving area that SterlingBio has been an industry pioneer in, having over 4 years experience implementing studies with eTMF based systems and software.
SterlingBio’s eTMF consulting practice focuses on the application and design of standards-based taxonomies as a core component your eTMF management strategy. Our consultants can help you design and develop a comprehensive and personalized plan to improve your organization’s clinical trial information management through better taxonomy and metadata.
SterlingBio offers eTMF consulting services to BioPharma organizations in the following areas:
- eTMF business analysis
- eTMF taxonomy and metadata design and development
- eTMF Business Process and workflow design
- eTMF Training
What is eTMF Taxonomy & Metadata?
We define a taxonomy (sometimes referred to as an Ontology) as the classification of an organization’s data, information, content, and expertise into a hierarchical structure. When this agreed-upon classification of terms, keywords, concepts and categories is applied to your organization’s clinical trial content as metadata it becomes a powerful tool in making information work across the enterprise.
Taxonomy and metadata are the core elements of any eTMF
Where possible a taxonomy should be integrated with content management systems, document management systems, search engines, websites, portals, and any other information management tool that benefits from the functionality, consistency, and efficiency of a controlled vocabulary. A well implemented taxonomy will make information in your company more accessible, easier to locate & re-use, and ultimately, more valuable. Ideally a taxonomy is delivered in a machine-readable or computer readable format, enabling its direct use in content management or document management systems. To learn more about what an eTMF is and why you need to consider an eTMF approach for your next clinical trial, visit non-profit eTMF.org at http://www.etmf.org