Why TFL Designer?
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Digitizes TFL analysis results
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Provides a centralized repository for TFL standards and templates
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Aligned with CDISC Analysis Results Standards and Model
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Automates TFL shell generation and provides machine-readable metadata
Revolutionizing Clinical Trial Analysis and Reporting: Faster, Smarter, and More Efficient Than Ever!
Digitizes TFL Analysis Results
TFL Designer stands as an essential solution in the modernization of clinical trial data analysis and reporting, particularly in the context of digitizing TFL analysis results. This transformation from traditional, paper-based PDFs to digital formats marks a pivotal shift in the clinical trial landscape. It equips clinical trial teams with the ability not only to delve deeper into their data but also to provide traceability and reproducibility for the results they produce. Moreover, TFL Designer goes beyond mere digitization; it establishes a singular, authoritative source of truth. This eliminates the need for repetitive result programming, thereby reducing redundancy and elevating the overall quality and reliability of the analysis and reporting process.
Provides a Centralized Repository for TFL Standards and Templates
Creating a centralized repository for TFL standards and templates marks a significant leap forward in standardizing clinical trial data analysis and reporting. This centralized hub serves as an extensive library, simplifying access and utilization for Biostatisticians and Statistical Programmers. Within this repository, Biometrics teams gain access to a wide array of disease-specific and therapeutic-specific TFL templates, encompassing both Safety and Efficacy endpoints. The library also provides TFL templates suggested by regulatory agencies (FDA, JPMA) and industry organizations (such as PHUSE and CDISC). In addition, it gives you the flexibility to develop study-specific TFL shells through template selection or by referencing existing studies.
Automate TFL Shell Generation and Provide Machine-Readable Metadata
TFL Designer simplifies the TFL shell generation process by providing machine-readable metadata, offering unmatched flexibility and efficiency. This metadata serves as a catalyst for TFL code and output production, regardless of the statistical software you prefer, fostering a realm of meta-programming possibilities. One of the standout features is its software-agnostic support, accommodating both SAS and R statistical software solutions. This adaptability empowers you to choose the tool that aligns best with your analysis needs. Furthermore, TFL Designer not only eradicates manual TFL shell generation but also dramatically reduces TFL programming hours by an impressive 50%. This efficiency ripples through the entire process, streamlining ADaM specification creation, dataset programming, reducing costs, and ultimately enhancing overall efficiency.
Aligned with CDISC ARS Model
TFL Designer is meticulously developed with the requirements of the CDISC Analysis Results Standards (ARS) Model at its core. Our platform fully supports the metadata elements outlined by the CDISC ARS model, ensuring seamless integration with industry-standard structures. This alignment enables robust and standardized clinical trial data analysis and reporting processes. Users can effortlessly extract metadata from TFL Designer in both JSON and Excel formats, perfectly aligned with CDISC ARS specifications. This metadata serves as a foundation for downstream automation processes, including the generation of Analysis Results Data and TFL codes/outputs. By embracing the CDISC ARS Model, TFL Designer empowers users with enhanced interoperability, streamlined workflows, and improved data integrity. This commitment drives efficiency and compliance throughout the clinical research landscape, fostering a seamless and effective analysis and reporting environment.
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50%
Faster TFLs
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40%
Cost savings
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200+
Safety & Efficacy Templates
Experience the Power of TFL Designer
Contact the Clymb team to schedule a demo of our TFL Designer solution and learn more about our community and enterprise-level offerings.
Community
Free
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Automated software and features update
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Develop new mock-ups shells, edit/delete items
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Support development of Tables, Figures and Listings mock-ups
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Automatically populate items based on user inputs
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Set global titles and footnotes across all TFLs
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Access to library of Safety and Efficacy TFL templates (Clymb and Community) by disease areas, TA, and indication
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Ability to create your own TFL templates by disease areas, TA, and indication
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Publish and share templates and metadata to a shared Community library
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Develop study-specific TFL shells via available templates selection or via a reference study
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Access to CDISC Standards (SDTM, ADaM, CT) via API to CDISC Library
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Input ADaM metadata as define.xml or as external metadata in Excel format
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Utilize CDISC Analysis Results Standards metadata model
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Export Table of Content and associated TFL shells in RTF & PDF formats
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Export machine-readable analysis results metadata (JSON and Excel formats)
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Create figure mockups using the integrated free and open-source Plotly graphing library for Python
Enterprise
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All the community features
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Version control and audit trail
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GxP and 21 CFR Part 11 compliant
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Central repository for your company-wide TFL templates, standards, conventions and metadata
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Collaborate and review of TFL shells and metadata in the system
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User administration and access management
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Central configuration and management
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Collaboration across multiple users
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Review, approval and governance workflows
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Metrics tracking and reporting
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Metadata management and reporting
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Custom APIs (e.g., to Sponsor MDR) and functionalities
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Business integration, implementation, training and qualification support
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Support implement downstream automation (TFL code, analysis results dataset and analysis results display generation)
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Custom Dashboard
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Service level agreement
Got Questions? We've Got Answers
What is TFL Designer and what are the benefits of using such a solution?
TFL Designer, or Tables, Figures, and Listings Designer, is a specialized tool developed by Clymb Clinical to streamline the creation of TFLs in clinical trial data analysis. It digitizes and automates the design of these essential components, offering machine-readable analysis results metadata. The benefits of using TFL Designer include improved efficiency in TFL creation, customization flexibility, alignment with CDISC Analysis Results Standards, and support for downstream automation processes including generation of Analysis Results Data and TFL codes/outputs. This robust solution streamlines data analysis workflows (keeping end in mind - going from study objectives to data collection i.e. TFL → ADaM → SDTM → CRF), leading to time savings, enhanced data quality, and more effective decision-making.
In addition to these advantages, we are actively working on a community free version. This initiative will empower the industry with broader access to TFL Designer, fostering collaboration and knowledge sharing among stakeholders. Users of the community version will benefit from a growing library of templates, use cases, and standards, accelerating TFL design and automation. Furthermore, the incorporation of FDA templates, based on recent FDA Safety Tables and Figures - Integrated Guide (STF-IG), in the community version enhances its utility and aligns it with the latest regulatory requirements. By offering a community version, we aim to contribute to a more efficient and standardized approach to clinical trial data analysis across the industry.
What technologies does Clymb utilize to develop the TFL Designer, and how do these technologies ensure regulatory compliance and industry compatibility?
Clymb employs a combination of cutting-edge technologies to create our TFL Designer. This includes React JS for front-end development, Python for various functionalities, and a back-end NoSQL database, such as MongoDB, to ensure robust data management. Git is utilized for version control.
We are also proud to be cloud agnostic, which means we can seamlessly adapt our solutions to various cloud service providers such as Microsoft Azure, Amazon Cloud, and others. This flexibility allows us to meet the unique infrastructure needs of our clients. Furthermore, our technology stack, coupled with years of experience in the field, enables us to develop solutions that seamlessly integrate into current industry processes without causing disruptions. We prioritize regulatory compliance and have incorporated essential features like audit trails and version control into our enterprise offering to meet the highest industry standards.
What statistical software does TFL Designer support?
TFL Designer is designed to provide flexibility in statistical software choices. It offers support for both SAS and R statistical software solutions. Our software-agnostic metadata ensures that you can seamlessly utilize either SAS or R for your data analysis needs, depending on your preferences and requirements.
We invite you to keep an eye out for our case studies that demonstrate the practical application of TFL Designer. Additionally, watch for our presentations and demonstrations at upcoming conferences, where we showcase the power and versatility of this tool. If you're interested in leveraging TFL Designer without disrupting your current data flow and statistical tools, please feel free to reach out to our team. We'd be delighted to discuss how we can tailor our solution to align seamlessly with your unique requirements.
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