Nimble Workspace
A Data Visualization & Reporting Platform for
DMCs, Safety Data Reviews, Adjudication, Visualization, and creating TLFs
Web-based, Comprehensive, Automated, AI Based and Collaborative
Import
Automatic AI based mapping of EDC data to Clinical Ontology during import
Prepare
Derive data, Auto Define populations, filters, formats
Create
AI based creation of TFLs & profiles
Collaborate
Dashboards, Share, Review
SDTM Automation
- Automated SDTM, SEND, and ADaM creation for submission-ready regulatory formats.
- Graphical data flow and Excel-like browser interface for easy specification creation.
- Low-code R based platform, where R programs can be exported to reproduce data offline
- AI-powered machine-readable specification generation minimizes manual effort and mistakes.
- Automated Define.xml generation in minutes from the same specs used for dataset creation
Dashboards & Insights
- Comprehensive dashboards for safety, operational insights, data quality, and patient experiences.
- Accelerate insights by 5-20x through intuitive & fully customizable dashboards and DIY visualizations with advanced filtering options, enhancing productivity in clinical trials.
- Template-based visualization for quick generation of reports and dynamic trend analysis.
- Seamless integration of AI for on-demand queries and interactive data exploration.
Patient Profiles
- Speed up data review with data changes highlighted since the last assessment with delta review.
- Visualize full patient data journey via highly interactive-graphical profiles along with listing-based profiles.
- Display a wide range of data, including safety, efficiency, and oncology in comprehensive profiles.
- Compare profiles side-by-side within a subject (graphical vs. listing) and across different subjects for detailed insights.
- Accelerate patient narrative documentation with functionality for AI based summarization.
Enhanced Data Quality
- Enhanced data quality via comprehensive data quality checks, from basic validations to complex AI based checks.
- Ready-to-use dashboards provide visualization and metrics for data integrity and consistency.
- Offers data reconciliation checks to maintain accuracy across various data sources.
- Collaborative Data Review: Replacement of traditional excel files with an in-built system for collaborative data review and tracking across users, promoting teamwork and accuracy
Risk Based Quality Management (RBQM)
- Risk Identification: Proactively identify potential risks using advanced algorithms.
- AI–powered Analysis:
- Assessment: Evaluate the impact and likelihood of identified risks.
- Centralized Monitoring: Monitor data and operations from a central platform for a holistic view.
- KRI Tracking: Track Key Risk Indicators in real-time to ensure timely interventions.
- QTLs: Monitor Quality Tolerance Limits to maintain the highest data standards.
- Adaptive Actions: Implement corrective and preventive actions based on insights.
AI-powered Workflows
- Generate immediate insights and narratives with on-demand AI analysis by interacting with data.
- Design AI-driven narratives and summaries quickly with an intuitive interface.
- Accelerate RBQM with AI for automatic signal analysis and data summaries.
- Produce automatic query texts for data quality checks seamlessly.
- Enhance data visualizations with rich, point-and-click AI interactions.
- Streamline data standardization with rapid AI-driven SDTM mapping.
CSR, DSUR & PSUR
- Create any statistical table, listing, or figure for regulatory submission ready format.
- Quickly generate tables and figures with efficient point-and-click templates.
- Specialized templates can be created rapidly to meet specific client needs.
- Export TFLs in RTF and other formats; export R programs for submissions.
- Reuse reports across projects with powerful search and linked report capabilities.
Interactive DMC
- Web-based access enhances stakeholder collaboration, including DMC members.
- Unified data preparation and reporting streamline all aspects crucial for DMC tasks.
- Flexible blinded/unblinded data management and team isolation for tailored project offshoots and updates.
- TFL creation efficiency and exportability
- Sophisticated mobile friendly Interface with intuitive navigation and simple data filtering improves DMC analysis effectiveness.
Signal/Issue Management
- Centralized tracking of signals/issues and resolutions, streamlining management and oversight.
- Click to create signals directly within data visualizations for instant issue identification.
- Customizable features align with project and organizational needs, enhancing adaptability.
- Instant or digest email notifications available, boosting communication efficiency.
- Workflow-integrated commenting enhances documentation clarity and project communication.
- Systematic, cross-functional collaboration and detailed audit trails promote transparency and accountability.
Biostatistics & Programming
ADaM/TFLs
Preparation of analysis datasets, CSR report package, ISS/ISE
SEND/SDTMs/define
Regulatory compliant data creation and packaging including SDTM datasets, SEND datasets, annotated CRF, define.xml/pdf.
Other Analysis
DMCs, annual report, interim analysis, safety monitoring, exploratory analysis, clinical listings
Programming Automation
Use our proprietary metadata driven system for all programming, achieving great efficiency
Process Optimization
Run hundreds of internal quality checks, and use integrated project management tools to ensure smooth flow of deliverables.
Expert Team
Experienced in major therapeutic areas, efficient and proficient in industry standards. 100% double programming
SAP Preparation
Expertise in preparing detailed Statistical Analysis Plans.
Shell Creation
Design data shells for efficient data representation.
DMC Support
Experienced in major therapeutic areas, efficient and proficient in industry standards. 100% double programming
