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
Our Services
- Nimble Workspace Support. Facilitating:
- Setup, managing and Training
- DMC reporting
- Safety data reviews
- Adjudication
- Dashboards, Reports, TLFs
- Statistical Programming
- CDISC, SDTM, Define.xml
- Biostatistics: SAP, shells, DMC support
- Data Management
Statistical Programming
We ensure highest quality in programming deliverables while typical cost savings of 30% or more over other options.
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
Biostatistics Consulting
- SAP & Shells
- Sample size calculation
- Randomization
- DMC statistician support
- TLF review
- Statistical input into study design and protocol development
Data Management
- CRF development
- Database build & design
- Edit check development & UAT
- DMP development
- Programmed listings for data review
- Programmed Patient Profiles
- Data reconciliation & cleaning support
Democratizing Clinical Data
In Nimble Workspace
An accessible way to see visualize & analyze clinical data.
Tables, Listings, Graphs
In Nimble Workspace
- Effortlessly create sophisticated TFL in minutes
- Create TFL via text search
- Ability to create most TFLs including statistical Reports via graphical interface.
- CSR/publishing quality reports without the help of traditional statistical programmers
Patient Profiles
Via Nimble Workspace
Quickly Design graphical profiles from scratch without programming
Automatic
Our AI system will automatically create profiles
Fine-Tune
Drag-n-drop functionality to customize without need of programming
Graphical
Create sophisticated graphical profiles, with minimal effort
Collaborate
Review, Share, enter notes, work together
DMC Services
- Charter Development
- Independent Unblinded Statistician
- Traditional TFLs: Supported by Statistical Programmers
- TFL Via Nimort Workspace: Accelerated, Collaborative & Economical
Safety Data Review
Via Nimble Workspace
- Reconciliation, Adjudication, Tracking
- Data visualization on fingertips
- Dig into outliers, issues instantly
- All the data, reports, profiles at one place
- Achieve single source of truth in clinical data
Resources
Risk based monitoring, a key component of centralized monitoring, is gaining popularity
While working with define.xml, usually we are focused on its creation for
CDASH is positioned as a standard to collect data to provide traceability from
FDA submission requirements to use CDISC's SEND data standard is going to
In 2013 CDISC came out with define XML specification version 2.0. Unlike
Define.pdf can be a great supplement to define.xml for multiple reasons. Apache