Biostatistics & Statistical Programming
Preparation of SAP, DMC support, Data analysis and preparation of publication quality tables, listings and graphs, submission ready analysis datasets, Exploratory analysis, and data mining.
Risk Based Monitoring
Data driven Anomaly Detection and Data visualization
CDISC mapping and Define.xml
Preparation of regulatory submission data packages in SDTM, SEND and ADaM data standards along with thorough documentation via define.xml and reviewer’s guide
EDC design, setup, testing, documentation, CDISC compliant CRF design, Data cleaning and Query management
We ensure highest quality in clinical data while typical cost savings of 30-70% realized over lifetime of project when compared to other US based resourcing options. We make it possible with:
- Programming automation & process optimization using our proprietary web-based metadata driven system - Nimort. With it we:
- Create deliverables quickly and right the very first time. This avoids time wastage in iterative reviews and rework.
- Use hundreds of Internal quality checks
- Enable cross-functional sponsor teams with unparallel web-based data review tools
- Experienced US-based team:
- Team members highly experienced, efficient, and proficient in industry standards
- 100% double programming for all analysis
- We hate change orders as much as you do. To avoid these, we:
- Ensure data standards and industry conventions are used upfront
- Proactively identify & resolve gaps in data collection/analysis
Above efficiencies are dependent on use of good data management practices, close cooperation with sponsor team and minimization of changes in study design.
Introduction to Nimort
- Powerful Web-based plateform
- Uses SAS in back-end
- Compliant, audit Trailed and Validated environment
Data Integration, Coding, Cleaning and Review
- Integrated full life-cycle view of data from source to submission
- Powerful Data Review tools
- Set up data visualization in minutes
- MedDRA Coding inbuilt
- Ability to perform custom coding and Adjudication
CDISC mapping, Analysis, Reporting and submission packaging
- CDISC creation automated
- Generate & view CDISC and non-CDISC based data in browser
- Create Professional Reports in minutes without any programming background
- Supported by hundreds of internal data and metadata checks
File and Project Management tools
- Tools to Connect Deliverables, Processes and Timelines
- Organize and share files
- Take control of Access
Take a peek in Data Review features in Nimort!
To take a closer look, check our detailed demo vidios here!