DATA MANAGEMENT
& BIOSTATISTICS
Measurable efficiency. We take full ownership of the data lifecycle — from EDC/IWRS design to final statistical reporting.
WE ADDRESS YOUR KEY CHALLENGES
Manage critical risks and delays at key trial stages
SLOW ECRF SETUP AND UNCLEAR TIMELINES
EDC for review
data collection
Our solution
EDC ready for review within 5–7 days.
Full data collection launch in up to 3 weeks.
FRAGMENTED DATA, NO SINGLE SOURCE OF TRUTH
Our solution
integrated EDC/IWRS and analytics in a single secure environment with 24/7 access
REACTIVE INSTEAD OF PROACTIVE QUALITY CONTROL
Our solution
Real-time risk monitoring and early detection of deviations before timelines are impacted.
NON-TRANSPARENT STATISTICS AND COMPLEX REGULATORY REPORTING
Our solution
End-to-end biostatistical support and preparation of regulatory-ready outputs in CDISC (SDTM, ADaM) formats.
FULL SCOPE OF SERVICES:
FROM CRF DESIGN TO REGULATORY SUBMISSION
DATA MANAGEMENT
BIOSTATISTICS
DESIGN & SETUP
- End-to-end EDC/IWRS development and validation
- CRF Design and Data Management Plan (DMP) Development
Planning
- Statistical sections of the study protocol
- Statistical analysis strategy development
- SAP development and TLF mock-ups
MONITORING & QUALITY CONTROL
- Continuous data monitoring and quality oversight
- Medical data review
Statistical Analysis
- Tables, listings, and figures (TLFs)
- Interim and final statistical analyses
Database Lock
Preparation
- Data validation and transformation to CDISC (SDTM)
- Database lock preparation and clean data delivery
Reporting
& Submissions
- Clinical Study Report (CSR) preparation
- Regulatory submission support
WE OFFER A COMPLIMENTARY AUDIT OF YOUR PROJECT STATUS
From a data management and biostatistics perspective
INTERACTIVE DASHBOARD & REPORTS
See how your data will look in real time
CUSTOM LAUNCH
PLAN
Clear timelines and milestones for your project
STREAMLINING GUIDELINES
Accelerate processes and reduce costs without compromising quality
WHAT YOU GET WITH K-RESEARCH
Speed
& Predictability
Data collection begins just 3
weeks from project start
Full Transparency
All data and key metrics (enrollment rate, data quality, safety) available via secure interactive dashboards — anytime
Quality-First Approach
Proactive risk monitoring instead of post-hoc corrections. Full compliance with ICH GCP and CDISC standards
Dedicated Accountability
An experienced project manager as a single point of contact
Scalability
Flexible team and services tailored to study needs — no overpayment
MEASURABLE PERFORMANCE
-
> 40%
AVERAGE REDUCTION IN eCRF DEPLOYMENT TIME
Thanks to ready-to-use modules
-
100%
PROJECTS PASS REGULATORY AUDITS
With no critical data findings
-
< 24h
AVERAGE RESPONSE TIME TO DATA REQUESTS
Enabled by integrated
monitoring systems -
24/7
ACCESS TO DASHBOARDS
For real-time, data-driven decisions
FREE PERSONALIZED
SYSTEM DEMO
IN JUST 30 MINUTES, WE WILL SHOW YOU:
- Real-time dashboards using your data structure
- Our quick-start templates
- Preliminary streamlining guidelines for your current processes
