EDC Design
Rapid deployment of validated eCRF forms with comprehensive edit checks ensuring data quality from day one.
Clinical Data Management
Expert data management from first patient in to database lock.
Get in Touch 
What we can do
Medical Coding
AI-Accelerated Medical Coding with Expert Oversight.
Data Validation
Robust edit check programming and systematic SAE reconciliation to ensure complete, accurate datasets.
Database Lock Support
Streamlined lock process with multi-tier QC review ensuring audit-ready, submission-quality data.
Expert data management from first patient in to database lock.
We deliver validated EDC systems, comprehensive documentation, and real-time quality metrics throughout your clinical trial. From database design to lock, our solutions include change tracking, protocol deviation monitoring, and regulatory-compliant data packages ensuring inspection readiness.
What we offer
Systems & Tools
- Validated EDC Platform with Custom Configuration
- Real-time Dashboard & Progress Tracking
- Automated Query Management System
Documentation Package
- Complete Regulatory Documents (DMP, DVS, DVP)
- CRF Completion Guidelines
- Audit Trail & Compliance Certificates
Quality Deliverables
- Protocol Deviation Reports
- Data Quality Metrics & Trends
- External Data Reconciliation Results
Final Data Package
- Clean, Submission-Ready Datasets
- Data Transfer with Full Change Log
- Complete Archive with Metadata
Service Guarantee
- Dedicated Project Team
- Rapid Issue Resolution
- Inspection Readiness Support
Service Category 1Study Setup & Build Services
- Protocol Review & CRF Design
- Database Build & Configuration
- Edit Check Programming
- UAT & System Validation
Service Category 2Data Operations Services
- Site Training & Support
- Data Entry Assistance
- Query Management
- Medical Coding (MedDRA/WHODrug)
Service Category 3Data Quality & Compliance Services
- Data Cleaning & Review
- CDISC Standards Implementation
- 21 CFR Part 11 Compliance
- Risk-Based Monitoring Support
Service Category 4Data Delivery & Close-Out Services
- Database Lock Procedures
- Data Export & Transfer
- Archive & Regulatory Submission Support
Service Category 5Ongoing Support Services
- 24/7 Technical Helpdesk
- System Maintenance & Updates
- Protocol Amendment Management
- Additional Training Programs
How We Engage
A streamlined 4-step approach to clinical excellence.
1
Discovery & Planning
Week 1-2
- Initial consultation & needs assessment
- Protocol review & feasibility analysis
- Resource planning & timeline development
- Risk assessment & mitigation strategy
2
Setup & Configuration
Week 3-6
- EDC platform selection & setup
- Database design & eCRF development
- Edit check programming
- UAT & system validation
3
Execution & Monitoring
Ongoing
- Site training & go-live support
- Real-time data monitoring
- Query management & resolution
- Continuous quality improvement
4
Delivery & Close-out
Final Month
- Database lock procedures
- Clean data delivery
- Archive preparation
- Regulatory submission support
Ready to accelerate your clinical program?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Submit RFP Clinical Data Management
Expert data management from first patient in to database lock.
Get in Touch What we can do
EDC Design
Rapid deployment of validated eCRF forms with comprehensive edit checks ensuring data quality from day one.
Medical Coding
AI-Accelerated Medical Coding with Expert Oversight.
Data Validation
Robust edit check programming and systematic SAE reconciliation to ensure complete, accurate datasets.
Database Lock Support
Streamlined lock process with multi-tier QC review ensuring audit-ready, submission-quality data.
Expert data management from first patient in to database lock.
We deliver validated EDC systems, comprehensive documentation, and real-time quality metrics throughout your clinical trial. From database design to lock, our solutions include change tracking, protocol deviation monitoring, and regulatory-compliant data packages ensuring inspection readiness.
What we offer
Systems & Tools
- Validated EDC Platform with Custom Configuration
- Real-time Dashboard & Progress Tracking
- Automated Query Management System
Documentation Package
- Complete Regulatory Documents (DMP, DVS, DVP)
- CRF Completion Guidelines
- Audit Trail & Compliance Certificates
Quality Deliverables
- Protocol Deviation Reports
- Data Quality Metrics & Trends
- External Data Reconciliation Results
Final Data Package
- Clean, Submission-Ready Datasets
- Data Transfer with Full Change Log
- Complete Archive with Metadata
Service Guarantee
- Dedicated Project Team
- Rapid Issue Resolution
- Inspection Readiness Support
Service Category 1
Study Setup & Build Services
- Protocol Review & CRF Design
- Database Build & Configuration
- Edit Check Programming
- UAT & System Validation
Service Category 2
Data Operations Services
- Site Training & Support
- Data Entry Assistance
- Query Management
- Medical Coding (MedDRA/WHODrug)
Service Category 3
Data Quality & Compliance Services
- Data Cleaning & Review
- CDISC Standards Implementation
- 21 CFR Part 11 Compliance
- Risk-Based Monitoring Support
Service Category 4
Data Delivery & Close-Out Services
- Database Lock Procedures
- Data Export & Transfer
- Archive & Regulatory Submission Support
Service Category 5
Ongoing Support Services
- 24/7 Technical Helpdesk
- System Maintenance & Updates
- Protocol Amendment Management
- Additional Training Programs
How We Engage
A streamlined 4-step approach to clinical excellence.
1
Discovery & Planning
Week 1-2
- Initial consultation & needs assessment
- Protocol review & feasibility analysis
- Resource planning & timeline development
- Risk assessment & mitigation strategy
2
Setup & Configuration
Week 3-6
- EDC platform selection & setup
- Database design & eCRF development
- Edit check programming
- UAT & system validation
3
Execution & Monitoring
Ongoing
- Site training & go-live support
- Real-time data monitoring
- Query management & resolution
- Continuous quality improvement
4
Delivery & Close-out
Final Month
- Database lock procedures
- Clean data delivery
- Archive preparation
- Regulatory submission support
Ready to optimize your clinical trial?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Submit RFP