Best Of Your Growth, Our Mission
Transform Data into Regulatory-Grade
Insight
In life sciences, data isn’t just information — it’s evidence. From clinical trials to regulatory submissions, the quality, structure, and compliance-readiness of your data can accelerate or stall your progress.
At Agile Genix, we engineer robust clinical data management and analytics solutions tailored for pharmaceutical, biotech, and CRO environments. Our frameworks are designed to meet the demands of complex, multi-site, and multi-phase studies — while staying aligned with global regulatory requirements.
Clinical Data Services
Transform Data into Regulatory-Grade Insight
End-to-End Clinical Data Management (CDM)
- eCRF design, validation, and database build
- Real-time data capture and remote data monitoring
- Query management and discrepancy resolution
- Medical coding (MedDRA, WHO-DD) integration
- CDISC SDTM conversion and archival
Outcome: Structured, validated datasets with traceable audit history and submission-ready formats.
Advanced Clinical Analytics
- Real-time dashboards for patient progress and protocol adherence
- Trend analysis and anomaly detection
- Statistical data exploration for interim insights
- Integration of lab, imaging, and biometric data streams
Outcome: Enhanced trial visibility and faster decision-making through centralized data intelligence
Regulatory Data Preparation & Submissions
- Mapping to CDISC standards (SDTM, ADaM)
- Dataset generation for FDA/EMA submissions
- Submission package creation aligned with eCTD
- Data anonymization and patient privacy compliance
Outcome: Fully formatted, regulator-compliant submissions with reduced manual rework and faster approval cycles.
Data Transformation & Integration
- ETL pipelines for multi-source clinical data (EDC, CTMS, LIMS, IVRS)
- Real-world data (RWD) ingestion and normalization
- Integration with Medidata, Oracle Clinical, Veeva, and custom platforms
- Centralized data lakes for large-scale studies
Outcome: A unified, query-ready data ecosystem that supports both operational excellence and regulatory scrutiny.
Built for Compliance .Designed to Scale.
Our solutions align with global data governance and regulatory standards:
- 21 CFR Part 11, ICH E6(R2), GxP, HIPAA, GDPR
- CDISC, SDTM, ADaM, MedDRA
- Validated data pipelines and audit-ready systems
- Secure cloud or hybrid deployment models (AWS, Azure, GCP)
Why Agile Genix?
Clinical and Technical Expertise
We blend deep clinical trial operations knowledge with enterprise-grade data engineering — ensuring domain accuracy and technical excellence.
- Regulatory-Centric Approach
Our systems are built for inspection-readiness, traceability, and long-term data integrity.
- Speed with Precision
Accelerate your trial timelines without compromising compliance, accuracy, or data visibility.
- Global Scalability
Support for multinational trials, cross-platform integrations, and centralized reporting for sponsors and regulators.
Real- World Impact
Reduced database lock timelines by 30% across Phase II & III trials
Enabled 100% CDISC-compliant data submissions to FDA and EMA
Delivered integrated dashboards across 6+ trial platforms
Created a centralized data lake that streamlined 7 global studies
Turn Data Complexity into Clinical Clarity
Clinical data drives every major milestone in drug development. Let Agile Genix help you build the foundation that ensures quality, accelerates timelines, and meets the highest standards of integrity.