Clinical Data Management

We deliver AI-enabled clinical data management solutions that ensure high-quality, compliant, and reliable clinical trial data—while reducing timelines and operational costs. From CRF design and EDC system setup to database lock, we manage the complete clinical data lifecycle with precision and efficiency.

Our data management framework leverages automation, advanced analytics, and intelligent data validation to accelerate data cleaning, enhance accuracy, and ensure full traceability. By defining and documenting robust processes upfront, we maintain data integrity and regulatory compliance throughout the study. We work with 21 CFR Part 11–compliant EDC platforms and design intuitive eCRF and ePRO solutions, enabling real-time data capture directly from sites and patients via secure digital and mobile technologies.

Our Data Management capabilities include:

• Intelligent Database Design & Planning: AI-assisted database design with digitally enabled Data Management Plans (DMP) and Data Validation Plans (DVP) to optimize data flow, minimize errors, and ensure regulatory compliance from study start-up.
• Smart eCRF & ePRO Development: Rapid planning, setup, validation, and deployment of eCRF and ePRO using automated edit checks, AI-driven logical validations, and real-time data capture for faster, cleaner data.
• Digital Investigator & Site Training: Interactive, technology-enabled training for investigators and sites on eCRF/ePRO usage, supported by digital guides and role-based data entry workflows to improve adoption and data quality.
• AI-Driven Data Review, Analytics & Monitoring: Continuous data review powered by AI-based anomaly detection, automated query generation, and predictive consistency checks, with real-time dashboards and reports to support monitors, and data monitoring committees.
• Accelerated Database Close-Out: Streamlined close-out activities using automation and advanced analytics for file documentation, faster database lock, and secure, compliant data export.

We support Phase I–IV clinical trials, Real-World Evidence (RWE) studies, Post Marketing Studies and Pharmacovigilance, transforming raw data into accurate, meaningful, and regulatory-ready insights. With deep expertise across EDC, eTMF, ePRO, and CTMS platforms, our integrated, technology-driven delivery model delivers end-to-end visibility, scalability, and success—even for the most complex global studies.