Accelerate drug development with advanced analytics and AI to extract actionable insights from diverse real-world data sources. Our solutions empower pharma organizations to design robust RWE studies, optimize market access, and drive clinical innovation.
Integrate advanced AI/ML for robust predictive analytics and evidence generation, directly supporting regulatory requirements and clinical claims.
Harmonize and meticulously analyze multi-source RWD to build comprehensive patient profiles and demonstrate treatment effectiveness in real-world settings.
Ensure regulatory-compliant RWE study execution, adhering to global standards for evidence generation and data integrity.
Enable rapid cohort identification and rigorous comparative effectiveness analysis critical for demonstrating value to health authorities.
Streamline the clinical data lifecycle using next-generation technologies and analytics platforms. Our AI-powered solutions ensure data integrity, regulatory compliance, and faster trial timelines for pharmaceutical and biotech companies.
AI-Driven Automation
Automate data collection, validation, and cleansing using AI-driven solutions, minimizing human error and enhancing data quality for regulatory scrutiny.
Secure Data Infrastructure
Deploy secure, cloud-based EDC systems and centralized data lakes for seamless data access and robust audit trails, meeting stringent regulatory demands.
Real-Time Monitoring
Utilize advanced analytics for real-time data quality monitoring, proactively identifying and resolving discrepancies to maintain compliance throughout a study.
Compliance-Ready Systems
Ensure strict regulatory compliance (e.g., 21 CFR Part 11) through automated workflows and comprehensive audit trails, critical for inspection readiness.
Ensure seamless regulatory submissions to global authorities (e.g., FDA, PMDA) by transforming clinical data into CDISC-compliant formats.
SDTM & ADaM Transformation
Specialize in the implementation and conversion to key CDISC standards, including SDTM (Study Data Tabulation Model) for data organization and ADaM (Analysis Data Model) for statistical analysis.
CDASH Standardization
Utilize CDASH (Clinical Data Acquisition Standards Harmonization) to standardize data collection at the source, improving data quality and reducing inconsistencies.
Define-XML & Metadata
Generate Define-XML, support Controlled Terminology mapping and associated metadata to provide clear, machine-readable documentation of dataset structures, critical for regulatory review.
Traceability & Audits
Facilitate data traceability from raw data to analysis datasets and final reports, meeting rigorous audit and inspection requirements.
Strengthen operational oversight and ensure clinical trial excellence with advanced analytics and AI-powered monitoring.
Risk Mitigation Strategy
Mitigate operational risks and ensure high-quality outcomes with sophisticated analytics and AI-driven monitoring. Our platforms enable proactive risk identification and continuous quality improvement throughout clinical development.
Early Risk Detection
Implement predictive analytics for early risk detection in clinical trials, allowing for proactive intervention and minimizing study delays or deviations.
Protocol Monitoring
Utilize process mining to monitor protocol adherence and identify process inefficiencies or compliance gaps, ensuring study integrity.
Real-Time Dashboards
Automate quality assurance with real-time dashboards, providing immediate visibility into critical quality metrics and potential issues.
AI-Driven Oversight
Integrate AI for continuous monitoring and adaptive corrective action planning, ensuring robust quality management systems throughout trials.
Ensure the reliability and compliance of clinical and R&D systems using advanced validation technologies. Our end-to-end validation services leverage AI and automation to minimize risk and accelerate innovation.
Automate validation testing and documentation with AI-powered tools, significantly reducing validation timelines and ensuring
Guarantee regulatory compliance for both cloud-based and on-premise systems, navigating complex regulatory landscapes (e.g., GxP, Annex 11).
Leverage analytics to detect and swiftly resolve system deviations, ensuring ongoing system performance and data integrity.
Maintain continuous validation with real-time change impact analysis, providing an agile approach to system updates and ensuring perpetual compliance.