Clinical Data Studio
Transform data complexity into efficiency with automation, AI, and real-time insights
The clinical trial landscape is evolving rapidly, with exponential growth in data volume and complexity, creating significant challenges across processes, resources, and system landscapes. Today’s clinical trials generate an unprecedented amount of data, making the tasks of ingesting, standardising, transforming, and analysing this information increasingly intricate and resource-intensive.
The tasks of ingesting, standardising, transforming, and analysing massive volumes of clinical data have become increasingly complex, necessitating advanced solutions to manage this growing burden effectively.
Clinical Data Studio unifies data from multiple sources, streamlining processes through automation and delivering real-time, actionable insights. As a comprehensive solution, ICON has implemented Clinical Data Studio to enhance efficiencies and accelerate clinical discovery across diverse cross-functional teams. The platform supports a wide range of use cases, including clinical data science, central monitoring, clinical operations, medical monitoring, clinical programming, and other critical data-driven functions. By automating repetitive tasks and integrating disparate data sources, Clinical Data Studio empowers teams with greater agility, improved data quality, and enhanced decision-making capabilities.
Key benefits
Enhanced sponsor oversight and direct data access
Gain a shared, real-time view of clinical data to proactively detect anomalies, mitigate risks, and respond to insights with greater speed and confidence.
Automated data flows & standards
ICON has developed and implemented automated data flows and standardised processes, ensuring greater efficiency, consistency, and scalability in clinical data science. This improves quality, enhances compliance, and overall study execution.
Strategic partnership & ICON expertise
ICON assessed the market and chose to be an early adopter of Clinical Data Studio. As a trusted partner of Medidata, ICON brings 13 + years of risk-based data review knowledge to the close collaboration with the Medidata team, actively influencing the platform's roadmap and innovation. This partnership ensures that ICON remains at the forefront of technological advancements, driving solutions tailored to evolving industry needs.
End-to-end single platform/experience
With Clinical Data Studio, multi-source data is seamlessly integrated, transformed, and analysed within a single platform. This reduces operational burden, improves data visibility, streamlines communication, shortens timelines, mitigates risks, and enhances patient safety.
Real-time actionable data review insights
Built with a user-friendly, no/low-code environment, Clinical Data Studio leverages automation and AI to optimise data aggregation, standardisation, and data review workflows. Multiple users can collaborate on real-time data, accelerating decision-making, optimize cycle times, and ensuring high-quality data.
Prompt availability of data review listings
ICON has established standardized, reusable outputs that streamline study setup and post FPI availability. Once created, data review listings and data mappings can be replicated across studies, enabling faster deployment with reduced validation requirements, accelerating readiness for First Patient In (FPI)
Accomplish compliance with regulatory requirements (QTLx & KRIs)
As dictated by ICH E6 guidelines, which protects trial participants and reliability of trial results.
Key Features
Automated data ingestion and integration
Integrate data from EDC, external data, sensors, and eCOA systems seamlessly to eliminate bottlenecks caused by disconnected systems.
Low-code/no-code functionality
Empower study teams to generate and manage datasets with minimal programming expertise, improving productivity and flexibility.
Real-time insights
Access a unified view of data in real time to monitor patient profiles, safety signals, and risk metrics without delays.
Automated reconciliation
Reduces manual data review time and enhances data accuracy by automating clinical data reconciliation. This AI-driven Natural Language Processing (NLP) tool can focus on high priority, time-consuming reconciliations such as adverse events (AEs) and concomitant medications (CMs).
Automated querying
Programmatic analysis identifies potential issues and inconsistencies, allowing queries to be raised directly into EDC from Clinical Data Studio.
Comprehensive platform
More than just data review—our solution offers streamlined issue management, integrated risk assessment, and a dedicated vendor query portal to facilitate seamless third-party vendor reconciliation.
Prompt availability of standardised data review outputs
Minimal configuration, allowing for quick adoption and immediate impact.