Clean, connected, and compliant clinical data systems
Clean, connected, and compliant clinical data systems
Connected systems
Harmonized data
Enable seamless clinical trial data flow and interoperability across clinical and portfolio systems, including Clinical Data Management Systems (CDMS/EDC), Clinical Trial Management Systems (CTMS), Project & Portfolio Management (PPM) systems, Risk Based Quality Monitoring systems (RBQM) and Safety systems.
Implement and optimize clinical data systems to support data and process efficiency.
Eliminate manual trackers by automating routine workflows and building lightweight digital tools.
Design scalable architectures to standardize and harmonize clinical data across systems.
Visualized insights
AI & Automation
Apply AI/ML and Gen AI to enhance decision-making, automate reporting, and optimize trial execution.
Analyze and visualize data to deliver actionable insights across clinical trial data and systems.
Develop compliant analysis-ready datasets and statistical outputs using SAS, R, and Python.
We address the core inefficiencies in modern clinical trials, moving from reactive problem-solving to proactive data intelligence.
ReworkDelaysBlind spotsMistrustEmbed accuracy and reliability into every stage of clinical data management, so integrity isn’t checked later; it’s built in from the start enabling data integrity by design.
Manual workaroundsErrorsInefficiencyFatigueCompliance issuesConnect systems, eliminate silos and spreadsheets, and deliver faster, clinical data analytics, so clinical teams make smarter decisions via Clinical Data Science.
Static reportsManual diggingNo access to right data Turn harmonized data into real-time dashboards, enabling study teams to spot trends, quality risks, enrollment delays, site gaps, and safety signals without spreadsheets.
Reactive decision makingManual standardizationMissed improvementsUse AI to automate clinical data management process and flag issues early, automate checks, speed data cleaning, strengthen compliance, while keeping sites and data managers in the loop.
Our engagements are guided by subject matter experts with deep clinical trial and data management expertise, enabling the design of inspection-ready data architectures with well-defined standards, metadata models, and risk-based controls.
We establish robust, scalable frameworks to ensure end-to-end clinical data integrity, standardized validation processes, and sustained compliance with GxP and 21 CFR Part 11 requirements across platforms and programs.
Our delivery is powered by skilled, certified professionals across Dataiku, Veeva, Databricks, and REDCap Cloud, ensuring high-quality implementation across clinical and analytics platforms.
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