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Accelerate Your Clinical Trials with Clinion EDC: Unleashing the Power of AI & Automation
- Rajesh S Pothula
- June 27, 2023

On this Page
- Summary
- eProtocol Automation - Accelerating Protocol Design and Execution
- Global Libraries - Standardization and Harmonization Made Easy
- AI Medical Coding - Enhancing Efficiency and Accuracy
- Remote SDV Automation - Enhancing Efficiency and Compliance
- Conclusion
- Summary
- eProtocol Automation - Accelerating Protocol Design and Execution
- Global Libraries - Standardization and Harmonization Made Easy
- AI Medical Coding - Enhancing Efficiency and Accuracy
- Remote SDV Automation - Enhancing Efficiency and Compliance
- Conclusion
Summary
Electronic Data Capture (EDC) software has revolutionized clinical trials, enabling clinical research teams to streamline data management and enhance operational efficiency. However, the true potential of EDC is realized when coupled with advanced features that leverage AI and machine learning (ML). Among the sea of options, Clinion EDC stands out as a game-changer.
Discover how Clinion EDC’s advanced AI-enabled features like eProtocol Automation, Global Libraries, AI Medical Coding, and Remote SDV Automation set it apart from the competition, making it the ideal choice for accelerating your trials.
eProtocol Automation - Accelerating Protocol Design and Execution
Complementing its existing EDC capabilities, Clinion brings eProtocol Automation, enabling CROs and pharma companies to streamline protocol design and execution. This feature revolutionizes the creation, modification, and deployment of protocols, offering an intuitive interface and AI-driven suggestions.

Users can generate the entire Protocol for a study in 3 quick steps:
Step 1: Users need to just upload the Protocol Synopsis to Clinion’s eProtocol Automation tool for it to generate the entire Protocol.
Step 2: Users can then review the Protocol and make changes as required.
Step 3: The user can then commit the finalized eProtocol to the database.
Weeks of effort and coordination can be reduced to a few days. Clinion utilizes the power of Generative AI to make this possible.
Global Libraries - Standardization and Harmonization Made Easy
Global Libraries in Clinion act as a centralized repository for study-specific data elements, forms, and even entire study designs. By leveraging Global Libraries, CROs can achieve consistent data collection and harmonization across multiple trials and sites.
A study can be set up in a matter of days by utilizing Clinion EDC’s Global Libraries.
Step 1: Users can simply copy the required forms and/or pages over to a new study.
Step 2: The forms, edit checks, and skip logic checks are simply copied over to the new study, allowing users to validate the study and make it live.
Step 3: Users can also copy an entire study over and modify the forms, and make it live!
AI Medical Coding - Enhancing Efficiency and Accuracy
As an add-on benefit, Clinion EDC introduces AI Medical Coding, augmenting the core EDC functionalities. This AI-powered feature automates the complex and time-consuming process of medical coding of clinical trial data, significantly reducing manual efforts while maintaining high accuracy.
AI Medical Coding comes as a default in Clinion EDC, augmenting traditional auto and manual coding methods. Users can use AI Medical Coding as they would use traditional coding, without additional training or learning needs.
By harnessing advanced machine learning algorithms, AI Medical Coding ensures swift and precise assignment of medical terms to collected data, empowering Clinical research teams with faster coding insights, improved data quality, and more efficient decision-making.
Remote SDV Automation - Enhancing Efficiency and Compliance
Clinion EDC’s rSDV Automation feature empowers clinical research teams to automate source data verification remotely. Through AI-powered algorithms, Clinion AI identifies and verifies EDC data with source data, reducing the need for on-site visits. Site Users can redact and upload Source Documents into Clinion EDC. This innovative functionality not only saves time and resources but also enhances data quality, ensures compliance with regulatory guidelines, and enables CROs to make data-driven decisions more efficiently.
Additionally, Clinion EDC software offers an array of regular EDC features such as Interactive Dashboards, Custom Reports, Local Labs Integration, Version Management, eCRF Locks, and Bulk Locks, further enhancing the overall user experience and ensuring seamless trial management.
Conclusion
Clinion EDC, with its advanced AI-enabled features like AI Medical Coding, eProtocol Automation, Global Libraries, and Remote SDV Automation, unlocks the true potential of electronic data capture for Clinical research teams. By seamlessly integrating these additional benefits with essential EDC functionalities, Clinion EDC System revolutionizes the way clinical trials are conducted.
Moreover, Clinion’s commitment to innovation is evident as they continue to develop and introduce new AI use cases, aimed at making clinical trials even easier and more efficient. Experience the transformative power of Clinion EDC and stay at the forefront of cutting-edge advancements in the industry.

A marketing leader with a sharp focus on strategic clarity, positioning, and GTM alignment. At Clinion, he drives marketing initiatives that connect narrative precision with measurable growth, ensuring the company’s AI-powered innovations resonate deeply across the life sciences industry.
FAQS
Frequently Asked Questions
AI-enabled EDC systems leverage AI, machine learning, and Gen AI to automate repetitive, resource-intensive processes in clinical trials. This reduces manual effort, accelerates timelines, and enhances the consistency and quality of trial data.
eProtocol automation streamlines protocol drafting by using AI to generate a complete draft from a protocol summary. Instead of writing protocols manually, you simply upload a summary, review the AI-generated draft, and make edits as needed. This reduces the effort involved and can cut protocol development timelines from weeks to just a few days.
Global libraries are standardized repositories of commonly used forms, data elements, edit checks, and logic. They help teams build new studies quickly by reusing pre-validated components. This ensures consistency across trials, reduces setup time, and minimizes errors caused by creating forms from scratch.
AI medical coding automates the process of assigning medical dictionary codes (like MedDRA or WHO-DD) to collected data. It uses trained models to suggest or auto-apply codes based on previous coding patterns. This reduces time spent on manual coding, improves consistency, and allows coders to focus on edge cases instead of routine terms.
Remote SDV automation allows clinical monitors to verify data without visiting the site physically. Site teams upload source documents to the system, which uses AI to compare those with the corresponding EDC entries. The system flags discrepancies, allowing faster resolution and reducing monitoring costs while improving accuracy and audit readiness.
Integration eliminates silos by allowing real-time data exchange across systems. For example, ePRO data flows directly into the EDC, reducing duplication and entry errors. CTMS integration ensures smoother site and visit tracking, while RTSM integration syncs patient enrollment and drug dispensation. Together, these integrations create a unified workflow, reduce manual work, and improve decision-making with a centralized data view.
Yes. Leading AI-powered EDC systems are built to comply with global regulatory requirements such as FDA 21 CFR Part 11, GDPR, ICH GCP, and EU Annex 11. The AI components are validated as part of the system’s overall software validation, ensuring auditability, data integrity, and adherence to industry standards.
The future of AI in EDC includes predictive analytics, automated risk-based monitoring, AI-assisted data cleaning, and adaptive form design. These innovations will help sponsors identify trends early, respond faster to risks, and build studies that adjust in real-time—bringing us closer to fully intelligent clinical trial ecosystems.
Still have questions?
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Compliance
Fully Compliant with Global Standards

