Clinion EDC

What is Clinion EDC?

Clinion EDC is an advanced, AI-native Electronic Data Capture (EDC) software designed specifically for the clinical trials industry. It serves as a comprehensive platform to drive down trial costs while simultaneously ensuring superior data quality, accelerating study builds, and optimizing overall operational efficiency. Engineered to support clinical trials across all phases (I to IV), Clinion EDC provides a unified and intelligent environment for data collection, management, and review, making it a pivotal tool for biotech companies, pharmaceutical organizations, and contract research organizations (CROs).

The core purpose of the software is to replace traditional, paper-based data collection methods with a streamlined, digital workflow. By leveraging artificial intelligence, it automates and simplifies complex processes, from initial study setup to final database lock, ensuring data integrity and compliance throughout the trial lifecycle.

Why Choose Clinion EDC?

• Industry-Leading AI Capabilities: Clinion incorporates the most extensive AI suite in the clinical trials sector. This technology is not just an add-on; it's a core component that accelerates study builds, enhances data management and review processes, and facilitates a smoother study close-out. The result is a marked improvement in data quality, greater efficiency, and a substantial reduction in overall trial costs.
• Unified and Seamless Integration: The platform operates within a unified data ecosystem, ensuring seamless integration with other critical clinical trial modules. This includes Randomization and Trial Supply Management (RTSM), electronic Patient-Reported Outcomes (ePRO), Clinical Trial Management System (CTMS), eConsent, and eSource. This interconnectedness provides a streamlined user experience and consolidated data visibility, eliminating data silos.
• Fastest Study Setup in the Industry: Time is a critical factor in clinical research. Clinion addresses this with the industry fastest study build capabilities. By utilizing codeless, standardized global libraries, study configuration can be completed in less than two weeks, a significant reduction compared to traditional methods. This rapid deployment allows research to commence sooner, accelerating timelines from start to finish.
• Regulatory-Grade Compliance: Clinion EDC is fully compliant with ISO 9001 and ISO 27001, 21 CFR Part 11, EU Annex 11, and ICH GCP, with product design aligned to GAMP 5 for risk-based system validation.

Advanced Features of Clinion EDC

• Accelerated Study Setup: Deploy studies in weeks without any programming. The platform's Standardized Global Library offers pre-built, CDASH-compliant templates for various therapeutic areas. Users can instantly duplicate forms and customize elements like edit checks and skip logic, achieving an average go-live timeline of 2-4 weeks and a 50% reduction in operational build costs.
• Instant Discrepancy Detection: The award-winning AI Data Review feature empowers data managers to identify and resolve data discrepancies instantly. Using natural language prompts, they can create custom datasets, flag issues, and issue bulk queries or corrections across all affected subjects with a single action. This leads to a 40-50% faster time to database lock and similar savings in total data management costs.
• Real-Time Post-Production Changes: Mid-study changes to visits, pages, or fields can be applied to live studies with zero downtime. Automatic version control protects existing data, and reports always pull from the latest CRF version, eliminating manual reconciliation and saving up to 40% in time and costs.
• Audit-Ready Reports in Seconds: Users can schedule automated notifications, maintain full audit trails with version history, and push data to third-party tools via secure APIs, achieving 80-90% faster report generation and a 75-85% reduction in reporting costs.
• Automated CDISC Compliance: The AI engine simplifies compliance by mapping variables to CDASH standards in minutes. It provides annotated mapping suggestions that users can review, customize, or accept, reducing coding effort by 40% and ensuring studies are set up according to industry standards more quickly.
• Instant AI-Powered Support: CliniBot, an integrated AI-conversational bot, provides instant support via chat. It helps resolve user issues quickly and efficiently, reducing reliance on external help desks and minimizing delays.

Modules of Clinion EDC

• RTSM (Randomization and Trial Supply Management)
• ePRO (Electronic Patient-Reported Outcomes)
• CTMS (Clinical Trial Management System)
• eConsent (Electronic Consent)
• eSource (Electronic Source Data)

How to Use Clinion EDC?

1. Study Configuration: Begin by using the codeless global library and pre-built templates to configure the study. Customize forms, edit checks, and workflows to match the protocol's specific requirements, all within a rapid, two-to-four-week timeframe.
2. Data Entry and Management: Once the study is live, site staff can begin entering data into the intuitive electronic Case Report Forms (eCRFs). Data managers can then use the AI Data Review tool to monitor data quality in real-time.
3. Discrepancy Resolution: The AI engine automatically flags potential discrepancies. Data managers can review these flags, issue queries in bulk, and resolve issues directly within the platform, drastically reducing the data cleaning cycle.
4. Reporting and Oversight: Generate custom reports on demand using simple natural language prompts. Schedule automated report delivery to stakeholders to maintain oversight of trial progress, safety, and data quality.
5. Database Lock: With cleaner data and faster discrepancy resolution throughout the trial, the process of achieving a final, clean database for analysis is significantly accelerated, leading to a faster study close-out.

Clinion EDC Pricing

Clinion EDC pricing details are available on request on techjockey.com.

The pricing model is based on different parameters, including extra features, deployment type, and the total number of users. For further queries related to the product, you can contact our product team and learn more about the pricing and offers.