AI-MED eSource Hub

Site-Controlled eSource Workspace for rSDV

Limitations of the On-Site SDV

Traditional on-site source data verification presents significant operational challenges that impact trial efficienty, site relationships and overall data quality management in modern clinical research.

E

Delayed Data Access

Crucial data remains unavailable until the next monitoring visit, severely limiting the ability to manage sites in real-time, uncover issues, and identify bottlenecks that could compromise trial integrity and patient safety.

E

Scheduling Disruptions

On-site visits are challenging to schedule and disruptive to the site’s day-to-day operations, interfering with patient care activities and requiring extensive coordination between multiple stakeholders.

E

Infrequent Verification

On-site SDV couldn’t be done regularly and frequently since it is possible only during expensive and time-consuming on-site visits, creating gaps in data oversight and quality monitoring capabilities.

AI-MED eSource Hub Functionalities

  1. 1. Query Communication Tracking.
    Tracks the detailed, back and forth query communications between a study site and monitor when reviewing source documents supporting source data verification (SDV) and source data review (SDR).
  2. 2. Automated Query Generation.
    Upon review of source documents, monitors can generate relevant queries in the eCRF that are automatically notified to the investigator, ensuring rapid communication and resolution.
  3. 3. Intelligent Document Organization.
    Source documents are organized by patient’s code and flagged by verification status for streamlined navigation and oversight.

Reviewed with queries pending

Reviewed without issues

Reviewed with queries solved

No review required

AI-MED eSource Hub Security & Compliance

Advanced Encryption
All transactions are encrypted with comprehensive audit trail of activities, ensuring complete transparency and security for all platform interactions.

21 CFR Part 11 Validation
Validated according to 21 CFR Part 11 requirements, meeting stringent FDA standards for electronic records and electronic signatures.

GDPR Compliance
Fully GDPR compliant with Data Protection Impact Assessment (DPIA) available, ensuring European data protection regulation adherence.

Privacy Protection
No risk of data privacy breach since all patient’s clinical data remain within the full and only control of the investigative site.

AI-MED eSource Hub Benefits

E

Site-Controlled Workspace

A single study-specific eSource workspace under the full control of the site staff, ensuring autonomy and operational efficiency.

E

Multi-Purpose Access

Uploaded documents can be made available also for remote audits and/or inspections, streamlining regulatory oversight processes.

E

Independent Operations

Investigator and CRA can operate independently, increasing flexibility and continuity in SDV while eliminating the monitoring backlog.

E

Expedited Verification

Accelerated source verification in case of SAE/SUSAR and major protocol deviations, ensuring rapid response to critical events.

E

Detailed Documentation

SDV objectively documented and detailed, providing comprehensive records for regulatory review and audit trails.

E

Reduced On-Site Visits

Significantly reduced on-site monitoring visits, decreasing travel expenses and site disruption while maintaining data quality.

All Our Services

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GenAI-Driven Synthetic Control Arm

9

GenAI-Driven RWD Acquisition & Analysis

9

Target Trial Emulation for Drug Repurposing

9

Realistic and Privacy-guarantees Synthetic Patient Data

9

AI-MED Documenta

9

AI-MED eSource Hub

9

AI-MED TrialSafety

9

GenAI-Driven Remote Verbal Consent

CONTACT DETAILS

info@aimedtrial.com

+39 3482630229