As clinical research becomes increasingly complex and decentralised, sponsors and CROs are under pressure to ensure that their data collection processes are accurate, compliant, and efficient. This shift has placed eSource data capture-the direct collection of electronic data at the point of care-at the centre of modern trials.
At Xolomon, we believe that integrating eSource capabilities into your electronic Clinical Research Document (eCRD) system is not just a technical upgrade-it’s a strategic advantage. But to unlock its full potential, digital data capture must follow well-defined best practices.
What is eSource and why does it matter?
eSource refers to any electronic data that is directly captured from the source during a clinical trial-without the need for paper or manual transcription. This can include data from digital forms, wearable devices, clinical lab systems, or electronic medical records (EMRs).
Compared to traditional data entry methods, eSource with eCRD offers significant benefits:
- Improved data quality and accuracy
- Reduced transcription errors and protocol deviations
- Faster data availability for review and decision-making
- Streamlined regulatory compliance with audit-ready records
Best practices for eSource with eCRD platforms like Xolomon
1. Design your eCRD with the source in mind
The eCRD should be structured to reflect the real-world data flow at research sites. This includes aligning form fields with clinical routines, minimising duplicate entry, and capturing only essential, protocol-relevant data.
At Xolomon, we offer flexible eCRD templates that adapt to each study’s design-simplifying workflows for investigators and improving data consistency.
2. Implement automated validations
Build-in real-time logic checks to catch missing or out-of-range values as they are entered. This prevents data discrepancies and reduces the burden of query resolution during monitoring visits.
With Xolomon’s platform, users can configure customised validation rules for each field or form section, ensuring data integrity from day one.
3. Enable role-based access and audit trails
Regulatory authorities such as the FDA and EMA require transparent documentation of who did what, when, and why. Your eCRD system must support secure user permissions and automatically log all actions for full GCP compliance.
Xolomon provides detailed audit trails and role-based access controls, so your data is always traceable and inspection-ready.
4. Support integration with external data sources
To truly benefit from eSource, your eCRD should integrate with other systems such as EMRs, lab data feeds, or ePRO devices. This ensures consistency and avoids unnecessary duplication.
Xolomon’s interoperable platform allows for smooth API-based data exchange, helping sponsors centralise and harmonise study data.
5. Train site staff and monitor usage
Even the best eCRD platform depends on proper usage. Providing intuitive interfaces, clear SOPs, and training ensures adoption and compliance across all sites.
Our team at Xolomon works closely with sites to ensure smooth onboarding and continuous support throughout the trial lifecycle.
Xolomon: making research accessible
Digital data capture through eSource is no longer optional-it’s essential for running efficient, compliant, and high-quality clinical trials. By following these best practices and leveraging a robust eCRD system like Xolomon, sponsors and CROs can reduce risk, speed up timelines, and improve trial outcomes.
