A major component of eSource technology at the site is the ability to capture clinical data in real-time during the patient visit through an eSource data capture system. The benefits of capturing data in real-time electronically are many fold for both the sites and sponsors. They include:
- No point of entry or transcription errors
- True remote monitoring of source
- No Source Data Verification (SDV)
- Significantly reduced travel cost
- Continuous review of data
- Focus more on the study and patients
- Proactive corrections, less deviations
- Clean, code, review data in real-time
- Less queries, increased DM efficiency
- Focus on clinical review vs clerical review
- Accelerated DB lock
These benefits are impossible to achieve with traditional legacy EDC systems where data is transcribed post hoc from the study visit.
The Legacy EDC Transcription Model
In the current model, clinical research sites collect source data, which is the data collected contemporaneously during the patient visit with the protocol-prescribed procedures, and then transcribe this data into the electronic case report forms (eCRF) housed in an Electronic Data Collection (EDC) system provisioned by the sponsor. This transcription is not contemporaneous and can lag weeks and even months. This leads to data quality issues and rework for the sites and sponsor.
What if I am Committed with My Current EDC System?
Many life science companies and CROs have invested significant amounts of money, time, and resources in traditional legacy EDC systems. It may be difficult for companies to switch their internal processes immediately to take advantage of eSource. These companies have SOPs and work instructions based on the legacy EDC transcription model. Some larger life science companies have multi-year enterprise contracts with the major eClinical vendors that they might not be able to get out of in the short term. For this reason, switching off their EDC vendor may not be a realistic near-term option.
What is eSource to EDC Integration?
CRIO has developed a real-time eSource to EDC integration for just such situations. As data is entered and validated by CRIO’s eSource system, this same data is sent to a target EDC system. Since this data was cleaned and validated upon entry by CRIO, the data being sent to the EDC system is cleaner. There are no transcription errors since the site does not need to transcribe data into EDC. There are no point of entry errors, typical with paper source, since the validations in CRIO’s eSource system will warn site users about discrepant or inconsistent data.
This turns your legacy EDC system into an eSource system. The data in EDC is as real-time as the data in the CRIO eSource system.
How do I take advantage of this?
CRIO’s solution includes building out the eSource template for the sites to match the protocol specific data points, while allowing each site the flexibility to add site specific procedures and visits to meet individual workflow requirements.
CRIO provides the integration and validation of the connection between CRIO eSource and the EDC system. Any updates or amendments along the way are handled with change control and applied as these changes are rolled out. In fact, an amended version of CRIO’s eSource system can even be deployed prior to the corresponding eCRF, ensuring that sites adhere to the most current protocol; CRIO can simply batch transmission the data once the corresponding eCRF is deployed.
What Are the Benefits for Sponsors and Sites of this Approach?
For sponsors, this allows the existing SOPs and processes designed for the legacy EDC model, to continue to be used.
Data managers can continue to use the EDC system they are familiar with to review, clean and code the data albeit this data will be much cleaner coming into EDC than before. They can review data in real-time and continuously, allowing for faster identification and communication of data quality issues to the site. By having access to real-time data, database lock can be done quicker since data managers will know exactly how much patient data is left to clean, and they do not need to check to see if the site has transcribed all the data yet.
CRA’s can use EDC for remote source data review on an ongoing basis. They can correct issues with the site in near real-time, thus avoiding unnecessary protocol deviations, while keeping enrollment on target. They also avoid the need for the clerical task of SDV, which neither the CRA nor site enjoys.
Sites get the benefit of not having to re-enter data into the EDC. This frees up significant time at the site, allowing them to spend more time on recruiting and retaining patients.
eSource to EDC Integration
Being committed to your legacy EDC system, does not mean you have to miss out on all the benefits of eSource. CRIO’s eSource to EDC integration can provide you with many of the benefits of eSource without having to switch your EDC vendor in the near term. Process change can be difficult for many companies but that should not preclude you from garnering the benefits of new and innovative technologies. Schedule a demo to explore CRIO.
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