An increasing number of published clinical trials use electronic data capture software for clinical data capture. Yet despite the rapid adoption, many EDC systems are overly complex and require significant skill and resources to implement.
eClinical is a user-friendly electronic data capture system that simplifies compliance with ICH GCP E6 R2 standards and other regulations such as 21CFR Part 11.
We provide an end-to-end service; from pre-project advice and product demonstrations to an ongoing partnership once implementation is complete.
We are happy to discuss your requirements before submitting a grant application or complete a Request for Information (RFI).
Our team can offer advice if you are building your user requirements specification (URS) as well as provide externally accessible prototypes for review/feedback during the build phase.
Before deployment, we can support your user acceptance testing (UAT) and arrange penetration testing.
Once the system is released into production, we will support you with comprehensive documentation, training, and technical support.
An eCRF enables data on each trial subject to be captured, reviewed, managed, stored, analysed, and reported to the sponsor.
eClinical includes a graphical drag-and-drag interface to design electronic case report forms (eCRFs) as per the study protocol.
All forms have real-time data validation (edit checks) to highlight inconsistent, invalid, or missing data as well as skip logic and conditional rules for data input. These logical field validations ensure no inaccurate data is submitted and reduce the number of queries directed to sites later.
Once submitted, the forms will be locked down with users no longer able to edit or modify the form unless a controlled and auditable amendment process is required.
The forms are rendered with standards-compliant HTML/CSS (allowing WCAG 2.1 AA standards to be met) and the platform can collect and store data in a GDPR-compliant way.
From query management to overall study approval, the platform allows users to perform several actions depending on their permissions/roles. An example set-up is outlined below:
From trial protocol and informed content to eCRF and PI approval, the document management capabilities in eClinical provide an access-controlled central repository for the management of essential documents for all stakeholders involved in the clinical trial (sponsors, CROs, and sites).
The electronic data capture system provides tools to manage, route, access, monitor, and archive essential documents and maintain accurate trial records and data to fulfil ALCOA (++) requirements.
All documentation is securely stored and access-controlled with versioning and automated disposition supported.
The platform offers sponsors, investigators, and other parties insight into the study’s progress.
The interfaces provide remote oversight of source documents and site activity as well as real-time reporting on any number of parameters such as patient recruitment (overall or by hospital site) and forms awaiting correction. You can also generate custom reports for distribution.
The electronic data capture software allows system administrators to grant, change and remove individual access rights in a timely manner e.g., when staff leave or delegated duties end.
The platform removes the requirement for a wet-ink signature, providing user authentication to record every action taken by participants. The system also supports electronic signature authentication, and timestamps when an activity is performed.
From the original CRF creation, eClinical provides a secure audit trail with all subsequent modifications of electronic data by authenticated users recorded and timestamped.
All electronic data is archived for future retrieval - with retention and disposal limits automatically applied.
This removes the need for costly paper storage and time-consuming retrieval.
eClinical provides one-click export of clinical data for internal reporting, statistical analysis, and long-term storage/preservation.
Additionally, the PI can confirm the case report forms for all subjects are complete and accurate and sign off data at the end of the study.
You can also generate custom reports for distribution.
Alert users when tasks are assigned to them and notify, escalate and reassign the task if timely action is not taken.
With eForms, the accuracy and timeliness of data collection has improved immeasurably. This was not possible with paper and means we can begin analysis much quicker to establish if the FIT can accurately detect colorectal cancer in patients.
Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
eClinical can be implemented in a few weeks once the trial protocol is approved.
Clinical trial organisations can significantly reduce the time to build, validate and release a study with the EDC system supporting faster patient recruitment, greater savings, and quicker activation of sites.
Manual data entry is a laborious and tedious task.
Completing case report forms online will significantly reduce manual data entry and make CTUs, CROs and investigator sites more productive. It will also eliminate the risk of transcription errors and improve data accuracy.
To maintain confidentiality, it is possible to anonymise data so that you cannot identify a subject (patient) by any personal details (e.g., by name, address and DOB), with a unique patient number used to link their data instead.
The platform automatically highlights out-of-range, implausible, incorrect, or missing data for site investigators to resolve at the time of data entry/submission to ensure the validity and quality of clinical information.
eClinical is a modular platform supporting both paper-based clinical trials and electronic data capture.
It is even possible to mix and match between paper and electronic forms, as and when appropriate.
All trials must maintain a system that prevents unauthorised access to data.
The EDC system includes security controls to ensure data confidentiality, integrity, and availability. These controls include HTTPS (SSL\TLS) encryption, user access rights, unidentifiable patients, data encryption while at rest, and audit trails.
The ICH GCP E6(R2) addendum highlighted a risk-based approach to monitoring in clinical trials to improve efficiency. Clinical trial organisations can specify in the monitoring SOP whether on-site monitoring, remote monitoring, or both will be used during the study.
The platform facilitates remote source data verification (rSDV) with clinicians and site monitors able to find queries faster and resolve issues directly in the web interface – and make operational savings compared to on-site monitoring.
eClinical is deployed either on-premise or in the cloud in a UK-based ISO 27001 accredited data centre with a 99.9% uptime guarantee. The data centre has 24x7 manned security and full building CCTV coverage.
If you prefer, we can host your electronic data collection software within the Microsoft Azure global infrastructure, allowing you to keep your business-critical data in any region and comply with relevant legislation.
Electronic data can be backed up in a geographically dispersed way much easier than physical paper.
For cloud-hosted systems, all data on a server at the primary data centre is periodically replicated to a secondary failover site in a separate physical location.
The implementation has been a smooth process. ePC have been really helpful throughout the project. They were able to offer advice when designing / planning the eCRF and help us iron out challenges before they became major issues. Their advice has really helped us focus on what data we needed to collect in order to meet trial objectives and regulatory requirements. I highly recommend them to other CTU’s seeking to implement an eForms system
Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
Overall, we have been delighted to have the ongoing support, close cooperation, and ability to react to our requirements that ePC have provided. Their ability to make changes to the functionality of the system has led us to realise the value of the EDC system in this study. It is already supporting a further study of ours, and we will continue to work with ePC in our future studies
Chief Medical Officer, Medical Technology Company
I was hugely impressed with the personal contact from ePC. With the big pharma companies, you never speak to the same person twice, and might not get a response for weeks, so being able to contact ePC directly and know they’ll respond to any question or request promptly is something we’ve found extremely positive, hence coming back for a second, new trial
Clinical Study Manager, Medical Technology Company
