Hybrid paper and electronic data collection in clinical trials

A robust trial design is essential to secure the allocation of funds and comply with regulations. Part of this work involves planning how to handle data collection in clinical trials. Accurate data capture is essential for compliance with Good Clinical Practice (CPMP/ICH/GCP/135/95).

Used as part of an FDA 21 CFR part 11 compliant system, eClinical is a data capture system aimed at clinical trials, contract research organisations (CRO), and biotechnology organisations that need to capture data from paper and/or electronic forms.

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Clients

Data collection in clinical trials

Traditionally, data collection in clinical trials was a largely paper-based process. Typically, data would be collected in a paper CRF and manually transcribed into a database. Double data entry and data monitoring methods were commonplace to ensure data integrity.

Many still use paper forms but want a more efficient method of extracting data from the documents.

Additionally, electronic data capture (EDC) systems have become popular in recent years as the scale, complexity, and cost of clinical trials increased while technology presented new opportunities for efficiency gains. EDC systems replace paper forms with computerised forms to improve data completeness, consistency, and unambiguity, e.g., automatic edit checks and validation checks.

eClinical is a viable, high-quality, and lower-cost alternative to the large clinical trial management systems (CTMS). Please click on the links below to learn more.

Paper-based clinical trials

Scan paper case report form (pCRF), extract verified data with OMR/OCR/ICR technology, and export data to common file formats or databases with data capture software.

Electronic data capture

The EDC module in eClinical simplifies regulatory compliance with online forms, web interfaces, audit trails, access control, version tracking, electronic signatures and more.

York Teaching Hospital save 165 hours by moving from paper to electronic data capture

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

Testimonials

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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

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Teleform/ePC have been the lynchpin of data collection in our home diagnostic clinical trials for many years. As a small team, the software has given us cost-effective and flexible control to manage a diverse range of paper-based trials using a fully-featured form designer with support for downstream verification workflows all the way to export, while ePC have been instrumental in managing and maintaining the service availability with a high standard of professionalism and technical capability

SPD Swiss Precision Diagnostics GmbH

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The data capture is much faster and more accurate. More often than not, forms go through without the need to review them. Any issues are usually related to the design of the form or participants not understanding the question or answering it in a way that was not intended. Many users have said the verification process is not only more accurate, it is less of a chore; they actually enjoy verifying now

Jo Smith, Database Interface Manager, Keele CTU

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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

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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

Case studies

TeleForm

4.5 / 5 | 2 reviews

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Hybrid paper and electronic data collection in clinical trials

Clients

Data collection in clinical trials

Paper-based clinical trials

Electronic data capture

York Teaching Hospital save 165 hours by moving from paper to electronic data capture

Testimonials

Case studies

Keele University

York Teaching Hospital

London School of Hygiene and Tropical Medicine

Verified product reviews