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High quality 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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    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 trials

    eClinical is a data capture system that automatically performs handwritten and character recognition on paper case report forms with minimal human intervention.

    The system reads CRFs via a high-speed scanner and extracts data, records marked diagrams, spots mistakes, and validates data before automatically exporting the results to any required format.

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    Hybrid paper/electronic trials

    With the optional eForm module, eClinical can be used as a hybrid paper and EDC system.

    The system allows paper surveys to be exported from the CRF Designer as dynamic PDF or HTML forms for end-users to complete on-screen and submit to the verification module.

    Electronic data capture (EDC)

    Moving away from paper-based systems?

    ePC’s stand-alone EDC system simplifies compliance with ICH GCP E6 R2 standards and other regulations such as 21CFR Part 11.

    The platform offers online forms, web interfaces, audit trails, access control, version tracking, electronic signatures and more.

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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
    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
    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
    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
    ePC are making a valuable contribution to our aim of running trials in an efficient and cost effective manner.
    Dr. Ingrid Potyka, Senior Clinical Operations Manager, UCL
      york-teaching-hospital-case-study

      165 hours saved by replacing paper with electronic forms

      York Teaching Hospital saved 165 hours during a Phase III clinical study by replacing paper-based case report forms with electronic case report forms (eCRFs).

      Read their story

      Case studies

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      Automating clinical trial data capture

      Keele CTU saves time by capturing data from paper-based clinical trials with TeleForm.

      Keele Clinical Trials Unit uses TeleForm to capture data from paper-based clinical trials, reducing manual data entry and accelerating the availability of research data.

      Read their story
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      Capturing research data from paper questionnaires

      The University of Bristol’s ‘Children of the 90s’ study uses TeleForm to capture data from paper-based questionnaires, helping researchers convert large volumes of handwritten and marked responses into usable digital data.

      Read their story
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      Direct capture of clinical trial data

      NHS Wales uses TeleForm to scan, verify and export paper case report forms from the All Wales Medication Safety Monitoring trial directly into a database, reducing manual data entry and streamlining clinical data capture.

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      eClinical is a powerful clinical data management system for hybrid paper and electronic data capture in clinical trials.

      Alternatively, our stand-alone EDC platform includes online forms, web interfaces, audit trails, access control, version tracking, and electronic signatures to simplify compliance with ICH GCP E6 R2 standards and other regulations such as 21CFR Part 11.

      Call 03300 100 000 or complete our form to discuss your requirements.

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