Paper and electronic data capture for clinical trials and biotech organisations

Capturing high volumes of patient data from case report forms, patient surveys or questionnaires is a time-consuming and labour-intensive task.

eClinical is a data capture system that combines traditional paper-based surveys with electronic data capture to enable you to process patient data with clinical efficiency, without compromising accuracy, reliability or audibility.

Used as part of an FDA 21 CFR part 11 compliant system, eClinical is a viable, high-quality and lower cost alternative to the large and complex EDC systems used in clinical trials.

Challenges

Clinical trials are the longest and most expensive component of the drug development process. A three phase trial can involve hundreds of people and cost huge amounts and some of this cost is linked to data collection.

With trial managers under pressure to effectively manage costs to ensure their budgets and timelines are controlled, this is one area where efficiencies can be created.

Solution

At ePC, we enable clinical trials organisations - including a number registered with the UK Clinical Research Collaboration (UKCRC) - to process high volumes of paper and online forms more effectively at a time when the number of participants taking part in clinical research in England is increasing with more than 870,000 people involved in 2019/20.

Paper-based clinical trials

For paper-based surveys, eClinical reads handwritten forms via a high-volume document scanner and/or fax server to extract data, record marked diagrams, spot mistakes and validate data before automatically exporting the results into your existing databases.

How it works

• Create forms (e.g. CRFs, PROs, patient follow-up and questionnaires) with re-usable fields, sections and design elements
• Capture clinical data from multiple sources (MFPs, scanners, fax, eMail, web and smartphones) in both centralised and distributed capture environments.
• Index and extract clinical data from scanned documents using OCR, ICR, OMR, and barcode technologies. Only invalid or unrecognisable fields are shown to human operators.
• Export clinical trials data and integrate with your preferred database, or in-house application
• Archive and retrieve clinical trials data securely and conveniently for total accountability

Key benefits

• Accelerate all phases of the drug discovery process
• Reduce costs of drug discovery and clinical trials
• Enforce a completely 21 CFR Part 11, Medicines Act (1968), GCP and GMP compliant process
• Reduce CAPA processing time by over 80%
• Minimise staff costs and time spent processing forms
• Eliminate mistakes, improve accuracy and reduce time spent retrieving paper copies

Example paper case report forms (CRFs)

You can visit our eClinical microsite for further information.

Electronic data capture

Whether you're an investigator, monitor or sponsor, eClinical supports you to meet GCP requirements with online forms, dashboards, audit trials, archiving and more.