Hybrid paper and electronic data capture (EDC) in clinical trials
In 1960, the time taken to bring a new drug to market was three years. At the start of the new millennium, the figure had risen to 12 years. Today, it takes between 15-20 years while the cost per new drug produced is estimated to have grown at an annual rate of 13.4% since the 1950’s (Source: University of Birmingham, writing in the BMJ Open Journal, 2013).
Clinical trials are the longest and most expensive component of the drug development process with a three phase trial involving hundreds to thousands of people and costing millions. Some of the cost is linked to data collection in clinical trials and it is widely acknowledged that clinical development remains largely a paper driven process.
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.
The nature of clinical trials means that we need highly accurate data to be captured from a large user-base in a timely manner. The TeleForm solution, provided by ePC, has allowed SEWTU to expand its productivity with these objectives in mindJohn Evans, Information Manager, South East Wales Trials Unit (SEWTU)
At ePC, we specialise in electronic and paper based solutions for automated capture from paper, fax and electronic trials, patient follow-up, CRF and survey forms.
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 618,000 people involved in 2014/15 (Source: NIHR Clinical Research Network / Department of Health).
eClinical reads handwritten forms via a scanner and/or fax server to extract data, record marked diagrams, spot mistakes and validates the data before automatically exporting the results into your existing databases.
ePC are making a valuable contribution to our aim of running clinical trials in an efficient and cost effective mannerDr. Ingrid Potyka, Senior Clinical Operations Manager, UCL
- 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
How it works
- Create your clinical trial forms with TeleForm Designer
- Capture clinical trial data capture from paper, fax, PDF or eMail
- Ensure accuracy of clinical trials data and highlight issues for clarification in TeleForm Verifier
- Export clinical trials data and integrate with your preferred database, or in-house application
- Archive and retrieve trials data securely and conveniently for total accountability
The London School of Hygiene and Tropical Medicine (LSHTM) and MenAfriCar are using eClinical to study meningococcal meningitis carriage in households in Africa and document the impact of a new vaccine (PsA-TT) on reducing transmission of serogroup A meningococcal meningitis.
University of Plymouth
eClinical is used to support the scanning of clinical assessment forms for medical students at the University of Plymouth.
King's College London
King's College London is using eClinical to scan, verify and export paper case report forms from several trials, including the SentiMAG multicentre study, directly into a database.
GIG Cymru / NHS Wales
GIG Cymru / NHS Wales is using eClinical to scan, verify and export paper case report forms from the 'All Wales Medication Safety Monitoring' trial into a database.
Keele Clinical Trials Unit
Keele Clinical Trials Unit (CTU) specialises in the development and delivery of high-quality multicentre clinical trials, testing treatments and health services, as well as other high-quality clinical studies, including large epidemiological studies, in primary and secondary care settings with the aim of improving patient care.
Keele CTU has a well established track record of research delivery particularly in the areas of primary care research. Operational services such as trial management, software development, data management and statistical services are provided to support the delivery of high quality, ethically and clinically relevant research. Staff within the CTU have a strong knowledge base of research methodology and Trust/Primary Care procedures. They have an understanding of the needs of the Sponsor, Investigator and the Participants.
To facilitate the required data collection for their studies, Keele CTU uses TeleForm software to scan, verify and export paper questionnaires and case report forms directly into a database.
Website: Keele CTU website
Schedule your demo
If you want to learn more about hybrid paper and electronic data capture in clinical trials, or wish to book a demonstration, please complete the form below: