Data Management During Clinical Trials - White Paper

Challenge - Data Aquisition And Monitoring

One of the biggest challenges to completing a medical trial, whether for a drug or medical device, is capturing data on case report forms (CRFs) during the patient interview with the clinician and then getting the data to the research organization. Depending on the size of the trial and the number of sites, the collection process can take weeks to months, and the cost to manage CRFs in a late phase clinical trial can range from $150K to several million dollars.

These delays cost drug and device development companies time to market, first mover advantages, and create additional costs. Any inaccuracies in the data can further delays, cause trouble with FDA approval, or even impose health risks.

Many Electronic Data Capture (EDC) solutions have entered the market to solve this problem, but despite strong benefits in data transfer, adoption has been slow due to challenges in data capture. Changing process or behavior is nearly impossible, and entering data into electronic forms on PDAs, tablet PCs, or laptops requires training and a change in process between the clinician and the patient. Further, many clinicians see the device as a barrier between them and the patient. Clinicians will often use a pen and paper to capture the data and have an assistant enter the data into the EDC creating another step and another chance for errors.

For these reasons, the majority of research sites still use a traditional pen and paper to assess patients during a trial. These forms, often done in triplicate, then need to be mailed, faxed or scanned to a data processing location to be rekeyed into a database. The rekey process adds time and is often done twice to ensure accurate entry. Once rekeyed and checked for errors, it is finally sent to the sponsoring organization.

Solution - The Digital Pen

Velosum has created a solution that offers the intuitive and easy data capture from the pen and paper while getting the benefits of digital transfer, monitoring and analysis. Velosum’s system, vTrialsPlus uses Anoto digital pen and paper technology to capture handwritten CRFs and immediately transfer the data to the research organizations for monitoring and analysis.

Convincing site clinicians to use the digital pen is not difficult. With two minutes of instruction the clinician is writing normally on a CRF specially coded for each patient. As opposed to laptops, tablet PCs or PDA’s, there is no change in process for the clinician and there is no device to get in the way of the face-to-face communication. Further, research studies have shown the digital pen and paper to be faster and more accurate than PDAs, tablet PCs, or laptop computers.

The data captured from vTrialsPlus is immediately available on an encrypted web portal for authorized personnel to view. vTrialsPlus creates three forms of the data: the original CRF with the handwritten data is stored to meet FDA requirements, a PDF with the digital rendering of the CRF is available for monitoring and validation, and the data is transferred to an XML format for immediate data processing and analysis.

Velosum has designed the system to be very easy to implement in any site and is fully scalable to hundreds of sites and thousands of patents. Alerts can also be programmed to inform sites of uncompleted reports or reports that have a specific time frame to avoid protocol deviations.

The intuitive data capture and immediate data transfer of vTrialsPlus allows organizations to close trials sooner with more accurate information while lowering costs and providing greater control. For more information or a demo on the product, please contact a Velosum sales representative.
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