ARTICLE FOCUS:

• Complexity of imaging based clinical trials
• Cloud benefits
• Applying SaaS

Clinical trial image management for medical devices has joined many other technologies in the "cloud," providing on-demand access to software applications via the Internet. This cloud computing approach, known as Software-as-a-Service (SaaS), is offered via a subscription or "pay-as-you-go" model, and is providing numerous benefits to increase the efficiency and effectiveness of clinical trials for devices.

In order to appreciate the magnitude of these benefits, it's important to understand the cost and complexity of today's clinical trials. With some medical devices costing in the $25,000 range, and because each clinical trial participant must be given the device, experts have estimated that a clinical trial for a medical device can cost a manufacturer anywhere between $500,000 and $10 million, with implantable devices such as heart defibrillators exceeding those numbers.

Therefore, device manufacturers must be able to make cost-effective go/no-go decisions as early as possible during the clinical trial process based on available data, which can be overwhelming.

Dealing with overload
Moving from paper-based to electronic processes has significantly improved the ability for trial sponsors to capture, analyze, and report data; however, the requirements to collect more data and new types of data has made the management process even more challenging.

As technology has advanced, images have become important tools in medical device clinical trials and the ability to integrate them into the overall clinical trial is critical to the success. Images of a human body before, during and after a medical device is used or implanted, can reveal how well the product works and whether it is safe for the patient.

Therefore, during the clinical trial process, sponsors collect a wide range of images, often from different sources and at multiple locations. To properly manage these images, it is important that sponsors have cost-effective clinical trial image management solutions in place. The right solution can ensure the quality and integrity of the data from receipt to final data transfer, provide flexibility to enable collaboration; and offer the scalability to grow as the organization and its clinical trial needs increase. With such solutions, medical device manufacturers can also gain back control of their clinical trials and be able to selectively outsource certain components of their trials.

Navigating bumps in the road
Current technology solutions such as enterprise archival systems, imaging core labs, electronic data capture systems, and custom-developed in-house solutions, are designed to address today's data management issues. Still, challenges remain, including:

• Potential for errors, due to the increased complexity of clinical trials. When errors occur, delays happen and costs increase. Also with QA/QC done later in the process, the potential for error increases.
• Lack of control when using external parties to manage trial data. Without timely access to data, trial sponsors are rarely able to make course corrections that may limit risk while containing costs.
• Inflexible solutions often dictate what sponsors can and cannot do.
• Expense and inefficiencies related to labor-intensive processes.
• Lack of standards to follow from trial to trial.
• Standalone solutions don’t integrate well with other systems, hindering collaboration.
• Inadequate functionality associated with reverse engineered technology solutions that are not very comprehensive.

Back to the cloud
Now that we've established where medical device clinical trials have been in terms of cost and complexity, it’s time to head for the "cloud" and discuss the potential for increasing the efficiency and effectiveness of medical device clinical trials. Here, then, are the benefits of a cloud computing approach: