e-clinical trials are not a new idea. Today, IT and biotechnology companies are continuously working to improve user operability and efficiency through sophisticated web tools and data-capture systems.
The evolving nature of web-based technology means industry executives and decision-makers must stay abreast of the latest developments to help improve data management, storage methods and efficiency.
Ahead of Arena International's e-clinical trials conference in Germany in May 2010, pharmaceutical-technology com speaks exclusively to senior director for product strategy at Perceptive Informatics Bill Byrom to find out exactly how the company is working to improve e-clinical software by using data integration methods.
Drugdevelopment-technology: How would you define e-clinical technology and how does it work?
Bill Byrom: Everyone has a different interpretation of e-clinical. A lot of people simply mean an electronic solution. We, and a lot of people in the industry, are saying it's a little bit more than that.
What e-clinical really means is how you can combine technologies together in an integrated way and how you can get them to work together as one solution. The industry has been working towards this for some time.
DDT: Can you explain how these systems work?
BB: We routinely send data from RTSM (real-time system manager) systems to electronic data capture (EDC) systems and others and we receive data back from them.
Each system has its own function and shares common data. From a data quality and workload perspective, there is great advantage in that integration. Data integration between different systems is really quite important and there is almost an expectation when these solutions are purchased that there will be ability for some sort of data integration.
DDT: Why is it important to come up with a single system solution?
BB: Integration is valuable. Without it, we are not necessarily meeting the needs of the end user.
We looked at a site in Belgium recently where those conducting the trials were looking at 17 different pieces of technologies across 17 clinical trials. As such, each person had to learn and operate numerous systems. In terms of workload alone this is time consuming, especially as these were people doing clinical trials in their spare time.
So we try to do anything we can to save time to make workflow easier. This is where convergence comes in.
DDT: What is convergence?
BB: Convergence is making functionality for one solution accessible to another. There are bits of shared functionality. It is, for example, like using Microsoft IT systems – you don't have to learn anything new, the same method of usage is involved across the board.
For example, the iPhone is a single interface in which there are lots of different applications. From an end user perspective, this makes this kind of system very easy to use.
We have been looking at the relationship between EDC and RTSM. EDC is a data capture system into which we've integrated things like randomisation and dispensing. A lot of our current focus is thinking about how we can move from data integration to making workflow easier.
DDT: What happens if one part of the systems malfunctions or goes offline? Does the whole system go down?
BB: You need to build in additional flexibility because if such a situation happens, for example, the whole system goes down, you still have to be able to use the systems.
What we don't want to do is create one system – behind the scenes you will still have individual systems operating. The user can choose the way that is more convenient to them to use. If you look at IDR telephone-based systems there are always different ways you can get into the system. This enables the user to access what they want.
DDT: When will the convergence systems be available for use in trials?
We are still researching our convergence systems. We are actively looking at how to bring data together, so those performing trials can see, in a single place, how their trial is performing.
DDT: Oncology is one of the biggest growth areas in e-clinical trials. Are you doing any special work in this area?
BB: You can argue that independent of the therapy area, the requirements of the products are pretty similar. Oncology studies actually are interesting because there can be different ideas about dosage, patients and type of treatments more peculiar to the type of therapy area. However, most of the applications apply to any therapy area.
Some of the other areas like medical imaging, bone density etc are good examples of pulling info from different areas. You can play with the applications to some extent to tailor them to the needs of the trial.
DDT: How costly is it to produce this software for e-clinical trials?
The systems are, financially, not expensive. Our strategy is to make them appealing to our clients.
Arena International's e-clinical trials conference takes place on 18 and 19 May 2010 in Munich, Germany.