Clindox UK: Precision Medicine UK recently met up with Mats Forsgren, CEO of Clindox, developers of the CRFweb clinical trial software system.  Mats believes that the days of the paper-based clinical trial are numbered, he tells us why..

PMUK: CRFweb is a new player in the clinical trial management system arena. EDC for clinical trials isn’t a new concept and there are plenty of existing systems, so why launch another?

MF: Others were not meeting everyone’s needs.  Smaller organisations have been sticking to paper because the alternatives were either impractical or cost prohibitive.  Roughly 50% of regulated trials are still paper based (even higher for non-regulated). So we set out to offer these businesses a viable alternative.

PMUK: How can this work?

MF: We’ve built a web-based product that requires practically no infrastructure investment that can do everything the existing systems can do… whilst being flexible to adapt to an individual organisation’s needs.  Up front set-up costs and lead time are the main perceived issues with eCRF’s but CRFweb overcomes these. After basic training, users can set up a study themselves in a few days and our pricing model makes it competitive for all trial sizes.

PMUK: Are you saying anyone doing a clinical trial using a paper-based system, no matter what the size can use your product?

MF: In a word, Yes. Actually, anyone spending heavily on a current CRF software system should also be talking to us.. a benefit of the business model is that the real hard work went into designing a system smart enough to do much of the work itself… a simple user interface requires a lot of back-end development. We put that effort into development and can set up a typical eCRF in less than 48 hours, where others take months. This is a massive benefit, and of course can provide a best practice approach. Initially, we guide our clients through the process, but moving forward it becomes DIY.  We have support staff and are not hindered by lengthy training programmes and vast resources going into development for individual clients.

PMUK: You quoted a figure of 50% of clinical trials still being done on paper,  do you see that changing in the next 5 years? why is it such a high %?

MF: The pace of change is always hard to predict, but it is definitely changing. In most industries where new technologies come in. If I look at our own experience, when we talk to those with experience of other systems, the benefits of CRFweb versus their current system are generally very obvious to them. When we talk to people doing paper-based trials, typically they’re equally impressed with what our system can do, but it can seem a big change for them… and they have other stakeholders to convince within their business. So this makes for a fairly lengthy lead time.  I think there’s a ‘safety in numbers’ element to it. One day soon, like the take up of mobile phones and tablets, it will be seen as archaic to not manage clinical trials in the way we do.

PMUK: You mention mobile technology, presumably CRFweb allows data to be captured live?

MF: Absolutely, there’s no duplication of effort. Data collection and management can all be done remotely on a tablet or laptop, whilst with a subject.

PMUK: Are there any particular segments of the industry that you are focusing on?

MF: we can cater for all sectors. Flexibility is one of the big strengths of our system. It really does mould to the requirements of the client, rather than needing them to change how they set up their processes.  We’ve had especially strong interest from the medical devices sector. CRFweb works just as well for them, and often they are younger businesses more receptive to change and in tune with technology.

PMUK: What advice would you give to those still conduction paper-based trials?

MF: It’s really not as a big a change as you might think. It really will save you time and money.