Contract Research & Services
Clinical Trials

Is it the End of the Road for Paper-Based Clinical Trials?

Published 05 May 2016 | By Clindox

PBR 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, so we asked him to explain why.

PBR

Mats, CRFweb is the 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?

Mats

Because the others weren't meeting everyone's needs. The big players in the pharma industry can throw money at a system with all the whistles and bells they require, while the smaller guys have been sticking to paper because the alternatives were either impractical or cost prohibitive. It seemed crazy to me that in this day and age, roughly 50% of regulated trials are still paper based (even higher for non-regulated). So we set out to offer those businesses a viable alternative.

PBR

And have you?

Mats

Absolutely. We've built, from scratch, 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 a no-brainer cost-wise for all trial sizes.

PBR

So, basically, you're saying anyone doing a clinical trial using a paper-based system, no matter what the size, should be talking to you?

Mats

In a word, Yes. Actually, anyone spending heavily on a current CRF software system should also be talking to us!

PBR

So are they talking to you?

Mats

Some are yes, we're taking on new clients all the time and although we're busy, we can always accommodate new business. A benefit of the business model is that the real hard work went into designing a system smart enough to do much of the legwork itself... a simple user interface requires a lot of back-end development. Because we put that effort into development, we can set up a typical eCRF in less than 48 hours, where others take months.

Clindox

Initially, we guide our clients through the process, but moving forward it becomes DIY. So, we have the support staff we need, but we're not hindered by lengthy training programmes and vast resources going into development for individual clients. That's why we can be so price competitive, and we can spend our development budget on an ongoing programme of continuous improvement.

PBR

You quoted a figure of 50% of clinical trials still being done on paper, how do you see that changing in the next 5 years?

Mats

Well the pace of change is always hard to predict, but it is definitely changing. In most industries where new technologies come in, initial take up is slow, but at some point the momentum builds and there's a tipping point. 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.

PBR

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

Mats

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.

Clindox

PBR

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

Mats

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. Consequently, we can cater for all sectors. 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.

PBR

If you are right about where the market is moving to, surely there are lots of competitors, existing and new, chasing the same targets. How are you different?

Mats

Well there are numerous companies, making a variety of claims about their systems and I don't pretend to know all their products in detail. But we listen to our prospects and clients who have experience of some of them and the feedback is that no-one offers as much as we do, as well as we do it... in terms of system capability, flexibility and set-up time... for anywhere near the price we offer.

PBR

You sound very confident about your system's capabilities Mats, what would you say to those out there still doing paper-based trials?

Mats

Yes, I believe in my business! I'd say this to anyone managing paper-based trials. It's really not as a big a change as you might think. It really will save you time and money. But don't take my word for it, see for yourself. We offer a free trial. You could be trialling one of your own CRF's on our system in just a few days. What do you have to lose?

 

Mats Forsgren is CEO of Clindox

Clindox
Clindox was founded by Scandinavian, British and Irish entrepreneurs to develop groundbreaking clinical trial software. They have offices in Ireland, the UK and India.

Call: +353 1 4800 540 (Eire) or +44 1732 808 976 (UK)
Email: info@clindox.com
www.clindox.ie