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Clindox CEO Mats Forsgren talks to PBR about latest trends in clinical trial management

Mats believes that technological advancement is developing new ways to make clinical trials quicker, more efficient and more cost-effective for everyone. So we asked him why.


(Pharma Business Review) Mats, as CEO of CRFweb you’re pretty well positioned to see how organisations are managing their clinical trials. What are the major trends you’re seeing.

(Mats Forsgren) Well the primary one is obviously the move from paper-based trials. For years, Clinical Trial Management Systems were pretty much the domain of the larger pharma companies, who could afford the major investments of time and money required. Now finally, with the emergence of companies like ourselves, the smaller to mid-sized companies are getting a chance to reap the benefits without the expense… after years of talk there is finally momentum gathering and these companies are making the switch .

(PBR) So CTMS systems are now cost-effective for the smaller organisation?

(MF) Absolutely. Historically, the smaller guys have stuck to paper because the alternatives were impractical or cost-prohibitive. Even today, it’s estimated that roughly 50% of regulated trials are still paper based (and even higher for non-regulated). But now there are viable alternatives.

(PBR) So why is it now viable?

(MF) It’s cost-efficiency. Taking CRFweb as an example. It’s a web-based product that requires virtually no investment in infrastructure. It has all the key features the small to mid-sized organisation needs with none of the complications. It’s flexible – adapting to an individual organisation’s needs – and they can set it up themselves or we can do it for them in hours or days not weeks or months. With these reduced set-up times and costs, the main obstacles for moving to electronic case report forms(eCRFs) are removed, and our pricing is sensible enough to make the proposition very cost-effective.

(PBR) So, basically, you’re saying that the days of paper-based clinical trials are numbered?

(MF) I think so yes. It’s about time really! The world is now online, people do business from their tablet/laptop, often remotely, every day. It makes sense that those involved in clinical trials can use this technology, that they carry with them every day, for their work. Especially when you consider that typically trials have subjects that you may have to physically visit.

(PBR)So how is technology helping those visits?

(MF) Our solution to this has two main thrusts. Firstly we’ve developed an ePRO module that’s fully integrated into the CRFweb system. This means that patients can simply login to a secure area and fill out the relevant questionnaire, saving the need for a visit. There’s a clear time saving benefit here, and also it opens the door for greater patient engagement in the trial process in itself a benefit and an industry trend.

Secondly, we’ve launched the CRFweb app. The key element here is it allows for offline data entry. The investigator can collect data from a subject offline without any concerns about data security, through public/private wifi etc.. Then later, when back in the office/secure network environment, the system can automatically connect and upload the data. There are of course some parts of the world where not everyone has an internet connection. We’re currently rolling out a multi-site project in India where this app is fundamental to the project. The trial simply couldn’t be managed as an eCRF without it.

(PBR) What other trends are you witnessing Mats?

(MF) Well I just mentioned a multi-site project in India, the sites in that study cover a variety of regions with multiple dialects, and our latest release of CRFweb has multi-language capability. I think this is a critical capability for any clinical trial management system going forward as so many trials now cover multiple sites and countries.

Another trend would be the need for speed. The world changes so rapidly, people want their trials to be managed efficiently and securely, but they also want their products to market as quickly as possible – which in turn means their trials up and running as quickly as possible. We can put a typical eCRF together in a couple of days and we back it up with a setup guarantee.

Finally, there are simply more organisations across divergent industries with a requirement to trial. We are working with pharma, medical device companies and CRO’s. Often, we’re working with new dynamic companies in a competitive world who need a rapid response. There’s also an ever-increasing variety of trials beyond the traditional phases…. for example post-approval marketing and a broad range of ongoing research requirements that CRFweb is ideal for.

(PBR)You’ve mentioned security a few times Mats, what are the security concerns?

(MF) We live in a world where big organisations get hacked, and where individuals have their identities stolen so security is a concern many have in all works of life. In our industry, the data is confidential and rightly there are strict regulations regarding this. It’s not surprising that security is something we get asked about a lot. In short, security and compliance is paramount and it’s something we take very seriously. We use the latest encryption technologies, we are FDA 21 CFR Part 11 compliant; we code to CDISC protocols and use only proven European and US based servers. There are no short-cuts here, we place security at the heart of any development.

(PBR) So Mats, what do you think will be the next ‘trend’ in Clinical trial Management?

(MF) Well naturally, I look at this from a technology perspective and the next area we expect to grow is the diagnostic wearable medical devices market. In just a few years, the consumer market for fitness trackers has grown exponentially, and it seems a logical step that collecting ‘live’ data from subjects is an area of real opportunity in the trial market. It’s an area we are currently developing for CRfweb.