Alfonso García Cañamaque, CEO of León Research, gives an overview of the Spanish clinical research ecosystem and the challenges facing CROs. Also, he explains the differentiating factor of the company and internationalization strategy moving forward as they position themselves as the partner of choice.


Could you start by introducing the story of Leon Research?

The company was founded by my sister Rocío in 2007. She used to work for a US company in Madrid but her personal life led her to León, where she decided to create the company. Although I didn’t join the company officially until 2009, I was part of it since the beginning, and while she managed the company’s operations, I stayed on the business side. At the beginning, we were only three, and now there are 33 people working in the company.

We started working with foreign clients only, mostly US or British companies and foreign CROs. The main reason we worked with foreign companies was that in Spain, local companies preferred working with CROs established in big cities such as Madrid or Barcelona, while for foreign companies it did not matter. In Spain there are few companies that make decisions here about global clinical research, so most of the companies were based in countries like Germany, the US or the UK.

In 2014 we opened new offices in Portugal, and in 2016, in Italy. Our plan is to continue expanding our business and for companies to think of us as service providers in Southern Europe. At that time, we also joined an international association of small CROs called AICROS, which allowed us to offer a global service to our clients.

Initially, we only offered monitoring, regulation and CTA services. Currently, we have a broader portfolio and we also provide data management, medical writing, pharmacovigilance and consultancy services in terms of registrations and obtaining marketing authorisations.


Which are the activities in your portfolio generating the most profit at the moment?

The main activities in the company are still monitoring and CTA submissions, which account for 60 percent of our business. In fact, we are satisfied this is the case and we wouldn’t want it to change. There are around 10 people out of 33 work on support, including the ones in the Madrid offices, while the others are operational staff.


What was the rationale behind going to Italy and Portugal and how are you looking to extend further?

The main reasons we went to Portugal were a combination of proximity and clients’ requests. Many global and foreign companies still think of Spain as the Iberian Peninsula, so it made sense to include Portugal in our business. The case of Italy was different because, as I mentioned before, León Research is a family business. A family member was living in Italy; therefore, we opened new offices there. Surprisingly, in less than three years, Italy has become 35 percent of our revenues and it has proved to be a wonderful place for clinical trials and recruitment.

We are, indeed, still planning on expanding elsewhere but our growth strategy consists of consolidating growth first. We don’t want to stretch our resources too far too quickly. Nevertheless, we are already considering where to go next. Two weeks before the Brexit was announced, we had everything ready to go to the UK but now we have to look at other options. Maybe we will go to Germany, Canada, the US, and even France is a very interesting market and it is close to Spain, but in any case, we will probably wait and see what happens with Brexit first.


How are the positive changes in the Spanish clinical trial ecosystem affecting CROs?

It is true that the Spanish market is growing, now there are global companies coming and merging here, which creates a quite challenging situation. However, we are part of a CRO association, and we see this growth as a good thing. The “cake” is growing but along with it, our piece of it grows as well, there is no reason to take over somebody else’s.

Right now, we are trying to improve our marketing activities, but we are still a more reactive than active company. We have been growing at a slow pace and building our agenda of contacts in the bio-sector, which is also an advantage because even though Spain has always been perceived as an exotic and appealing place, the latest changes introduced by the Royal Decree of 2015 and the growth of the economy have been very beneficial for us.


Where do you see the main challenges coming from?

I think the main challenge comes from within Spain. I am not especially concerned about the competition; most small and mid-size CROs at the local level are very cooperative. However, I see a problem in the actions taken by many local biotechnological companies when they receive foreign funds from the UK or Germany. Instead of retaining the investment in Spain, they carry out their clinical trials and studies abroad

One of our challenges is changing our mentality. People don’t acknowledge how good the Spanish market is, the great changes introduced by the new regulations, our capacity and the results we are getting.


What differentiates León Research from your competitors?

Our flexibility. Although the services we provide might be the same as other CROs, we try to offer a different way of finding solutions and solving problems. Our small size allows us to be flexible and reliable, and we always go for creativity in our operations and marketing strategy. I believe that small changes can make a huge difference when it comes to getting good results.


How does your offer match the evolution of the demand now that companies are asking for flexibility in business?

I consider that the procedures are a framework for our activities rather than a limit – we have to go along with them, but we can also adapt to them. We have the potential to change our operations without going through a long process of communications and decision-making, which is a great advantage and gives us flexibility. It also allows us to bend our procedures if they don’t match exactly the client needs; we are not constrained to the system.


How advantageous or disadvantageous is it to be based in León?

Being based in León is wonderful. I think that León within Spain could be compared to Spain within Europe; everyone seems to likes us. That is the biggest advantage, it doesn’t constitute a problem for anybody. Furthermore, not only we are the sole clinical CRO in León, but the entire autonomous community of Castilla & León. Our position in the Technological Park is also an advantage.

The only issue we face is the difficulty in transportations when we have to work with companies in the South of Spain or in Catalonia, which becomes more expensive. Luckily, the biotech industry in Galicia and in Asturias is growing, and we have the perfect location to benefit from that growth.


How are your relationships with clinicians and private hospitals?

We have a database of more than 2000 researchers, and we have a great relationship with them. Usually, the majority of CROs are quite strict on clinicians, though I believe that we are there to give support, work and collaborate with them. They are our partners. We try to build good relations with them. After all, we are service providers and we want this service to be the best quality.


Which are your objectives for the company in 5 years?

Establishing and consolidating the offices we have right now is a very important aspect of our short-term future. After that, we will have to decide when to expand and where do it, whether it is France, Germany, the US or even the UK. We will also develop our marketing department and I expect the company to grow a 30-50 percent in size and revenues.