What Sponsors Need to Know About Conducting Clinical Trials in Europe

Bratislava, Slovakia

Ahead of the marcus evans Evolution Summit Fall 2018, read here an interview with Alexander Fetkovsky discussing what kind of CROs sponsors need in order to stick to their clinical trial budget and timelines. 

“Sponsors can speed up drug development and reduce costs by working with one clinical research organization (CRO) that offers the full range of services they need,” according to Alexander Fetkovsky, Managing Partner, SanaClis. “A number of CROs have offices across Europe but they actually outsource many services to third party vendors. That leads to unnecessary delays and costs to the sponsor. In Europe, only SanaClis covers the full range in-house and with our new CRO in Germany, we are able to cover 80 percent of the population in Europe,” he adds.

SanaClis is a solution provider at the marcus evans Evolution Summit Fall 2018, taking place in Texas, September 24-26.

How is SanaClis expanding into Western Europe? What will the new CRO bring on board?

With the CRO in Germany we have acquired, we have coverage of 80 percent of the European population spreading from Eastern Europe up to Western Europe. Our new CRO’s specialty is project management, which allows SanaClis to increase its own capabilities in the area.

The beauty of this acquisition is the chemistry between the two companies. The two owners have worked together in the past, alongside our newly appointed CEO.

Why did SanaClis hire a new CEO? What experience does he bring in?

We are expanding the coverage of our services and launching a new feature that we wanted the existing CEO to be fully focused on. This project is the largest SanaClis will undertake for at least the next two years, and he would not have enough time for both responsibilities.

This is the reason why the SanaClis board, which includes the previous CEO, decided to hire a new CEO, Vladimir Misik. Dr Misik is not part of the owner’s family, but the board has known and trusted him for many years. He comes with over 30 years of experience in biopharmaceutical research and development, including 17 years at Quintiles (now IQVIA) in multiple roles. He also founded the clinical trial informatics company LongTaal.

What difficulties do sponsors in Western Europe usually encounter? How will SanaClis address those issues?

The difficulties vary depending on each project, but in general, trials are more expensive than in Central and Eastern Europe, for example. From a recruitment perspective it may not be that important for a sponsor to have a presence in Western Europe, but from a marketing perspective it is a must. Germany is the biggest market for the pharmaceutical industry in the EU. Compared to other CROs, we give our clients a more cost-effective way to meet targets while covering potential marketing needs. What differentiates us from others is that we have all the services they need. No other organization in Europe covers everything in-house, including clinical supply chain management, Qualified Person (QP) services, QP release from a third country such as the US, Israel and Asian countries that are not part of the EU. These are the types of services sponsors are struggling with today.

Of course a sponsor can hire a global CRO that will outsource these services, but that would definitely have a negative impact on their budget and proof-of-concept study. The more vendors a sponsor has, the more that will delay their schedule just because communications between different organizations take time. It is cheaper to have their trials directly in their own hands. 

Source: https://events.marcusevans-events.com/evolution2018-alexander-fetkovsky