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As with many industries across the globe the pharmaceutical industry is growing, changing and facing challenges associated with the increased implementation of IT and technology. SanaClis is a contract research organisation (CRO) offering a comprehensive range of drug services across Central and Eastern Europe including clinical trials and laboratory testing. BWM caught up with SanaClis Sr. partner, Natalia Fetkovska, to find out a bit more about this rapidly expanding business.

Tell us about SanaClis – please briefly outline the business

The growth of big and medium sized pharma in Central and Eastern Europe as a setting for clinical trials has rapidly developed over the last decade, increasing during the latter part of the last century and into the 21st. SanaClis was an early adopter, recognising this growth area, being able to catch the momentum, identify the most critical needs of the industry and develop service areas which were not existing at the time. The introduction of these services led to the creation of local warehouses specialising in Investigational Medicinal Products (IMP) and Clinical Trials Services (CTS) management. Today, after 16 years in business, SanaClis provides the whole range of Contract Research Organisation (CRO) services for clinical trials across Central and Eastern Europe and offers a full range of clinical monitoring, project management, regulatory services, data management, pharmacovigilance, medical writing, statistics, IMP & CTS management, and IT solutions.

Tell us a bit more about the clinical trials and pharmaceuticals industry as a whole. Where do you see it heading over the next ten years?

At the clinical trial management level – similar to other business areas – IT and new technology are the areas which are likely to determine the future direction and development of the environment, and can be expected to change, grow and ultimately bring about the most dramatic developments. In terms of the challenges this will bring SanaClis envisages these changes may predict a potential future conflict of strategies involving new robust IT systems or tools versus human administrative inefficiencies and errors. Small biotech companies and big/ medium sized pharma, together with their vendors, will still face the same problems as they do today: growing costs, recruitment timelines, and trial quality.  However, during the next decade it seems probable that the biggest new challenges faced will relate specifically to IT security.

Looking at SanaClis it’s also clear that research is a big part of the company’s activity. Can you tell us a bit more about this?

SanaClis invests heavily in its own IT research and development with the aim of providing user-friendly, customised IT solutions both for the internal needs of SanaClis and also for our clients. It is an added value offered free of charge to our clients, which pays dividends in terms of retaining our clients as well as maintaining satisfaction levels. It shows that we value them and ensures they feel that we continue to invest in our service towards them.

How is SanaClis different from other clinical trials firms which offer the same type of services?

There are many CROs which offer a full range of services – from medical writing over data management and regulatory services, to clinical monitoring, pharmaco-vigilance and statistical analysis. There are, however, almost no CROs which also manage IMP / CTS, either centrally or locally. This service is most often outsourced to a specialist third party rather than handled in house, and is where SanaClis really stands out. SanaClis offers full IMP management and related services along with classical CRO services. We developed our own software for IMP management which enables our clients to have direct access to IMP stocks and movements in our warehouses, so they have full access to IMP storage conditions and transparency on storage and maintenance of stock. This is a unique service which is not provided by any of our competitors.

What are the biggest challenges facing your industry today?

As with many other industries, it’s a dichotomy of needs versus resources. Our biggest challenge is a clear paradox of trends, which is the growing need for trial complexity and quality demands on one hand, against the pressure of costs reductions on the other.

Tell us a bit more about the other services you offer. Do you cover a global market or focus on specific geographical locations?

SanaClis has its core business in Central and Eastern Europe. We do, however, work across and outside Europe via our partners within the established exQuisite Alliance.®

Tell us a bit more about your client base if you can. Who are they?

We are proud to have clients from the top ten big pharma companies in addition to small and almost unknown biotech companies from Europe, US, Asia, Israel, Japan. Our systems, our staff and our services are reliable and at the same time flexible enough to accommodate different requirements, size and even cultures. We’re proud to say that we can offer an excellent service to a wide variety of different clients based across multiple global locations.

How do you drive the development of the business?

The best driver is the industry itself – critical analysis of business needs, customer expectations, and industry trends are always vital in order to clearly chart the growth opportunities. Political developments also play a role – opening a warehouse in Slovakia enables us to manage IMP sent into the EU from/by non-EU manufacturers for example. We are always looking for new ways to develop and improve the business.

What is the single biggest advantage to companies using SanaClis?

We can help open the door to the EU for non-EU companies. At the same time we can open the door to post-Soviet countries (Russia, Ukraine, Belarus, Georgia etc.). We can do this with fewer vendors and a leaner, efficient business structure.

How do you see the future of SanaClis developing, alongside market trends?

SanaClis has a strong network of partner companies within exQuisite Alliance® across service/therapeutic areas and across countries and continents. Large or global CROs quite often place studies in countries they need to develop, or simply choose to avoid staff redundancies. This aspect – often a business imperative of a CRO – is even more often neglected by the clients although the negative impact on study timelines and costs may be quite severe.

SanaClis, however, focuses on designing optimal project-specific country splits and teams. Our aim is to offer the best possible “cost – quality” solution by using our own resources, facilities and partnership synergies. As a privately own company SanaClis has no obligation to grow its business beyond a potentially non-manageable rate or size, thereby diluting the quality of our service. SanaClis is, and would like to remain, a reliable, professional and ‘easy-to-work-with’ CRO.