A pioneer end-to-end CRO founded in Central and Eastern Europe, SanaClis has since expanded into over 20 countries worldwide. Despite this impressive growth, the company never sacrifices its high-caliber quality, on-time delivery, and personal approach to fulfilling client needs. With new offices in Croatia and the United States on their way to being operational, as well as a 21st anniversary underway, SanaClis is on track to maintain its premier status over the next two decades and beyond. Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., spoke with Alexander Fetkovsky, Chief Executive Officer of SanaClis, about their integrated service offering, why now is an opportune time to start a clinical trial, how fast track approvals can disrupt the market, and the push for regulatory harmonization.
DAVID ALVARO (DA): Can you give me a primer on the history of SanaClis and how the company has evolved to where it is today?
Alexander Fetkovsky (AF): We were the very first company to operate in clinical supply in Russia in the 1990s. This was a joint venture and not SanaClis as it is today, due to compliance with the local laws relating to foreign businesses. This endeavor was so successful that we launched another business in Ukraine and then expanded the clinical supply business again in Russia, and also built a CRO — headed by my mother, who had a decade of leadership in the space — and, finally, SanaClis was born.
The company matured and has continued to expand steadily — we’re not only in Slovakia, Ukraine, and Russia, but we’re present in more than 20 countries around the world. Our goal for the remainder of the year is to open locations in two new countries. In fact, I just signed off to solidify a new entity in Croatia — the facility will be devoted to operations and also serve as a corporate training center. SanaClis expanded into the United States in early 2020, but this was postponed due to COVID; our goal is to make this location operational as soon as possible.
DA: Has the experience of starting in Russia and Ukraine given SanaClis a different perspective or level of expertise than a similar company might have if it was founded in the United States or Western Europe?
AF: We’ve learned to be patient and to devote time and resources to understanding the local needs and nuances. Our experience has taught us that every single country is totally unique, so everything has to be handled step-by-step.
DA: How do you see the positioning and perception of SanaClis within the CRO market?
AF: I personally think that SanaClis is well known in the industry. While we’re not at the same level as a top 10 global company, we regularly receive positive feedback from our clients with respect to our quality and deliverables. This is a great basis for our continued expansion — either with our current client relationships or in new countries. Another advantage that we provide is our ability to fill many different roles, whether as a functional service provider or for end-to-end outsourcing; we have standard CRO offerings and a supply chain and sourcing options in-house, including reference products, comparators, background therapies, rescue medication, and ancillaries.
We have a very experienced team, which makes us a great fit for all types of customers. As far as our clients are concerned, they are relieved to work with one partner for all their service needs. When we work with these clients from start to finish, our track record is unbeatable — we are able to finish ahead of schedule in 93.6% of studies. This speed is key for moving products to market and achieving a return on investment.
Every single client deserves our full attention and the highest level of quality, no matter their size. While we’re not the biggest provider in the world, that isn’t our goal; we don’t want to be so large that we outgrow our personal touch. Our reputation for being trustworthy is based on this approach, along with delivering what we promise. Of course, we are expanding but in a sizable way to ensure we maintain our extensive quality service.
DA: How has the COVID-19 pandemic changed how clinical trials are run and whether there are any new opportunities that have arisen from this kind of paradigm shift?
AF: The pandemic ushered in a new way of thinking about how to work around in-person limitations, for instance, how to move forward with monitoring visits without being able to enter a hospital. This created the need for digitization and a move to virtual trials.
However, we see that, in Europe, patients are coming back in higher numbers, often because they couldn’t get diagnosed over the last 15 months or so. As of now, this has been very beneficial for the industry, because there’s a broad pool of accessible patients across various indications; it’s an opportune time to start any clinical trial.
Taking a longer-term view, it’s still unknown how the industry will change. Regulations are so varied from country to country; however, if the main regulatory bodies were to actively seek to harmonize regulations as much as possible, running clinical trials would be easier for the patient, for the CROs, for the supply chain providers, and for the sponsors. The pandemic demonstrated that there are mechanisms in place to accelerate the approval process for vaccines — there are ways this is already improving. A global initiative toward harmonization would remove many limitations and benefit the entire industry.
DA: How do you predict clinical trials evolving over the next decade — and what is SanaClis doing to anticipate those changing needs and build up the capabilities that will be in demand?
AF: I truly believe in taking a traditional approach and creating a culture based on personal involvement — whether it’s the doctor or CRA. SanaClis does a lot of remote monitoring visits, but, in every situation, we maintain a hands-on approach. I expect this to be true as the industry continues to transform into a virtual ecosystem.
DA: Are there any new capabilities or investments in technology that have enhanced the SanaClis service offering?
AF: We definitely try to stay on track with investing in new technologies and we would like to develop these tools internally. We’re very proud of our inventory management system — it’s possible to visualize every single kit, whether it’s in a manufacturing site or already in our depot. The system tells the entire manufacturing and temperature chain history — we track all data. An example of this diligence is that we alert project managers internally and on the client-side at least three months in advance of an expiration date and work on a shelf-life extension.
DA: Are companies increasingly seeking an integrated bundle of services from one provider like what SanaClis offers?
AF: Companies that haven’t worked with us before often have an issue understanding exactly what we offer. We hear, “are you a CRO? Or “are you a supply chain provider, or a sourcing company — what exactly are you doing?” From the first impression, it’s not always easy to convey the benefits we offer by providing many solutions. However, we see that more companies are increasingly willing to understand.
We see the demand, especially from the biotech companies — and even more so from virtual pharma — that are eager to have one subject matter expert in everything. Likewise, the subject matter expert wants to have a counterpart in a solution provider who can cover all of these needs. As of now, this is a niche environment for us, and we are trying to catch the attention of these kinds of companies. Of course, there are other companies we have worked with for a long time who are accustomed to and value our integrated solutions.
DA: What do you think the next big disrupter will be that’s going to change how things are done?
AF: The next big disrupter will be a way to decrease the time to market. As the protocols grow more complex, the time to deliver them gets longer. If the regulatory bodies could initiate a broader approach to the process of fast-track approvals, it could be a game-changer. Of course, I know that all the regulatory agencies are overloaded, but perhaps the pandemic could serve as a lesson learned for all governments internationally that these agencies deserve to have more staff so they can react more accurately and promptly to situations as they occur.
DA: Finally, what can you tell me about your vision for where SanaClis will be over the next 5–10 years?
AF: We’re celebrating our 21st anniversary. Having 20 years of existence, experience, and results gives us a great start to head into the next two decades. Though it’s hard to predict exactly how we will grow, we will maintain our identity as a client-focused company. Our projections for 2021 are already 20% above the yearly projections, which is an indicator we’re continuing to progress in the right direction.