Pavla Nevolová, country head of EastHORN in the Czech Republic, shares the historical roots of the now multinational Czech CRO. Nevolová also shares her insights into the recent evolution of the Czech clinical research landscape and its challenges and opportunities.
Pavla, could you please introduce yourself as country head of EastHORN?
I grew up in Prague and chose to pursue a career in the medical field as a paediatrician. I used to work ten years at the University Hospital Motol in Prague until I decided to switch into clinical research. I had worked six years as a Clinical Research Associate (CRA) and a Local Project Manager when EastHORN offered me to take the position of Clinical Operations Manager and Country Head of the Czech Republic, Slovakia, and the Baltics. We try to be very active on behalf of EastHORN in the clinical research landscape through associations, both at the local level with the ACRO-CZ, the Czech CRO association, of which I am a member of the board, and at a European level with EUCROF where I am a member of the pediatric working group.
What is your biggest achievement or milestone since joining EastHORN in 2013?
Without any doubt, my biggest achievement at EastHORN is building a strong team that I can always rely on. Once you have found the perfect team, great achievements occur every day! Some employees have been at EastHORN for even longer than me, some employees I have recruited myself personally and overall I am very satisfied with how we consolidated EastHORN’s team throughout the years. This is an achievement I value beyond any successful project, good results or key milestone because, with a perfectly functioning team, miracles are made possible every day thanks to our entire team made out of experienced CRAs and project managers.
Another big achievement is the fact that we are participating in almost all clinical trials run globally by EastHORN. Some clients do not have the idea to perform clinical trials in the Czech Republic at first but when we prepare the feasibility in such a convincing way, they change their approach and include the country. This is also thanks to our efficiency in patient recruitment. In seven years, we have not failed once in recruiting the required amount of patients for each trial. Thanks to very good referencing and an impressive track record, we are proud to position EastHORN Czech Republic as one of the pillars of the global CRO. This is even more satisfying considering the company, before moving its headquarters to Warsaw in Poland, was originally founded here in Prague.
Can you provide for our readers an overview of EastHORN’s footprint and clinical operations within the Czech Republic?
We are a full-service Contract Research Organization (CRO) founded in 2004, managing clinical trials from Phases I-IV. We take advantage of our network of local offices across Europe, continuously expanding and covering from Spain to Russia. EastHORN’s added value comes from these local offices which, through a team of experienced CRAs and professionals, bring the needed local knowledge. Our team’s expertise on the local regulations is a key asset in providing fast and comprehensive results.
In terms of service portfolio, we offer everything from feasibility studies to medical monitoring and writing, including pharmacovigilance, regulatory service and so on. I would also like to stress that our experience in Phase I and bioequivalence studies are extraordinary.
What is EastHORN’s vision and how do you continue to remain true to your roots and heritage at the Czech Republic affiliate?
EastHORN was founded with the vision of incorporating the best practices from multinational organizations with high standards but as a smaller company that would capitalize on its agility and ability to listen to their customers to go beyond their expectations. We have centralized EastHORN’s growth around avoiding drawbacks we can see in global companies, such as the lack of employees empowerment to take decisions or be proactive and think outside the box. We do not see our employees as timesheet hours and we never want them to consider their job as such either. EastHORN is committed to its partners and is not just following processes, but offering the best solutions. We want to focus all of our attention on delivering results through effective and open communication, fast decision-making process and encouraging creative ideas to push our projects forward.
Our ultimate objective is to create the perfect workplace for our team so they can be happy, dedicated and as enthusiastic as can be. Therefore, at EastHORN there is no individual competition, we continuously promote teamwork and have eliminated a hierarchical structure that limits our employees’ room for growth.
What are some of the therapeutic areas that EastHORN covers?
We currently have ongoing trials in neurology, oncology, medical devices but we can cover any therapeutic area. One of our main focuses is to attract more projects for cannabis-derived substances. We see that it is a trending topic and the Czech Republic has the perfect regulatory environment to become the leading market to research in that field. Here we do not doubt the infinite potential of this kind of medicines and it is a very interesting field for clinical research. In 2018, EastHORN ran a study of Sativex, on behalf of Almirall, and the Czech Republic was the main country for this important project. It had 200 patients over a rather small time period and the data was used successfully to qualify the product for reimbursement by the German healthcare system.
We also rescue some unsuccessful projects coming from other CROs, we took over the clinical trial looking at a unilateral acute hearing loss and some oncology trials. We have an impressive track record in the Phase I trials and bioequivalence trials as well. We operate through well-established cooperation with pharmacological units on Phase I trials in the country. EastHORN in the Czech Republic has a large experience in medical devices as well. We have a project manager here in Prague specialized in this specific area and we passed regulatory approvals several times already. Our project managers are involved in multinational trials, not only covering the Czech republic but taking part in the different projects EastHORN runs globally.
Looking at the Czech clinical research landscape, what are the advantages of conducting clinical trials in the country?
On the one hand, all of the regulations are very clear, transparent and easy to follow. The regulator, the State Institute for Drug Control (SUKL) can often come back with comments following a submission of a clinical trial, but I think that is an advantage as well. These comments are always very scientific and useful, it is also very easy to receive advice from SUKL, so their reliability and fairness are a real asset for the clinical research landscape in the Czech Republic.
On the other hand, the Czech Republic is also endowed with good healthcare standards and advanced infrastructures, this also contributes to the creation of quality and reliable data of which we can take advantage to provide the best possible service to our customers.
I also believe that, despite the low unemployment rate that the Czech Republic is experiencing and especially in Prague, the country has a great pool of highly qualified medical and para-medical personnel. Of course, it is not easy to attract experienced candidates in the beginning, but then as a manager, it is your role to help them grow and achieve their maximum potential. Loyalty toward EastHORN will then be the logical consequence of providing continuous training, decision power, room for growth within the company and a nice workplace to come to every day to each and every one of them. The most difficult is, of course, to keep them motivated over the years as we evolve in a highly competitive environment. However, our team stays stable because they love it here and, for this managerial challenge, I try to lead by my example as I am a very enthusiastic person myself.
Finally, what are some of the challenges that EastHORN faces in the Czech Republic and how do you think they could be overcome?
Well, first of all, I would like to express how impressed I am to see the support of Adam Vojtěch, the Minister of Health when reading his foreword for the Czech Republic Healthcare & Life Sciences Review 2020. I am happy to see that he is ready to bring the Czech Republic healthcare system and research to the next level, in line with the country’s Innovation Strategy, through having more open discussions. The Minister of Health is willing to have a more open dialogue and work with the industry on some issues the country faces, like the local reduction of the number of clinical trials. The reason behind this reduction is not that evident but has significantly changed the clinical research landscape so that is great news that the government is taking steps to tackle this tendency.
Clinical trials are way more advanced and demanding than they used to be ten years ago. The growing number of large hospitals equipped with the latest innovations and ability to collect precise and reliable data is a huge asset for CROs supporting clinical trials and the development of these departments. I believe that the industry associations are an important driver of the rise of the Czech healthcare. These associations facilitate the communication between the members of the industry and the authorities and present a shared vision and a united front that has more impact on the key decision-makers. I think this new voice we have really made a difference in recent years and that positive changes are still to come thanks to the associations.
