A CRA’s Guide to Clinical Trials in Bulgaria 🇧🇬
As a Senior Clinical Research Associate in Bulgaria, I've seen it all: the highs, the lows, and everything in between. Whether you're new to the scene or just curious about what it’s like conducting clinical trials in the land of yogurt, roses, and... questionable public transport, this guide is for you. From the art of negotiations, to navigating the maze of Bulgarian submissions, here’s your ultimate guide to surviving and thriving as a CRA in this corner of Eastern Europe.
Step 1: Find a Trial — Welcome to Bulgaria
Let’s start with the basics: why even conduct a clinical trial in Bulgaria? Well, the answer is simple — Bulgaria is actually a hidden gem in the world of clinical research. As a part of the post-socialist bloc, Bulgaria is surprisingly well-developed, especially in terms of education and healthcare. You’ll find that both men and women are well-educated (usually with a university degree) and hard-working. Doctors and healthcare professionals are still regarded as pillars of the community, even though their salaries are not exactly on par with those in Central or Western Europe.
Another massive bonus is Bulgaria’s patient population. It’s ideal for trials on heart disease, oncology, respiratory conditions, diabetes, obesity, and gastroenterology, as the number of patients suffering form these disease is significantly higher in comparison to other countries while at the same time - the patients could actually benefit form those trials! Conducting trials here not only benefits the sponsors but also the patients, offering access to cutting-edge treatments that might otherwise take years to arrive and not be wildly accessible to everyone.
Step 2: The Art of finding Doctors — Where Rakia and Research Collide
Now, on to the crucial part: finding the right doctors. If you’ve spent even a day in Bulgaria, you’ll know that the most reliable way to find anything is through “BG Mama” (yes, even your clinical trial). Other viable options include stalking the medical professionals on SuperDoc, Instagram, or Facebook. Networking events, business cocktails, conferences, and seminars are excellent opportunities to connect with doctors. One minute, you're discussing the latest advancements in clinical research over a glass of wine, and the next, you're exchanging contact information with a potential principal investigator for your study (this is what I call a fruitfull feasibility 😉). These professional gatherings often lead to valuable connections and collaborations in the Bulgarian clinical research community. The bond formed over a shared bottle of rakia is unbreakable — sort of like the clinical trials version of the "rakiavengers."
Step 3: Navigating Submissions with the Bulgarian Drug Agency (BDA)
If you think you've experienced bureaucracy before, prepare yourself for the unique experience of dealing with the Bulgarian Drug Agency (BDA). Submissions here, as it is usually dealing with state institutions, require a special approach. While perfectly organized folders and extensive paperwork are important, what's crucial is your attitude and preparation.
When visiting the BDA, remember these key points:
Always approach with a positive and respectful demeanour. You have to pay your respect 😅
Listen carefully to the staff's instructions and write down everything
Try to schedule an appointment in advance - while this is an unofficial rule, this helps ensure they're expecting you and can allocate time, given their typically heavy workload
Be patient and understanding - the process may take time, but maintaining a cooperative attitude goes a long way
Remember, the staff at the front desk, often referred to as "lelka" (auntie), are experienced professionals dealing with a high volume of submissions. Treat them with respect, follow their guidance, and you'll navigate the process much more smoothly.
I recently had a great personal experience that completely changed my perspective on dealing with administration work. When I started handling non-interventional studies - a type of trial I had never worked on before - I found myself lost in all the requirements for the submission documentation. Instead of struggling alone, I decided to call the BDA directly and ask. To my surprise, the woman who answered was incredibly helpful and well-prepared. She immediately started citing all the relevant regulations, where to find them, and how to prepare my submission. This experience taught me that sometimes, reaching out for help can save you a lot of time and stress. The BDA staff are often more than willing to guide you through the process, especially when you're dealing with unfamiliar territory.
Step 4: Negotiation — The Bulgarian Tax of Doing Everything
Welcome to Bulgaria, where negotiations aren’t just encouraged, they are necessary. Whether you're negotiating site budgets, contracts, or even where to grab lunch, you’ll have to flex those bargaining muscles - this is just a huge part of our culture, it would be considered rude if you don’t. Everything here involves an extra tax: the “doing everything you can’t even think of” tax. What does that mean? Well, it means get ready to explain everything five times, then re-explain it, and then explain it again — just for good measure.
Now, let's take a more serious look at the negotiation process. Different clinical sites have different Standard Operating Procedures (SOPs) and varying fee structures for their services. There's no one-size-fits-all solution, and as a CRA, you'll need to learn to be flexible while also knowing when to draw the line for yourself or the sponsor.
Site fees can vary wildly and may include:
Start-up fees
Pharmacy fees
IMP dispensation fees
Pharmacist fees
Administration fees
Annual agreement administration and implementation fees (my personal favorite!)
The bottom line is that you need to adapt and execute reasonable requests. Put yourself in the hospital's shoes. After all, you share a common goal: to get the study off the ground and bring new treatments to the patients who need them most. Remember, flexibility and understanding go a long way in successful negotiations.
Step 5: The Pre-Study Visit (PSV) and site selection — Expectations vs. Reality
Let’s set the scene: you are on your Pre-Study Visit (PSV). You've been told that this particular clinical site is perfect—an outstanding study team with enough experience to rival a NASA control room. They’ve promised to recruit at least 50+ patients and enter all data into the EDC within timelines and basically give you zero stress for the duration of the study. Sounds like a dream, right?
Fast forward to reality: you arrive at the site on your first RMV (routine monitoring visit):
The study team seems to have forgotten half of what you discussed during the site initiation, and the recruitment at this point is... well, let’s just say a little optimistic…and somehow, the air conditioning in the monitoring room is both broken (in July) and making a loud noise at the same time. But hey, it’s fine... right?
Take a deep breath, my fellow CRA, and repeat after me: “I can fix this!”
The first RMV can be challenging, and that’s perfectly normal. At this stage, both the study team and yourself are still getting familiar with how the protocol works in practice. Deviations are more likely to pop up at this point — like little gremlins you didn't see coming. So, what’s the key? Pay extra attention, take your time, and re-train if you must. It's not a failure to go over things again; it's an investment in the site's future success.
If you take the extra effort now — correcting issues, addressing questions, and reinforcing protocol expectations — you’ll save yourself (and the site) a mountain of work down the road. So, instead of panicking, set your site up for success. Be the calming presence in the chaos and guide your team through the early bumps.
Trust me, after this first RMV, it’ll be smooth(er) sailing—until the next fire, at least!
The Ultimate Secret to Clinical Trials in Bulgaria: Connections, Connections, Connections
If you take one thing away from this guide, let it be this: connections are everything. In Bulgaria, knowing the right people and getting to know the people who matter in the clinical research industry can be the difference between a seamless study and one that ends in chaos. That’s why I founded the Clinical Research Bulgaria community. I wanted to create a space where CRAs, doctors, and anyone interested in the field could connect, network, and share their stories. From organizing events to inviting guest lecturers, we’re building something special here. After all, it's not just about research—it's about the people who make it happen. And I am a huge believer in the personal approach and human connection.
*If you are interested to join, or you would like to follow our group and all networking events, we are on LinkedIn: Clinical Research Bulgaria.
You never really know where your next great opportunity may come from, so it's crucial to network like an Olympic champion and always keep your options open.
I personally had a couple of great opportunities myself, precisely because of my network:
➡️ I was invited to write an article for the Pharma Focus Asia magazine, which landed on the cover! (here is the link to the article, part of it is also available in my blog) I am currently working on my next piece for Pharma Focus Europe.
➡️ I connected with my long-time career mentor and role model, Dan Sfera, who I'm sure has helped many CRAs on their way to success. I had the chance to meet him and talk — we even recorded a podcast together (here is the link, if you are interested, we do talk about what is like to be an eastern European CRA)
➡️ Finally, it's my personal belief that I landed my new role with Cromos because of my following— the algorithm worked brilliantly in my favour and connected me with liked minded people, who are now my teammates.
Stay connected people! ✌️
A Little About Me and My Wild Ride with Cromos Pharma
In case you were wondering, I’m currently the sole representative for Cromos Pharma in Bulgaria 🇧🇬 (for now). That’s right, I have been flying the Cromos flag solo. The past three months since I joined the company have been a whirlwind, to say the least, but nevertheless amazing! While it's a tremendous privilege to represent Cromos in Bulgaria, it also comes with significant responsibility. As the sole face of the company here, I'm committed to showcasing our best qualities and capabilities at all times. It's been an awesome experience to be part of such a forward-thinking organization. Cromos's proactive approach and innovative mindset provide me with ample opportunities to excel in my role. What's particularly gratifying is the balance they strike – I have the freedom to tailor our operations to the unique Bulgarian landscape while still benefiting from the support and resources of an internatinal company. This blend of autonomy and backing allows me to leverage my local expertise effectively, ensuring we make a meaningful impact in the Bulgarian clinical research scene. And by the way, we do have an awesome podcast!
I did have to convince quite a few people though, that we’re a legit company, despite not having a fancy office in Sofia. It turns out, working remotely is still a pretty strange concept in Bulgaria (shocking, I know).
Another huge personal milestone for me in the past few months — I got married! 👰🏼♀️ Married life has been an amazing experience, full of love and laughter. But along with the joy of tying the knot, I quickly realized that getting my name changed was going to be a bit more complicated than just updating my Instagram handle.
In addition to updating your name on personal documents like your address, passport, ID, and driving license, you'll also need to revise a few work-related documents.
You see, being the sole representative for several sponsors in Bulgaria meant I had to get all of my authorization documentation signed again. Every single piece, which, by the way, I had just obtained a few weeks prior, when I joined the company. So, while I was basking in newlywed bliss, I also had to explain to the project managers for each of my studies why the same person (me) suddenly had a different last name.
PS: And I am still waiting for my new driving license to be issued.
Final Thoughts
Clinical trials in Bulgaria are a unique blend of chaos, charm, and opportunity. Whether you're figuring out your communication strategy with the BDA, making lifelong friends over rakia, or building a network of healthcare professionals, one thing is clear: it’s never boring. And if you're a CRA looking to make your mark, Bulgaria is the place to be.