HungaroTrial
A Holistic Path to Clinical Success

HungaroTrial stands out as a contract research organisation (CRO) that helps healthcare organisations—whether pharmaceuticals, biotechnology or medical devices—navigate the complexities of clinical development. From developing winning strategies to streamlining trial processes and adapting to regional nuances, HungaroTrial is there to guide clients through every phase of their clinical journey.

With offices in 10 countries, HungaroTrial has built a strong presence in Central and Eastern Europe (CEE). This reach expanded in 2023 when it opened a U.S. office in Atlanta. The company’s growth continues with plans to establish a business development office in South Korea in 2024, solidifying its global footprint.

HungaroTrial’s global presence is not just about locations—it’s about elevating the quality of clinical developments worldwide. With expertise in study design, management and monitoring, it leverages its extensive network of trusted key opinion leaders (KOL) and deep-rooted relationships across the CEE region. Its medical team, consisting of 12 experienced doctors, pharmacists and biologists, collaborates with clinical thought leaders to optimise trial site selection and boost patient recruitment. This blend of local expertise with global ambitions enables HungaroTrial to fine-tune every element of a client’s study management plan, aligning it with rigorous scientific standards, ethical considerations and local healthcare norms, creating protocols that drive clinical trials toward excellence on the global stage.

A testament to HungaroTrial’s capabilities is evident in their handling of a Phase II pneumonia study for a U.S.-based biotech company. When the company faced patient enrolment challenges in the U.S., HungaroTrial stepped in and identified high-performing clinical sites in CEE. Within nine months, HungaroTrial enrolled 420 patients—97 percent of the total needed—surpassing the client’s expectations and completing the project ahead of schedule.

Decades of experience in CEE clinical trial regulation have allowed HungaroTrial to refine its operational systems, ensuring compliance with ever-changing and complex local regulations. Its deep understanding of regulatory expectations—both formal and informal—facilitates seamless communication with national regulatory bodies, speeding up the approval process. To further enhance this capability, HungaroTrial has established local regulatory officers in each country of operation. These officers are responsible for staying current with regulatory developments, training staff and ensuring the highest quality of clinical trial applications. This proactive approach allows HungaroTrial to maintain compliance and stay ahead of evolving regulations while delivering superior trial outcomes.

Key to this process are the Clinical Research Associates (CRA), who work closely with site staff and investigators to keep trials on track. Their role goes beyond managing operations; they build relationships that facilitate clear communication and oversee critical aspects of trial setup. From organizing meetings to navigating the Ethics Committee and Institutional Review Board (EC/IRB) submissions to managing contract negotiations, the CRAs drive a collaborative process that streamlines trial execution and ensures compliance from start to finish. Their involvement is essential in keeping the trials moving efficiently, transitioning smoothly through each phase.

I work with highly skilled and experienced professionals in this field to help medical manufacturers to navigate the path of medical device regulation, get the CE marking and prepare, support and perform clinical investigations for medical devices that need clinical data

That same spirit of collaboration and dedication defines HungaroTrial’s approach to medical device trials. An experienced and specialised team not only guides device designs from concept to market but provides full-service clinical trials with comprehensive regulatory consulting for MDR compliance and CE Mark acquisition.

“I work with highly skilled and experienced professionals in this field to help medical manufacturers to navigate the path of medical device regulation, get the CE marking and prepare, support and perform clinical investigations for medical devices that need clinical data,” says Antal Solyom, director of the medical device unit.

Through its medical monitoring services and a dedicated pharmacovigilance team, HungaroTrial ensures patient eligibility is rigorously assessed and adverse events are immediately reported. This close attention to patient safety is complemented by a robust data management team that handles the indexing, analysis and reporting of trial data.

Ensuring every phase of clinical development is executed with precision, speed and scientific rigour, HungaryTrial is at the forefront of advancing healthcare innovation, bringing life-changing therapies and medical devices to market with efficiency and integrity.