Fast study start up and patient recruitment
We offer clinical research services across a broad spectrum of therapeutic areas, including Oncology, Respiratory, Cardiovascular, CNS, Rare disease, Infectiology and many others. Our experience lets us facilitate the complex clinical trials and provide tailored solutions for pharmaceutical and biotechnology companies.Detailed experience list
For further information about our experience in other therapeutic areas
Phase I. clinical trials
HungaroTrial has extensive experience facilitating single or multi-center phase I. clinical trials. We have partnered with Central and Eastern Europe’s leading Phase I. Units to help companies assess the following properties across medically diverse patient populations:
- Drug-drug interactions
- Bioequivalence (in close partnership with three clinical pharmacologic units, we provide independent, experienced monitoring services)
- Dose Finding
- Cardiovascular Risk Assessment
Throughout the entire process, we pay close attention to the safety of trial subjects by setting up and managing Data Safety Monitoring Board (DSMB) operations. We ensure optimal data quality through close monitoring by Senior CRA staff.
Phase II-III. clinical trials
HungaroTrial excels at study design, planning, and executional support for Phase II-III. clinical trials:
- Senior staff, comprised of experienced full-time physicians, provides strategic direction throughout the entire process, ensuring your study proceeds with the rigor needed to meet key clinical and regulatory imperatives
- Long-standing relationships with regional academic and clinical opinion leaders ensure we bring the right perspective to every project
- Ongoing, close collaboration with high-volume patient recruitment sites – both academic- and independent-affiliated – help us ensure fast enrolment and start-up without sacrificing quality
- Rigorous and routine training keeps our Clinical Team’s working knowledge as contemporary and valuable as possible
Beyond clinical and medical operations, our dedicated Regulatory Team helps customers navigate complex and dynamic regulatory landscapes:
- We stay abreast of the most current regulations, notices, and regional events to ensure your trial documentation makes an excellent impression when it matters most
- Locally based Regulatory Officers help optimize clinical trial approval time in each country of operation
- Team members possess deep experience in DSMB management
HungaroTrial has a rich history facilitating successful rescue trial sites in the CEE region. We help our partners save time, resources, and stress by leveraging our infrastructure, relationships, and experience to achieve results quickly and reliably.
Here are just some of the many examples we can proudly speak to:
Phase II. study in Peripheral Arterial Occlusion (PAO)
HungaroTrial managed the patient enrolment is Bulgaria, Czech Republic, Poland, Romania, Serbia, Slovakia and Ukraine and enrolled 125 patients from the total patient number of 165.
We saved over one year of development time for the US Biotech Client by boosting the enrolment in Central and Eastern Europe.
Phase II. study in Pneumonia indication
A US-based biotech company contracted HungaroTrial for a Pneumonia study. Patient enrollment began in the United States, but the team encountered difficulties and turned to us for help.
To assist the Client, HungaroTrial selected case-appropriate and productive sites in Central and Eastern Europe. Subsequently, we were able to enroll the required number of patients in a comparatively short time and completed this infectology project before the planned deadline. HungaroTrial countries enrolled 420 patients within 9 months, which is the 97% of the total patient number.
Phase III. study in Anal fissure indication
A US-based biotech started a Phase III. Anal Fissure indication study in the USA, Canada and Israel. Due to slow recruitment from the initial sites, HungaroTrial was contacted to initiate a rescue study.
HungaroTrial quickly moved from agreement to setting up sites in Poland, Ukraine, and Bulgaria and proceeded to enroll the required number of patients in two months. Due to the hard work of the HT team, the initiation and completion of the study – from the first phone call with the sponsor to unlocking the project database for nearly 100 patients – was completed in only 10 months.
Rare disease studies
Successful management of rare disease clinical trials requires both a nuanced understanding of established protocols, as well as the ability to pilot novel approaches to day-to-day operations. At HungaroTrial, we have a strong track record of helping rare disease drug candidates reach regulatory approval.
Ongoing Pompe disease study
Pompe disease, also called Glycogen storage disease type II, is very rare and one of the most challenging indications. It affects about 1 in 40,000 people in the USA, and about 1 in 100,000 worldwide. There are less than 10 patients registered in Hungary and only 2 patients in the national registry of Bosnia at this moment who will be enrolled into the HungaroTrial’s project. HungaroTrial is managing sites in 7 countries for this ongoing trial: Bosnia, Bulgaria, Hungary, Poland, Romania, Slovakia, and Slovenia.
Phase II. rare disease trial in Tubular Sclerosis
The entire patient recruitment period was during the COVID-19 pandemic and it had a huge impact on the enrolment and availability of patients, still HungaroTrial managed the enroll rmore than 50% of the total patient number in the whole study (much more than US sites). In Hungary, Serbia, Slovakia and Czech Republic our sites performed extremely well, no delays were recorded during the study, all timelines were respected and all milestones were achieved.The trial site in Hungary, Bethesda Children’s Hospital, Budapest was the worldwide top enroller site in the study, with 18 patients.
Phase III. study in Epidermolysis bullosa indication
HungaroTrial enrolled 12% of the global patient number in less than a month.
This was a typical rescue project situation. The project was running for 2 years in the USA and Western European countries of which the enrolment was far below the plan.
HungaroTrial was approached after 2 years from the initiation in the USA and Western European sites, and HungaroTrial enrolled 20 patients in less than a month which was 12 % of 169 global patients for the study in total.
The global enrolment plan was completed and the study was rescued by the excellent performance of HungaroTrial.
HungaroTrial’s expert team can effectively support the planning, design, implementation, and evaluation of post-marketing clinical programs. We have successfully supported several post-marketing study initiatives in the past, including in the Therapeutic areas.
For more information on our work in this area, please contact the HungaroTrial Team.
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HungaroTrial is ready to help you complete your clinical trial program on time and to the highest standards.