Clinical development /
Phase I-IV. services

We provide exceptional study design, management, monitoring, and reporting expertise for our partners to support their confident decisions for successful clinical development. Our network in the medical community of the CEE Region and long-term KOL connections ensure optimal trial site selection and enrolment rates for our Clients.

Protocol Design

HungaroTrial’s experienced Medical Team includes 12 medical doctors, as well as supporting pharmacists aand biologists. In addition, we are able to tap into a wide regional network of recognized clinical thought leaders (KOLs), forming the right team to help you navigate key clinical trial challenges, including protocol design. We analyze every aspect of your study project management plan, aligning scientific, ethical, and standard of care parameters to develop a study protocol that delivers excellence, preserves, transparency, and drives patient recruitment.

Medical Writing

Our medical writing team has extensive experience developing clinical trial assets, informed consent forms, study protocols, and investigator brochures, following all applicable ICH Guidelines and GCP requirements to the highest standard.

Regulatory Applications

HungaroTrial has decades of experience in Central and Eastern Europe clinical trial regulation. We have developed and refined an operatonal system that allows us to comply with dynamic, complex local regulations. We understand regulator expectations – both official and informal – and communicate with applicable national bodies quickly and efficiently. To that end, we have established a Local Regulatory Officer in each country of operation. The office is responsible for staying up-to-date on local regulation, training staff, and safeguarding the quality of clinical trial applications.

Clinical Operations

Clinical trial monitoring and site management services are provided by qualified, knowledgeable professionals with extensive clinical research and therapeutic area experience. Our CRAs deliver a spectrum of site management and monitoring functions, including trial site identification, qualification and selection, budget and contract negotiations, ongoing site monitoring and management, support for logistics, regulatory document collection, review and submission, and Electronic Trial Master File (eTMF) setup and maintenance.

Medical Monitoring

Clinicians with specific and relevant therapeutic experience drive every decision regarding a patient’s prospective enrollment, evaluating for eligibility and possible adverse events. Over time, we monitor trial data closely to proactively look for adverse events patterns, ensuring a high level of integrity as your patients progress through your clinical trial.

Pharmacovigilance

A qualified and experienced pharmacovigilance (PV) group is responsible for completing all safety reporting within the timeframe defined by local regulators. Additionally, our PV team carefully designs safety systems and protocols that safeguard patients from enlistment to completion.

Data Management and Statistics

We help drive crucial clinical trial data initiatives, including indexing, management, analysis, and final report creation. Specific functions include statistical analysis planning and reporting, sample determination, CRF design and correction, database design and development, database validation, data entry (simple/double), querie solving, codification and encryption.

Explore how we lead our Sponsors to Success in Phase I-IV. clinical development

COVID-19 medication study for a Korean Sponsor

HungaroTrial successfully managed a phase II./III. clinical trial for a Korean Sponsor researching a new COVID-19 medication. The trial was based in Serbia and Macedonia. HungaroTrial managed to enrol 103 patients in just 11 days, ensuring a timely completion of the study. HungaroTrial managed to

secure fast track approvals in both countries
ensure a quick start-up, including fast contract signature
select excellent sites with proven enrolment potential
conduct fast data base cleaning for interim analyses (85% of the study data were generated in 28 days and cleaned in less than 1 month).

Phase I study in Peripheral Arterial Occlusion (PAO)

A US-based biotech company initiated a Phase I. clinical trial in the US, South Africa and Brazil to develop a compound for the treatment of Peripheral Arterial Occlusion.

Since the enrolment rate was far below the expectations of upper management, the Sponsor decided to extend the project to three Central and Eastern European countries with the help of HungaroTrial.We managed to set up new trial sites in Hungary, Serbia and Romania within a short time. Due to the high activity and productivity of the trial sites, the average time to close a cohort was reduced from 157 days to 64 days. In this way HungaroTrial made it possible for the Sponsor to save one year of development time.

This success of the Phase I trial led HungaroTrial to win the Phase II study of this development program.

Phase III. study in Hypoparathyroidism indication

A US-based biotech company contacted HungaroTrial to execute a rescue project. The study began in the United States, but enrolment figures were far below the planned rate. Since the indication was for a rare disease and patient selection criteria were very limiting, it proved extremely difficult to find suitable trial sites and subjects.

Fortunately, HungaroTrial was able to quickly set up the project in Hungary, enrolling 26 patients instead of the contracted 18 patients- a 144% improvement over based on initial targets

Advance Your Program Today

HungaroTrial is ready to help you complete your clinical trial program on time and to the highest standards.

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Medical device trials and Colsultancy

HungaroTrial’s Expert Team is ready to assist medical device companies through all phases of product development by regulatory consultancy and clinical trial services, with special focus on MDD => MDR transition.

CRA Outsourcing

For over 20 years HungaroTrial has provided CRA sourcing services in most CEE countries. The best proof of our service’s quality is the long list of our repeat clients, including 7 of the TOP 10 global pharmaceutical companies.

Support for COVID-19 research

From the beginning of the pandemic, HungaroTrial has been very active in COVID-19 clinical research. Our colleagues are dedicated to add our clinical development knowledge, medical expertise and research infrastructure to the global efforts to find safe and effective COVID-19 medications.

Clinical development /Phase I-IV. services