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Clinical Trials

Regulatory Affairs 


Consultation regarding submissions

Preparation and management of clinical trial application to the Hungarian Regulatory Authority and CEC

Submission of substantial amendments

Submission of end-of-trial and study outcome report


Feasibility and Site Selection


Investigator databases in different disciplines

Site selection with a large patient pool in different indications


Clinical Monitoring


Highly educated and experienced professionals with diverse clinical backgrounds (physicians, pharmacists, biologists)

No fluctuation

Retain close contact with the investigators, study coordinators, pharmacists

High-quality monitoring services in compliance with applicable local laws and regulations, EU guidelines, and international standards

Professional handling of databases

Medical Monitoring


Medical doctors and medical specialists with relevant clinical experience and significant knowledge of clinical trials

Contact with study sites and study coordination

Patient safety is our main focus

Database handling

Medical Writing


Skilled personnel with proper knowledge of clinical trials and scientific writing

Clinical study report, patient documentation, protocol summary, safety reports


Local Project Management


Dedicated project manager for maintaining contact with global project managers, investigational sites/institutions, and Regulatory Authorities

Responsible for coordinating the team of highly experienced and qualified professionals assigned to each project

Responsible for contract management with investigators and institutions

Accompanied site visits and support of CRA's performance




Local contact to the Pharmacovigilance Department of the Regulatory Authority

Submission of PSURs, line listings, local SUSARs, literature monitoring

24 hours availability


Therapeutic Areas


Our therapeutic area experience is diverse and also includes bioequivalence and bioavailability studies and medical devices.


Full list of areas where we supported Phase I-IV clinical development:

  • Cardiovascular disease

  • Dental surgery

  • Implantology

  • Endocrine and metabolic disorders

  • Gastrointestinal disease

  • Gynecology

  • Infectious disease

  • Nephrology

  • Oncology

  • Respiratory

  • Rheumatology

  • Ophthalmology

  • Traumatology


Need more information?

We are here to assist. Contact us by phone, e-mail or via our website.

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