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

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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

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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

 

Pharmacovigilance

 

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