SMO in Hungary

Swan Med Hungary Kft is an organization that specializes in managing clinical research sites.

We have a great network of clinical research sites which we manage and work with dedicatedly.

We provide services for CRO’s, pharmaceutical companies, biotechnology companies, medical device companies and even clinical research sites.

We offer project feasibility, investigator selection, submission of documents for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval, patient counseling, patient recruitment, patient follow-up, informed consent form (ICF) translation into vernacular languages etc.

We help in recruiting patients as per the study protocol, ensuring the study subjects are informed about the study procedures, visit schedules, laboratory procedures etc. Also helps the site with all documentation related work such as keeping the site files up to date at all times, maintaining study specific logs such as temperature log, drug accountability log, patient’s diaries, storing the drugs according to the protocol, submission of documents to ethics committee etc.

We help the investigator concentrate on the patient recruitment, reducing the burden of the investigator and cost & time of the sponsor.

Clinics

Gastroenterology Research Center Unit within the Main Railway Outpatient Clinic

Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft Debreceni Egészségügyi Központja
Hungary 4025 Debrecen Erzsébet Str 11-13. in Hungary

Introduction:

The Main Railway Heath Center Outpatient Clinic has been founded more than 70 years ago.It is stated in Debrecen Hungary and perform outpatient service in various medical fields for the citizens. Our

Gastroenterology Unit has been founded in 2007 and conducting studies from 2011.

Several phase 3 and phase 2 study has been performed with Colitis Ulcerosa,Crohn disease, Obstipation, Ulcer indications.

The Institute has own laboratory,Ultrasound, and X-ray Unit, and separate study room, for Clinical study patients. 

Érmellék Health Center

Research Center within the Létavértes Outpatient Clinic in Hungary

Introduction:

Érmellék Health Center (Swan Med Hungary Ltd) is an organization that specializes in conducting clinical trials in various medical fields,placed in Létavértes, which is about 23 km far from Debrecen Hajdú Bihar County.

We have a great network of Specialist and General Practicioners that works full or part time in the Institute and also part of the clinical research site, and dedicated and professionals in their field. Our Investigators have a huge potential study patient database and great connection with other specialists and also experience in clinical trials.

We provide services for CRO’s, pharmaceutical companies, biotechnology companies, medical device companies and be able to conduct Phase II,III,IV, observational and medical device studies. We offer to conduct studies from the beginning until the end with great efficiency.

We help the investigator concentrate on the patient recruitment, reducing the burden of the investigator and cost & time of the sponsor.

Facility:

Our facility moved to a brand new Medical Institution named: Érmellék Health Center in Létavértes which is very close to Debrecen and a melting pot of 8 township: – Álmosd, Bagamér, Esztár, Hajdúbagos, Kokad, Létavértes, Monostorpályi, Pocsaj, and was built in September 2011.

This Institution is set up with the newest equipments and modern technical facilities, to suit for the highest standards.

We are present int he following medical fields:

  • Pulmonology
  • Cardiology
  • Diabetology
  • Rheumatology
  • Internal Medicine
  • General Surgery
  • General Gynecology
  • General Pediatrics
  • General Otolaryngology
  • General Ophtalmolgy
  • General Dearmatology and STD
  • General Neurology
  • Orthopaedics
  • Urology
  • Psychiatry
  • From 2014 summer: Endocrinology,
  • Rehabilitation (adult,children)

Additional Departments:

  • Laboratory :HQ-Lab Ltd,
  • Ultrasound,
  • X-Ray,
  • ECG, Holter ECG,
  • Physiotherapy,
  • Massage,
  • Infusion therapies

 

Also there is a unique facility called „daytime hospital” where we can offer chance to conduct infusion therapies for 12 hours at the facility.

Our center is also have professional safety equipments.

Trial history:

  • We have been conducted already 6 studies int he past.The first ones were conducted in our previous location in Debrecen Railway Medical Center Ltd.
  • Phase III Gastroenterology IBD study ( expected 3 patients enrolled 1)
  • Phase IIb. Gastroenterology Crohn Disease study ( expected 3 patients enrolled 5)
  • Phase III. Gastroenterology Colitis Ulcerosa study (expected 5 patients enrolled 7 yet)
  • Phase II. Gastroenterology Colitis Ulcerosa study ( expected 3 patients enrolled 6 yet)
  • Phase III. Internal Medicine Obstipation study ( expected 5 patients enrolled 10 yet)
  • Phase III. Ophtalmology study (expected 10-15 patients enrolled 51 )
  • SIV planned: Phase II. Gastroenterology Diverticulitis study, Phase III Gastroenterology Lymphatic colitis study, Phase III Gastroenterology Microscopis colitis study

Organizator:

Dr. G Kiss Orsolya

Doctor, GP, Clinical Pharmacologist

Background:

I have started my medical education at University of Debrecen, Center of Medical Health Science, and gained my diploma in 2005.In 2009 I received my Specialization in General Practice at National Health profession and post-secondary vocational Training Committee in Debrecen, Hungary and in 2012 the Specialization in Clinical Pharmacologist at National Health professional and post-secondary vocational Training Committee in Budapest, Hungary.

I have been working previously in several CROs and Pharma Companies as a senior CRA (Clinical Research Associate) int he past.And then I started to work as an Investigator in Swan Med Hungary Kft and started clinical trials in Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. (Debrecen Railway Medical Center Ltd )Debrecen since 2012. I have been involved in several trials since- Phase II and III studies.

In 2012 we founded Swan Med Hungary Ltd which main function is to conducting trials in Érmellék Health Center in Létavértes with the specialist doctors working in the Institution.

Valid GCP certificate and IATA training certificate 2013.