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PHASE I PATIENT UNIT - SGS · The unit was created to significantly increase reach and patient...
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SGS PHASE I PATIENT UNIT MEDICAL CENTER OF DEFENSE FORCES, BUDAPEST, HUNGARY SITE INFORMATION The Medical Center of Defense Forces is a renowned and leading facility within Hungary. This large health care center is open to the public (beyond military health care). Located within the medical center, this Phase I Patient Unit has a five bed capacity for early phase clinical trials in patients. The safety and quality of the studies is ensured thanks to a staff of highly experienced and multilingual professionals: ■ Operational ownership by SGS medical staff and investigator ■ 24/7 medical control of trial participants ■ Full time availability of hospital emergency staff ■ The hospital is staffed by more than 200 physicians, supporting 1,100 beds. ADDED VALUE IN CLINICAL TRIALS ■ Five bed capacity allows for easy and flexible allocation ■ Located within the Oncology ward, but separated from standard Oncology practice, this clinical trial unit is capable of conducting phase I-IIa trials in any requested indication ■ Close collaboration of hospital physicians and on-site SGS team resulting in solid recruitment capacity for patients, rapid subject enrollment and on-time study delivery ■ An experienced SGS team of investigators, research physicians, clinical project managers, nurses, and clinical research coordinators, as demonstrated in various indications and early phase trials. EXPERIENCE & THERAPEUTIC AREAS The hospital has been conducting patient clinical studies for more than 15 years. Key hospital physicians collaborate with SGS to conduct these studies. We offer a full service package with complete project oversight and dedicated therapeutic expertise. The hospital primarily focuses on Oncology trials. Approximately 40 clinical trials - phase I to III - have been conducted the last four years, covering indications such as soft tissue and bone tumors, gastrointestinal tumors: oral cavity, GIST, pancreatic cancer, rectal cancer, genitourinary tract malignancies, breast cancer, prostate cancer, melanoma, etc. In addition to the oncology trials, the hospital also conducted trials in: • Cardiology • Rheumatology and immunology • Dermatology • Organ impairment • Metabolic disorders The Phase I Patient Unit at Medical Center of Defense Forces hospital is part of the SGS Life Science clinical trial network. This unit supports early phase patient clinical trials, providing access to patient populations, and working as a qualified site for enrollment and study conduct. In Association With
Transcript of PHASE I PATIENT UNIT - SGS · The unit was created to significantly increase reach and patient...
SGS
PHASE I PATIENT UNITMEDICAL CENTER OF DEFENSE FORCES, BUDAPEST, HUNGARY
SITE INFORMATIONThe Medical Center of Defense Forces
is a renowned and leading facility within
Hungary. This large health care center is
open to the public (beyond military health
care). Located within the medical center,
this Phase I Patient Unit has a five bed
capacity for early phase clinical trials in
patients.
The safety and quality of the studies
is ensured thanks to a staff of
highly experienced and multilingual
professionals:
■ Operational ownership by SGS
medical staff and investigator
■ 24/7 medical control of trial
participants
■ Full time availability of hospital
emergency staff
■ The hospital is staffed by more than
200 physicians, supporting 1,100
beds.
ADDED VALUE IN CLINICAL TRIALS ■ Five bed capacity allows for easy and
flexible allocation
■ Located within the Oncology
ward, but separated from standard
Oncology practice, this clinical trial
unit is capable of conducting phase
I-IIa trials in any requested indication
■ Close collaboration of hospital
physicians and on-site SGS team
resulting in solid recruitment capacity
for patients, rapid subject enrollment
and on-time study delivery
■ An experienced SGS team of
investigators, research physicians,
clinical project managers, nurses,
and clinical research coordinators, as
demonstrated in various indications
and early phase trials.
EXPERIENCE & THERAPEUTIC AREASThe hospital has been conducting patient
clinical studies for more than 15 years.
Key hospital physicians collaborate with
SGS to conduct these studies.
We offer a full service package with
complete project oversight and dedicated
therapeutic expertise.
The hospital primarily focuses on
Oncology trials. Approximately 40
clinical trials - phase I to III - have been
conducted the last four years, covering
indications such as soft tissue and bone
tumors, gastrointestinal tumors: oral
cavity, GIST, pancreatic cancer, rectal
cancer, genitourinary tract malignancies,
breast cancer, prostate cancer,
melanoma, etc.
In addition to the oncology trials, the
hospital also conducted trials in:
• Cardiology
• Rheumatology and immunology
• Dermatology
• Organ impairment
• Metabolic disorders
The Phase I Patient Unit at Medical Center of Defense Forces hospital is part of the SGS Life Science clinical trial network. This unit supports early phase patient clinical trials, providing access to patient populations, and working as a qualified site for enrollment and study conduct.
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CONTACT INFORMATION
FACILITIESThe Phase I Unit for patient studies
currently occupies a separate and
secured wing in the Oncology ward, in
close proximity to the intensive care unit
of the hospital. In addition to the five
beds for patients, the unit is equipped
with an examination room, a sample
preparation area, a sample storage area/
locker, and rest-rooms adequate for
multi-day stays.
The Medical Center of Defense Forces
hospital, being a large health care center,
includes all typical support services.
Pharmacy and Lab, with its experienced
staff, are fully adapted to support patient
studies under controlled procedures.
PATIENT RECRUITMENT & STUDY EXECUTIONThe unit was created to significantly
increase reach and patient trial
capabilities in early phase clinical trials
within Hungary. This Phase I Patient Unit
has constant and reliable access to most
of the patient populations treated in
the institution which consists of several
campuses.
The Phase I Unit plays a crucial role in
the early phase studies conducted by our
clinical research personnel and clinical
project managers. As part of the SGS
Life Science clinical network, this unit
can operate as single unit or in a multi-
site approach, depending on the needs
of the study.
Clinical trial safety and quality are primary
concerns throughout the entire study,
and the professional staff at this hospital
are there to provide full support, such as
crash teams on stand-by 24/7.
MEDICAL CENTER & SGS SUPPORTING PHYSICIANSHospital and SGS teams work together
to ensure the best scientific support and
project management. Prof. Dr. Zsuzsanna
Papai (Medical Center of Defense Forces
Hospital) and Dr. Istvan Udvaros (SGS)
are the reference physicians.
• Oncology: Prof. Dr. Zsuzsanna Papai
• Cardiology: Prof. Dr. Robert Kiss
• Rheumatology / Immunology:
Dr. Ilona Ujfalussy
• Dermatology: Dr. Adrienne Vajda
• Organ Impairment / Metabolic
Disorders: Prof. Dr. Albert Csazar
• Neurology: Dr. Zoltan Szakacs
SGS CLINICAL RESEARCH
Generaal de Wittelaan 19A Bus 5
2800 Mechelen, Belgium
Tel: + 32 15 27 32 45
Email: [email protected]
WWW.SGS.COM/CRO
MEDICAL CENTER OF DEFENSE FORCES
1062 Budapest,
Podmaniczky utca 109-111
Hungary
SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY
