krakowskie centrum osteoporozy i menopauzy

KRAKOWSKIE CENTRUM
MEDYCZNE
Director: Prof. Edward Czerwinski
tel. 4812 430 3209; fax (+) 430 3217, www.kcm.pl, [email protected]
ul. Kopernika 32
31-501 Kraków
Poland
Kraków, 16.11.2015
INFORMATION ABOUT CLINICAL TRIALS
FOR PHARMACEUTICAL COMPANIES
Krakow Medical Centre is a private medical center devoted to performing clinical trials, in which
we have been excelling for 22 years. We are prepared to implement advanced phase II-IV protocols in
internal medicine, cardiology, dermatology, bone and joint diseases, neurology, nephrology and more.
We have conducted 85 clinical trials in among others: psoriasis, osteoporosis, rheumatoid
arthritis, osteoarthritis, cardiology, hypertension, diabetes, ulcerative colitis, COPD, asthma, polycystic
kidney disease, migraine, gout, haemophilia. Per requirements of individual protocols we are able to form
a medical team of any profile.
The staff embraces 63 doctors including 24 medical professionals of various specialties with an
extensive experience in clinical trials and fluent English. The director of the Centre is Prof. Edward
Czerwinski, a former Head of Orthopaedic Clinic of the Collegium Medicum Jagiellonian University,
currently the Head of the Department of Bone and Joint Diseases Medical College Jagiellonian University,
who in the course of his 42 years of experience gained numerous diplomas of Polish and foreign
universities and conducted 43 clinical trials.
The principal investigators are specialists in the given field of medicine. We ensure a quick and
effective screening enrolment as well as a low drop-out. A study coordinator and an assistant assigned to
each project guarantees a smooth cooperation with a sponsor and CRO. Work of all the teams is
coordinated by the Trial Office. All procedures of the Site as well as the method of handling source
documentation are described in a detailed, internal SOP, which is continuously improved.
Each patient included in a clinical trial is under supervision of a medical doctor, who is available
24/7 via mobile phone. Prolonged experience of the personnel and modern equipment ensure high
standard of services. The personnel conduct trials with the utmost care and devotion. We are known as
one of the best sites in Europe and we have cooperated with companies from all over the world. So far,
the Centre has undergone seven external audits and for each we have received excellent assessment.
We possess a fully computerized database of 128,000 patients. In the field of recruitment we
cooperate with major multidisciplinary centres. We possess complete and modern set of diagnostic and
laboratory equipment, including equipment for bone densitometry (Hologic Horizon W), spine
morphometry, ultrasound system with a set of probes. We own the most modern ophthalmologic, X-Ray,
MRI (1,5T; 3,0T), QCT and mammography equipment (cooperation).
Regardless of the medical activities we also conduct research projects and health promotion
campaigns. The team organizes international congresses with a special focus on osteoporosis and helps to
manage the Polish Portal of Osteoporosis (www.osteoporoza.pl). Prof. E. Czerwinski is a well-known
specialist in the field of osteoporosis and orthopaedics, a member of several Scientific Boards of medical
journals, a member of several scientific societies at home and abroad, recognised by the IOF President's
Award in 2015. He is an author of 465 scientific papers resulting in IF65 (multisite studies 320).
The seat of the Company (700m2) is situated in a renowned Kopernika street, located among the
departments of the University Hospital in Krakow, which enables us to offer our patients the highest
quality of medical services. Adjacent to the main, renovated building with spacious and air-conditioned
rooms the Centre has its own car park and a picturesque garden. We are based within 7-minute walking
distance from the Main Railway Station and the Main Market Square.
Please visit www.kcm.pl for details and a virtual tour.
Director
Prof. Edward Czerwiński
CLINICAL TRIALS CENTRE
tel. + 4812 423 1722, fax (+) 430 3233
REGISTRATION
tel. +48 12 430 0000
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KRAKOW MEDICAL CENTRE
MEDICAL EQUIPMENT
Medical Imaging
1. Bone Densitometry DXA
1.1 Whole body Hologic Horizon W, software version APEX 5.5
1.2 Whole body Delphi W Hologic, software version 11:1:7
2. Radiology and Spinal Morphometry - collaboration
Shimadzu X-Ray machine, St Louis Children’s hospital 2 Strzelecka str.
3. Quantitative Computed Tomography - collaboration
Siemens, Somatom Selsapion 10, the Department of Radiology Coll. Med. UJ
4. Magnetic Resonance Imaging - collaboration
GE SIGNA HDxt 1,5T, Zakład Diagnostyki Obrazowej UJCM
GE SIGNA Excite 1,5T, Voxel 265 Wielicka str.
GE Discovery 750 3,0T, Voxel 1-3 Wrocławska str.
GE Signa Hde 1,5T, Centrum Medycyny Profilaktycznej
5. Mammography - collaboration
FLAT SE - Metaltronic
6. Ultrasonography: standard, Doppler, transvaginal
Logic LOGQ500, TOSHIBA, Model SSA 580A / Nemio XG
Premium, Model Mindray DC6
Ophthalmology
Auto Refractor (Topcon RM-8800)
Tonometer (Topcon CT-80)
Slit Lamp (Topcon SL-1E) with applanation tonometer (AT-500)
Skiaskop (Heine)
Opthalmoscop (Keeler)
Other
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Defibrillator AED Samaritan PAD (Heartsine)
Colposcope
Spirometr
ECG (Aspel A4 As Card)
Bone biopsy equipment
Stadiometer (Harpebden)
Glucometer (One Touch II)
Centrifuge
Refrigerator
Deep freezer (-70 ◦C)
CLINICAL TRIALS CENTRE
tel. + 4812 423 1722, fax (+) 430 3233
REGISTRATION
tel. +48 12 430 0000
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KRAKOW MEDICAL CENTRE
EXPERIENCE IN CLINICAL TRIALS
Krakow Medical Centre since 1997 – 18 years.
SMO - Site Management Organization
STAFF
90 employees
- 63 doctors (24 doctors with an extensive experience in conducting clinical studies),
- 8 nurses and DXA technicians,
- 2 study coordinators,
- 5 assistants,
- 7 secretaries (call-centre, patient registration),
- 6 persons of additional personnel.
TRIALS:
- 83 performed trials,
- 16 ongoing trials, including 4 trials in screening phase.
Osteoporosis trials:
- 3 ongoing osteoporosis trials.
History: 83 performed trials
Diseases: osteoporosis, osteoarthritis, rheumatoid arthritis, menopause, hypertension,
diabetes, ulcerative enteritis, hypercholesterolemia, COPD, asthma, cartilage injury, deepvein thrombosis, acute pain, IBS, chronic constipations, psoriasis, polycystic kidney disease,
migraine, hematology, spondyloarthritis, smoking cessation, high CV risk patients,
onychomycosis.
Company seat
Kopernika 32
31-501 Kraków
Mail building 484 m2
Adjacent buildings 263 m2
Leased:
Hospital wards (planned) 200-600m2
Storage 1,500m2
CLINICAL TRIALS CENTRE
tel. + 4812 423 1722, fax (+) 430 3233
REGISTRATION
tel. +48 12 430 0000
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KRAKOW MEDICAL CENTRE
COOPERATION
Pharmaceutical companies
Abbott Laboratories
ActivX Biosciencies Inc.
Amgen Inc.
Andromeda Biotech Ltd.
Ardea Biosciences, Inc.
AstraZeneca
Aventis Pharma Sp. z o.o.
Baxter Healthcare Corporation
Biotest AG
Boeringer Ingelheim
Coherus Biosciences
CSL Behring GmbH
Daiichi Sankyo
Danone Research
Eli Lilly & Company, Eli Lilly Polska
Ferring International Pharmascience
I.R.I.S.Servier France
Janssen-Cilag Polska
Johnson&Johnson
Kendle
Laboratoires SMB S.A.
Menarini Ricerche S.p.A.
Merck & Co. Inc.
Merck Serono International
Merck Sharp and Dohme Idea
MSD Polska Sp. z o.o.
Novartis Pharma
Organon Polska Sp. z o.o.
Pfizer Inc., Pfizer Polska Sp. z o.o.
Polichem
Procter & Gamble
Proskelia Pharmaceuticals
Rigel Pharmaceuticals Inc.
Servier Polska Sp. z o.o.
Shire plc
Warner Chilcott
CLINICAL TRIALS CENTRE
tel. + 4812 423 1722, fax (+) 430 3233
Clinical Research Organization
CROMSOURCE
Encorium Polska Sp. z o.o.
Grupa Sanofi-Aventis Sp. z o.o.
i3Research
ICON Clinical Research
INC Research
InnoPharma S.r.l.
KCR CRO
Kendle Branches Sp. z o. o.
Medpace Polska Sp. z o.o.
Menarini
MSD Polska Sp. z o.o.
Novartis Pharma Poland Sp. z o.o.
Organon Polska Sp. z o.o.
Orion Clinical Services
Parexel Polska Sp. z o.o.
Pfizer Polska Sp. z o.o.
Pharmaceutical Research Associates Sp. z o.o.
Procter & Gamble Polska Sp. z o.o.
PSI CRO
Quintiles Polska Sp. z o.o.
Roche Holding AG
Sanofi-Aventis SantoSolve A/S
Servier Polska Sp. z o.o.
Smerud Medical Research Poland
Smerud Medical Research Finland
Central and local laboratories
Covance Central Laboratory
ICON Inc Central Laboratories
BARC Bioanalitycal Research Corporation
Esoterix Inc Clinical Trial Services
PPD Global Central Labs
Medpace Reference Laboratories
VirtualScopics Inc
Spranger Laboratories
Synarc
REGISTRATION
tel. +48 12 430 0000
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