clinical research center sp. z o.o

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CURRENTLY WE CONDUCT CLINICAL STUDIES IN THE FOLLOWING INDICATIONS:

• Episodic childhood migraine
• Chronic childhood migraine
• Post-polio syndrome
• Bladder cancer
• Ulcerative colitis
• Crohn's disease
• Study to evaluate the effect of evolocumab on the reduction of cardiovascular events in a patient population at high cardiovascular risk
• Hot flashes in women during menopause
• Prostate cancer
• Primary progressive multiple sclerosis
• Overactive bladder

IN THE NEAR FUTURE WE PLAN TO START TRIALS WITH NEW DRUGS FOR:

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• Free access to the latest treatments and new drugs
• The highest standards of medical care
• Free laboratory testing and medical diagnostics
• Constant attendance by the investigator (medical specialist)

CONTACT US:

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CLINICAL RESEARCH CENTER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Badania Kliniczne

Pokrzywka idiopatyczna, pęcherz nadreaktywny, uderzenia gorąca u kobiet w okresie menopauzy, spastyczność kończyn, migrena dziecięca przewlekła, rak pęcherza moczowego, migrena dziecięca epizodyczna, toczeń układowy, rak prostaty, zespół post-polio, migrena dorosłych, wrzodziejące zapalenie jelita grubego, atopowe zapalenie skóry, ból w endometriozie, przewlekły wyprysk rąk.

• psychiatrii
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• dermatologii
• kardiologii
• reumatologii
• ginekologii
• hematologii

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GET INSPIRED

Transform your clinical studies with us, search solutions. find experts., clinical research committed to you.

MONIPOL is a fast-growing European CRO with local offices in Germany, Poland, and Switzerland and 25+ years of proven track record in various therapeutic areas. MONIPOL offers a complete range of clinical development and consulting services to a strong customer base of primarily small and mid-size pharmaceutical, biotechnology, and medical device companies.

Our work in numbers

MONIPOL has a solid track record since 1995

Why to choose MONIPOL?

• Client First. Always.
• Proven track record since 1995
• Delivery on Time. On Budget.
• Robust footprint across Europe
• Superior patient recruiting
• Next Generation CRO

Find a Solution Tailored to You

We are not ordinary. Rather we aspire to be a Next Generation CRO. We provide insight-based solutions along the value chain customized to your specific needs.

Find Specialists

Get to know our team of experienced professionals and learn about their backgrounds. We share inclusivity and open exchange as core values in our daily interactions with clients and colleagues alike.

Jumpstart Your Career

We are hiring! Up for the challenge? At MONIPOL you have your own projects and responsibilities from day one. We facilitate an environment for professional and personal growth.

EMAIL US [email protected] [email protected]

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CALL US DE +49 228 2278 7800 PL +48 12 6301850 (Mon-Fri 8:00-17:00 CET)

MTZ CLINICAL RESEARCH

Clinical Research Center MTZ Clinical Research powered by Pratia ul. Gladka 22 02-172 Warsaw, Poland ......... Pratia Spółka Akcyjna ul. Gladka 22 02-172 Warsaw, Poland Business Register Nº 00428924 VAT Nº PL 118-208-61-13

CLINICAL RESEARCH OPERATION SERVICES

Sites and Investigators Network was developed to have a unique approach for feasibility and site selection process both on the country and site level. We know that every Sponsor demands accelerated timelines, measurable results, and reliable data.

CLINICAL DEVELOPMENT SOLUTIONS

Project management.

• Project set up and Delivery from Feasibility to Close out visit
• Risk Management
• Vendor Management
• Project coordination

CLINICAL MONITORING

Patients’ recruitment.

• Study sites coordination
• Site recruitment
• Cooperation with recruitment companies
• Retention Plans

Our experience and cooperation with physicians, clinics and societies makes us a unique full service CRO.

THERAPEUTIC AREAS

Our fields of work:.

• Endocrinology
• Dermatology
• Orthopaedics
• Rheumatology
• Healthy patients
• Women’s health
• Infection disease

OUR PARTNERS

Study record managers: refer to the Data Element Definitions if submitting registration or results information.

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Multicenter Registry on Robotically Assisted PCI - TESLA (TESLA)

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R-PCI represents a novel approach to performing PCI with several studies showing high technical success and low complication rates. The CorPath GRX System is the second generation of the CorPath platform, dedicated to advancing robotic-assisted vascular procedures to mitigate the orthopaedic and radiation-related occupational hazards associated with the practice of interventional cardiology.

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Siemens Healthineers, Germany) in real-world interventional cardiology practice in Europe and Asia.

All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System and completed one-year follow-up are eligible for recruitment in this registry, if older than 18 years. This study includes patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

The Study Investigators expect to enroll at least 700 patients (up to 1000). International centers that performed R-PCI with the CorPath GRX System will be invited to participate in this multicenter study.

Baseline, procedural, and follow-up data will be collected for all cases.

Inclusion Criteria:

• Older than 18 years,
• Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI),
• Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.

Exclusion Criteria:

- Unwillingness to provide informed consent (only if applicable).

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PRO PACIENTY

PRO LÉKAŘE A LÉKAŘSKÁ ZAŘÍZENÍ

PRO ZADAVATELE KLINICKÝCH STUDÍ

Jsme první síť center klinických studií v České republice a na Slovensku.

Proč děláme to, co děláme.

Našim lékařům a zadavatelům klinických studií nabízíme službu, která mění pohled na testování léčiv v České republice a na Slovensku, zejména v ambulantní péči a umožnuje účast na klinických studiích většímu počtu lékařů a pacientů, při naplnění požadavků kvality a bezpečnosti.

JAK toho dosahujeme?

Naše znalosti a aktivní zapojení do průběhu studie přímo v lékařské ordinaci umožňují širšímu počtu lékařů různých specializací účastnit se klinických studií. Odstraňujeme bariéry a minimalizujeme administrativní zátěž kladenou na lékaře a jeho tým při výkonu klinických studií. Zvyšujeme tím kapacitu lékařského centra, kvalitu a včasnost předání dat. Pro pacienta se komunikace stává jednodušší a jeho dotazy jsou zodpovězeny prakticky ihned. Inovujeme a umíme řídit změny. Naše interní procesy se snažíme standardizovat, automatizovat a digitalizovat.

Zefektivňujeme proces vývoje a testování účinnějších léků či medicínských nástrojů při maximální bezpečnosti pacienta v lékařských centrech sítě Clinical Research Center s.r.o.

Od roku 2016 budujeme tým profesionálních a vyškolených koordinátorů klinických studií , kteří svými službami a znalostmi zvyšují efektivitu práce lékařů i komfort pacientů. Vytváříme a spravujeme síť vybraných lékařů z různých oblastí medicíny za účelem kvalitního zpracování a provedení klinických studií.

Spolupráce centra klinické studie a profesionálního a vyškoleného koordinátora má mnoho pozitivních přínosů pro lékaře, subjekt i zadavatele klinického hodnocení. Společně pracujeme efektivněji. Zvyšujeme povědomí o klinických studiích, testování nových léků a nových léčebných metodách. Zodpovídáme dotazy lékařů i potenciálních pacientů. Informujeme veřejnost o studiích s  probíhajícím náborem pacientů .

V roce 2020 jsme založili společnost CRC Home Care zaměřenou na organizaci domácích pacientských návštěv v rámci klinických studií.

Mgr. Lucie Špatenková Managing Director

Jsme registrovaným členem SCRS (Society for Clinical Research Sites), účastníme se mezinárodních kongresů a neustále se vzděláváme. Inovujeme a zlepšujeme naše procesy.

V rámci certifikačního auditu v roce 2022 bylo společností Alcumus ISOQAR konstatováno splnění požadavků výše uvedené normy ISO9001:2015 jak v České republice tak na Slovensku.

Clinical Research Center je dodavatelem v oblasti klinických studií pro Karlovu Univerzitu.

  Clinical Research Center bylo vybrán jak vítěz ceny European Site Spark 2022 , která se uděluje za vynikající a inovativní práci výzkumných pracovišť, která zavádějí nové a zajímavé způsoby provozování studií. Více zde..

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Locations / Contact

Headquarter

FGK Clinical Research GmbH Heimeranstrasse 35 80339 Munich, Germany + 49 (0) 89 893 119-0 + 49 (0) 89 893 119-20 www.fgk-cro.com info @ fgk-cro . com

Martin Krauss, M.Sc. in Statistics + 49 (0) 89 893 119-25 + 49 (0) 173-581 4683 martin.krauss @ fgk-cro . com

Edgar J. Fenzl, M.D. Ph.D. + 49 (0) 89 893 119-22 + 49 (0) 172-673 8556 edgar.fenzl @ fgk-cro . com

Branch Office Berlin

The Berlin office supports the operative units at the German headquarters in Munich by strengthening the range of clinical development services. The core expertise of the highly qualified lead/staff/employees in Berlin lies in project and site management, monitoring and quality management of phase II-IV clinical trials.

FGK Clinical Research GmbH Friedrichstraße 95 10117 Berlin Germany www.fgk-cro.com info @ fgk-cro . com

Hermine Wenzlaff Prof. Dr. +49 (0) 30 235 9183 – 10 +49 (0) 175 194 07 26 hermine.wenzlaff @ fgk-cro . com

Czech Republic

FGK Clinical Research s.r.o. is a contract research organization and provides a wide range of services in drug and medical device development. The core competences of FGK Clinical Research s.r.o. are regulatory affairs, project management and monitoring of phase II-IV trials in the Czech Republic and Slovakia.

FGK Clinical Research s.r.o. Polská 1283/18 120 00 Prague 2 Czech Republic info @ fgk-cro . cz

FGK Clinical Research sp. z o.o. is a contract research organization specializing in providing high-quality expertise in local regulatory affairs, project management and monitoring in Poland. FGK Clinical Research sp. z o.o. is a significant addition to the European FGK Clinical Research group, allowing the company to enhance the range of clinical development services for national and international clinical studies.

FGK Clinical Research sp. z o.o. Hoża 55 m.45 00-681 Warsaw Poland info @ fgk-cro . pl

FGK Clinical Research Kft. is a contract research organization specializing in providing high-quality expertise in local regulatory affairs, project management and monitoring in Hungary. FGK Clinical Research Kft. is a significant addition to the European FGK network, allowing the company to enhance the range of clinical development services for national and international clinical studies.

FGK Clinical Research Kft. Tölgyfa u. 14 1027 Budapest Hungary info @ fgk-cro . hu

United Kingdom

Clinicology Ltd. became an FGK company in February 2024 and covers the UK with offices in Guildford, UK. The company provides high quality clinical trial services and has outstanding expertise in local regulatory affairs and trial conduct.

Clinicology – an FGK company Surrey Technology Centre 40 Occam Road Surrey Research Park Guildford GU2 7YG UK info @ fgk-cro . com

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The Unique Burial of a Child of Early Scythian Time at the Cemetery of Saryg-Bulun (Tuva)

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Pages:  379-406

In 1988, the Tuvan Archaeological Expedition (led by M. E. Kilunovskaya and V. A. Semenov) discovered a unique burial of the early Iron Age at Saryg-Bulun in Central Tuva. There are two burial mounds of the Aldy-Bel culture dated by 7th century BC. Within the barrows, which adjoined one another, forming a figure-of-eight, there were discovered 7 burials, from which a representative collection of artifacts was recovered. Burial 5 was the most unique, it was found in a coffin made of a larch trunk, with a tightly closed lid. Due to the preservative properties of larch and lack of air access, the coffin contained a well-preserved mummy of a child with an accompanying set of grave goods. The interred individual retained the skin on his face and had a leather headdress painted with red pigment and a coat, sewn from jerboa fur. The coat was belted with a leather belt with bronze ornaments and buckles. Besides that, a leather quiver with arrows with the shafts decorated with painted ornaments, fully preserved battle pick and a bow were buried in the coffin. Unexpectedly, the full-genomic analysis, showed that the individual was female. This fact opens a new aspect in the study of the social history of the Scythian society and perhaps brings us back to the myth of the Amazons, discussed by Herodotus. Of course, this discovery is unique in its preservation for the Scythian culture of Tuva and requires careful study and conservation.

Keywords: Tuva, Early Iron Age, early Scythian period, Aldy-Bel culture, barrow, burial in the coffin, mummy, full genome sequencing, aDNA

Information about authors: Marina Kilunovskaya (Saint Petersburg, Russian Federation). Candidate of Historical Sciences. Institute for the History of Material Culture of the Russian Academy of Sciences. Dvortsovaya Emb., 18, Saint Petersburg, 191186, Russian Federation E-mail: [email protected] Vladimir Semenov (Saint Petersburg, Russian Federation). Candidate of Historical Sciences. Institute for the History of Material Culture of the Russian Academy of Sciences. Dvortsovaya Emb., 18, Saint Petersburg, 191186, Russian Federation E-mail: [email protected] Varvara Busova  (Moscow, Russian Federation).  (Saint Petersburg, Russian Federation). Institute for the History of Material Culture of the Russian Academy of Sciences.  Dvortsovaya Emb., 18, Saint Petersburg, 191186, Russian Federation E-mail:  [email protected] Kharis Mustafin  (Moscow, Russian Federation). Candidate of Technical Sciences. Moscow Institute of Physics and Technology.  Institutsky Lane, 9, Dolgoprudny, 141701, Moscow Oblast, Russian Federation E-mail:  [email protected] Irina Alborova  (Moscow, Russian Federation). Candidate of Biological Sciences. Moscow Institute of Physics and Technology.  Institutsky Lane, 9, Dolgoprudny, 141701, Moscow Oblast, Russian Federation E-mail:  [email protected] Alina Matzvai  (Moscow, Russian Federation). Moscow Institute of Physics and Technology.  Institutsky Lane, 9, Dolgoprudny, 141701, Moscow Oblast, Russian Federation E-mail:  [email protected]

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Out of the Centre

Savvino-storozhevsky monastery and museum.

Zvenigorod's most famous sight is the Savvino-Storozhevsky Monastery, which was founded in 1398 by the monk Savva from the Troitse-Sergieva Lavra, at the invitation and with the support of Prince Yury Dmitrievich of Zvenigorod. Savva was later canonised as St Sabbas (Savva) of Storozhev. The monastery late flourished under the reign of Tsar Alexis, who chose the monastery as his family church and often went on pilgrimage there and made lots of donations to it. Most of the monastery’s buildings date from this time. The monastery is heavily fortified with thick walls and six towers, the most impressive of which is the Krasny Tower which also serves as the eastern entrance. The monastery was closed in 1918 and only reopened in 1995. In 1998 Patriarch Alexius II took part in a service to return the relics of St Sabbas to the monastery. Today the monastery has the status of a stauropegic monastery, which is second in status to a lavra. In addition to being a working monastery, it also holds the Zvenigorod Historical, Architectural and Art Museum.

Belfry and Neighbouring Churches

Located near the main entrance is the monastery's belfry which is perhaps the calling card of the monastery due to its uniqueness. It was built in the 1650s and the St Sergius of Radonezh’s Church was opened on the middle tier in the mid-17th century, although it was originally dedicated to the Trinity. The belfry's 35-tonne Great Bladgovestny Bell fell in 1941 and was only restored and returned in 2003. Attached to the belfry is a large refectory and the Transfiguration Church, both of which were built on the orders of Tsar Alexis in the 1650s.  

To the left of the belfry is another, smaller, refectory which is attached to the Trinity Gate-Church, which was also constructed in the 1650s on the orders of Tsar Alexis who made it his own family church. The church is elaborately decorated with colourful trims and underneath the archway is a beautiful 19th century fresco.

Nativity of Virgin Mary Cathedral

The Nativity of Virgin Mary Cathedral is the oldest building in the monastery and among the oldest buildings in the Moscow Region. It was built between 1404 and 1405 during the lifetime of St Sabbas and using the funds of Prince Yury of Zvenigorod. The white-stone cathedral is a standard four-pillar design with a single golden dome. After the death of St Sabbas he was interred in the cathedral and a new altar dedicated to him was added.

Under the reign of Tsar Alexis the cathedral was decorated with frescoes by Stepan Ryazanets, some of which remain today. Tsar Alexis also presented the cathedral with a five-tier iconostasis, the top row of icons have been preserved.

Tsaritsa's Chambers

The Nativity of Virgin Mary Cathedral is located between the Tsaritsa's Chambers of the left and the Palace of Tsar Alexis on the right. The Tsaritsa's Chambers were built in the mid-17th century for the wife of Tsar Alexey - Tsaritsa Maria Ilinichna Miloskavskaya. The design of the building is influenced by the ancient Russian architectural style. Is prettier than the Tsar's chambers opposite, being red in colour with elaborately decorated window frames and entrance.

At present the Tsaritsa's Chambers houses the Zvenigorod Historical, Architectural and Art Museum. Among its displays is an accurate recreation of the interior of a noble lady's chambers including furniture, decorations and a decorated tiled oven, and an exhibition on the history of Zvenigorod and the monastery.

Palace of Tsar Alexis

The Palace of Tsar Alexis was built in the 1650s and is now one of the best surviving examples of non-religious architecture of that era. It was built especially for Tsar Alexis who often visited the monastery on religious pilgrimages. Its most striking feature is its pretty row of nine chimney spouts which resemble towers.

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