The leading event for all parties involved in the clinical trials market in CEE

25 - 26 April 2017

Sponsors

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Synevo
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SanaClis
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Longtaal
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Medicodose
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Vector Logistics
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Infoset
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Spicy Analytics

Associate Partner

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Clinerion

Medical Writing Seminar Partner

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Proper Medical Writing

Media Partners

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Journal for Clinical Studies
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Clinical Informatics News
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PharmaNet.Ua
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European Medical Journal

Synevo Central Labs is the largest wholly-owned, fully-harmonized and GCLP accredited network of central laboratories in Europe dedicated exclusively to support clinical trials. Our facilities in Poland, Romania, Ukraine, Germany, Belarus, Bulgaria, Serbia, Moldova, Georgia, Turkey and in Russia operate with the same analytical platforms, materials and reagents and under identical procedures. We offer a comprehensive organization of a clinical trial laboratory part, starting from study-specific kits preparation and investigator site personnel training through sample logistics management and specimen analyse to lab results reporting and final database transfer. We provide our clients with 24/7 access to a real-time data through our web-based, secured and user-friendly application, known as LabOne.

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SanaClis was founded in 2000 by seasoned industry experts all of whom have had executive level positions in leading pharma companies and large global CROs. SanaClis is a full-service CRO offering a comprehensive range of services for clinical trials in Central and Eastern Europe.

SanaClis is one of the very few CROs offering customs brokerage, warehousing and distribution of clinical trial materials in Ukraine and Russia in its own premises and by own professional staff, in addition to clinical monitoring and regulatory services. SanaClis facilities/depots and processes meet criteria of the most stringent international standards and local requirements.
In 2012, SanaClis s.r.o. was rated positively by reputable business agency Creditreform and for 2013 and 2014 was awarded and certified with the AA rating by Bisnode rating agency. SanaClis has earned its place on Nice Insight's survey of Top Ten lists of Clinical Research Organizations (CROs) for 2015, based on customer perceptions of quality.

This is the first time a Slovakia-based CRO has finished among the leaders in the CRO industry, reflecting intensive investments and quality assurance measures. In 2015, Sanaclis was awarded with the CRO Leadership Award in the category Reliability.

Core products and services:
- Regulatory
- Clinical Monitoring
- IMP & CTS Management
- Customs clearance & brokerage
- Site Contracting & Payments
- Project Management
- Quality Management
- Central Laboratory Russia - incl. Bioequivalence Studies
- Data management, Statistics & Medical writing

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Description: LongTaal provides industry's first class clinical trials intelligence, enabling pharma companies, investigators, regulators, academics and CROs fast access to essential data for trial planning & management. Our clients are thus able to understand sponsors' clinical development strategy, understand the market dynamics in the pharma industry and achieve higher feasibility accuracy. Access www.longtaal.com to request additional information or live demo of our analytics.

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Medicodose Systems specialises in the R&D and commercialisation of innovative patient adherence technologies in a form of smart pharmaceutical packaging and a clinical software suite allowing investigators, CRO & Sponsors real time access to ambulatory clinical human subject adherence data. Thus, accelerating qualitative endpoints that faithfully report how the human subject feels as the trial progresses. Also, besides the process of source data verification that we offer, our innovative technology is a de-facto tool for a successful RBM deployment. We can help a site or a CRO with predictive non-adherence behavior and protocol deviations as they happen and on a continuous basis through out the duration of a trial. Decision can thus be taken on an on-going basis rather than months after the facts. Therefore, the ability to run and manage a centralised and remote monitoring allows investigators, CRAs and other trial staff to perform data checks, review potential inconsistencies while evaluating risk factors and determining and preparing for human-subject site visits only when necessary. The benefits are tenfold through unmatched savings to sites, CROs and Sponsors alike with faster access yet, qualitative, data endpoints.

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Vector Logistics specialises in providing customs representative (broker) services, for Pharmaceutical and Medical spheres, since 1996.


Vector Logistics is one of the pioneer Russian companies which provides Cold Chain logistics services and Customs Clearance Turn Key solutions for Clinical & Pre-Clinical trials, Scientific Researches, Drugs Registrations and Pharmaceutical Expertises.


With over 20 years of experience in organising international and domestic transportations of non-hazardous and hazardous goods with or without temperature control storage conditions, commercial and non- commercial. Wide spectrum of  transportation logistics solutions for both temperature controlled and ambient shipments, warehousing services, documents coordination, licenses and certificates acquiring for import/export purposes.

 

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Infoset provides cloud based clinical trial management solutions allowing pharmaceuticals, CROs and researchers to increase efficiency and quality in clinical research. Infoset aims to bring future possibilities in today’s research even in low budget and complex regulatory environments and has succeeded to replace all paper intensive procedures with intelligent, easy to use electronic workflows. STUDIO is an all-in-one platform for supporting the full cycle of clinical trials gaining cost savings and quicker results to market. Site selection through past and real time metrics, tailor made risk based analytics and monitoring, interactive e-CRF design and EDC, eSource integration, mobile engagement of patient and sites, CDISC models, ePRO and eConsent, are some of the key features of clinical trials evolution.

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Spicy Analytics is a data science one-stop shop for the pharmaceutical and healthcare industry

We provide data technology- and call center-assisted campaign management services from clinical research patient recruitment to patient adherence programs, covering the whole pharmaceutical value chain. Spicy Analytics also help clients improve their operational excellence with IT solutions such as data-based demand forecasting, production planning or capacity and workflow management. Our mission is to combine our vast experience in data mining and software development with our in-depth pharma knowledge to deliver exceptional services to our partners striving to increase their efficiency.

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Clinerion enables early patient access to innovative treatments through solutions for clinical trial patient recruitment, real-world evidence, and market access. Clinerion's Patient Recruitment System accelerates clinical research by radically improving the efficiency and effectiveness of trial recruitment. Key tools for Clinerion’s patient data services include data-assisted protocol optimization, site feasibility evaluation and patient identification. Clinerion’s solutions allow member hospitals to participate in leading-edge, industry-sponsored trials and save time in patient recruitment. They enable pharmaceutical companies to gain time and cost savings by streamlining operations and gaining strategic intelligence. Clinerion’s proprietary Big Data analytics technologies leverage real-time data from electronic health records which remain under the full control of participating hospitals. Clinerion is a global data technology company headquartered in Switzerland. Clinerion's solutions follow international patient privacy and data security standards.

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http://propermedicalwriting.com/

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Hungarian Clinical Trial Management Society (CTMS) is a non-governmental organization of clinical study specialists including most of the hundreds of colleagues working at study sites, pharmaceutical companies, contract research organizations (CROs), academic or regulatory institutions, or private practices.

CTMS was founded in 2001 with the purpose of providing a forum for specialist involved in clinical trials.

By using and sharing the experience accumulated over a decade, it contributes to the professional and ethical standards of clinical studies conducted in Hungary, the legal environment, and human resources to reach a level that globally and regionally increases the competitiveness of Hungary and to live up to the trust of patients who play the most important role in clinical studies.

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The Association of Pharmaceutical Research and Development (APRaD) has been formed by world leading pharmaceutical companies active in the research and development of new medicines that improve health and quality of life, with a presence in Ukraine. As a non-for-profit and non-governmental organization, APRaD gives much emphasis to co-operation with Ukrainian authorities, and other international organizations concerned with health and pharmaceutical industry-related issues.

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Bulgarian Association of Clinical Research (BACR) was registered in 2003 as an independent nongovernmental /not-for-profit/ organization. Up to date the members of BACR are more than 135 persons and legal entities, representatives of such companies as Amgen, Appletree Clinical Investigations, AstraZeneca Bulgaria, August Research, Balkan Trials, Bayer Bulgaria, Biovantix, Clinical Trials Group, Covance, GlaxoSmithKline, INC Research, Institut d'Expertise Clinique - Bulgarie, Janssen, Milray, Novartis Pharma Services, Novo Nordisk Pharma, Patient Recruitment Solutions, PPD Bulgaria, Premier Research, PSI Pharma Support, Quintiles Bulgaria, R&D Services, Resbiomed, Roche Bulgaria, Sanofi-Aventis, Sopharma, Sopharma Trading, Tokuda, World Courier Bulgaria, lawyers, journalists.

 

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LifeScience Klaster Krakow (LSK) is the network of institutions from Krakow and Małopolska Region (Poland) which agreed to collaborate in order to develop and deliver to the market innovations in the field of life sciences.

These organizations represent six areas of interests: biotechnology and life science business, research & development, science and education, healthcare, business support and local government actively guiding and facilitating the cooperation at the regional level.

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www.motesz.hu

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Journal for Clinical Studies (JCS) is a peer reviewed journal which details practical and theoretical operational procedures, challenges, regulatory and submission guidelines when conducting trials on a multisite basis and particularly within emerging markets, naïve patient population and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas. JCS focuses on the ICH - GCP Guidelines globally.

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Part of Cambridge Healthtech Publishing, Clinical Informatics News reports on innovative technologies from clinical trials to medical informatics. Technology continues to permeate all aspects of clinical trials and the patient experience, and the tools to support these efforts are maturing rapidly. ClinicalInformaticsNews.com, the Clinical Informatics News Newsletter and News Bulletins provide authoritative news, views and insights on the vast landscape of innovation between clinical trial management and delivery of care.

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http://pharma.net.ua/

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The European Medical Journal is an independent, open-access eJournal, covering a host of 16 therapeutic areas. They deliver quality peer-reviewed articles along with news coverage from the leading congresses within the medical industry. It aims to deliver ground-breaking advancements in medicine.

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