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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Members

The members of ACTO: Almedis, Bayer, Boehringer Ingelheim, Fortrea, ICON, IQVIA, Janssen Pharmaceutica, KCR, Novartis, Novo Nordisk, Parexel, Pfizer, PPD, PSI, Servier, Worldwide Clinical Trials (WCT).






«ALMEDIS» Ltd.
5, Ulitsa Malaya Pirogovskaya, office 22,
Moscow, Russia
Postal code: 119435
Office phone (+7 495) 937 43 18
Office fax (+7 495) 937 43 19
www.almedis.ru

ALMEDIS is a contract research and consultancy organization, providing comprehensive support to pharmaceutical and biotech companies, academic institutions and contract research organizations.

ALMEDIS provides the full package of services for allocation, management, and execution of clinical trials: medical writing, feasibility assessment, regulatory approval, site monitoring, site management, project management, medical monitoring, data management, statistical analysis, clinical study report.

ALMEDIS services include regulatory affairs, consultancy in the field of medical marketing and quality assurance in clinical studies. ALMEDIS was founded in 2006, Head Office is located in Moscow.




107113 Moscow, Russia
3rd Rybinskaya str., 18, build 2
Phone: +7 495 2311200
Fax: +7 495 2311202
Web: www.bayerpharma.ru

Bayer – is one of the ten largest specialty pharmaceutical companies in the world. The company markets its products in more than 100 countries, and in 2008 generated sales of over ˆ10.7 billion. Approx. 38,000 members of staff currently work for Bayer Schering Pharma worldwide – more than 5,600 in research and development alone.

The 2006 acquisition of Schering was the largest purchase in Bayer’s history. The resulting entity Bayer Schering Pharma, a division of Bayer HealthCare, markedly increases the company’s expertise in the field of pharmaceutical specialties. Combining the expertise of two companies rich in tradition, Bayer Schering Pharma is a leading player both in Germany and in the international arena.

Berlin and Wuppertal in Germany, Berkeley in the United States are the lead research centers in the world.

Manufacturing centers of the company are located in Europe, the United States, Latin America and Asia.

The research and business activities of Bayer Schering Pharma AG are concentrated on four strategic units: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare.

Bayer Schering Pharma aims to improve people’s quality of life with its products. To achieve this, the company concentrates on the research and development of innovative drugs and novel therapeutic approaches. At the same time, Bayer Schering Pharma is constantly improving established products. In this context, Bayer Schering Pharma uses experience it has gained from over a century in the business.
The research and business activities of Bayer Schering Pharma AG are concentrated on four strategic units in which the company makes essential contributions to medical progress:

1. Diagnostic Imaging. Contrast media for the precise and early detection of clinical pictures in CT and MR examinations.
2. General Medicine. Products for high blood pressure, venous thromboembolism, coronary heart diseases, diabetes and infectious diseases, as well as erectile dysfunction and testosterone deficiency in men.
3. Specialty Medicine. Treatment options for multiple sclerosis, hemophilia and certain types of cancer.
4. Women’s Healthcare. Hormonal contraception, menopause management and gynecological therapies.

Business operations in Russia have seen strong growth rates over the past years with the Russian pharmaceutical market being one of the fastest-growing major markets in the world. The potential for industry growth in the Russian pharmaceuticals sector remains considerable, owing to the size of the population and its current low drug-consumption rate.

Along with the growth of business and – since January 2007 – the responsibility for both, former Schering’s and Bayer’s pharmaceutical product portfolio, the number of employees has been risen to more than 500. The product portfolio sold is nearly identical to the Western European one.

Development of Clinical Research – one of the important ways of development of the company in Russia.





Boehringer Ingelheim Pharma GmbH
Leningradskoye shosse, 16A building 3
125171 Moscow
Phone: +7 495 544 50 44
Fax: +7 495 544 56 24

Boehringer Ingelheim is a group of companies dedicated to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. It is one of the world’s 20 leading pharmaceutical companies.

Figures (2009)

  • 142 affiliated companies in 47 countries
  • 41,534 employees
Our corporate vision - "Value through Innovation"

The objectives and beliefs of Boehringer Ingelheim can be summed up in a single phrase: Value through Innovation. This vision has helped us to build on our strengths and make the most of our distinctive character. In a competitive and fast-changing world, the value of products, services and companies is constantly changing. Real customer value today can only be created by constantly developing new solutions and doing what we already do better.

History

Boehringer Ingelheim was founded in Ingelheim am Rhein (Germany) in 1885, where the corporate headquarters is still located.

Business Areas

Human Pharmaceuticals
  • Prescription Medicines
  • Consumer Health Care
  • Industrial Customer
    • Biopharmaceuticals
    • Pharmaceuticals Production
    • Pharma Chemicals
Animal Health

Research & Development

We are spending 21% of net sales in our largest business segment Prescription Medicines (2009) on R&D. We have four main R&D sites and three smaller specialised sites worldwide, which focus on six major therapeutic areas:
  • Respiratory diseases
  • Cardiometabolic diseases
  • Oncology
  • Neurological diseases
  • Immunology
  • Infectious diseases
Uncovering Answers to Protect Patients´ Health

Boehringer Ingelheim has a large and experienced global team managing and conducting clinical trials in many indications. During the past decade from 200 to 2009, Boehringer Ingelheim conducted or sponsored 1,296 studies with 112 substances in 84 countries from all regions of the world.







Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services.

Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.





http://www.iconplc.com/

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We are one of a small group of organisations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis.

We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated "full service" solution.








Moscow office address:

Moscow, 127018, Russia
Dvintsev Street, 12 bld. 1á, floor 4
phone +7 495 721 19 64
fax +7 495 725 10 38

Branch in Saint-Petersburg:

Sredniy Prospect VO, 38, bldg. 1, lit. K
Saint-Petersburg, 199004, Russia
Phone: + 7 812 456 60 78

Branch in Novosibirsk:

Frunze str., 80
Novosibirsk, 630099, Russia
Phone: +7 383 325 01 55



IQVIA (NYSE:IQV) is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients.

Solutions are powered by the IQVIA CORE™, which combines big data, advanced technology, analytics and extensive industry knowledge. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 55,000 employees worldwide. Learn more at www.iqvia.com.








17/2 Krylatskaya str.
121614 Moscow, Russia
Tel.: + 7 (495) 755 83 57
Fax: +7 (495) 755 83 58


Janssen Pharmaceutica N.V.(Belgium) – pharmaceutical company focusing on research and development of new medicines. The company was founded in 1953 by prominent Belgian pharmacologist Paul Janssen and belongs to worldwide renowned international corporation Johnson & Johnson.

Company representative offices are located in more than 40 countries with more than 22,000 employees worldwide.

Janssen Pharmaceutica N.V. is one of the leaders in worldwide pharmaceutical industry. The company developed more than 80 original medicines including Galoperidol, Phentanil, Rispolept, Orungal, Nizoral, Motilium and others.

Main scientific research areas of the company are represented by psychiatry, neurology, oncology, gastroenterology and dermatology.

Antipsychotic drug Rispolept developed by Janssen Pharmaceutica N.V. was honored with international Galen award, which is the highest international award and recognition of outstanding achievement in pharmaceutical industry.

Five medicines developed by Janssen Pharmaceutica N.V. are included in World Health Organization list of vitally important medicines. This is more than any other pharmaceutical company has ever achieved.

Main goal of Janssen Pharmaceutica N.V. is development of new and effective medicines to help patients and improve quality of life. Excellent worldwide reputation of Janssen Pharmaceutica N.V. in medical professional world is constantly maintained by the company’s strict adherence to high quality standards and innovations.








Russia
16 Letnikovskaya Str.,
Business Center “Siberian Alliance”,
115114, Moscow
Tel: +7 495 730 58 30
Fax: +7 495 730 58 31

Germany (HQ)
Pergamon Palais
Am Kupfergraben 4-4a
DE-10117, Berlin
Tel: +49 30 20607975

https://www.kcrcro.com


KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. The company supports clients with full-service capabilities across three main services:

  • Trial Execution (TE)
  • Functional Service Provision (FS)
  • Trial Execution Consulting (TC)

Focusing on knowledge, quality and innovation, KCR offers reliable, customized and fast solutions to fulfill clients' needs in a broad range of therapeutic areas. The company has gathered a wealth of expertise thanks to over 500 studies conducted, more than 5000 investigational sites contracted, and over 50,000 patients recruited.

KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, US, Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com or contact us at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

KCR: We see human behind every number.








Novartis Pharma LLC
Leningradsky ave., 72 bld 3,
125315 Moscow
Russian Federation
Phone: +7 495 6607509
Fax: +7 495 6607510
www.novartis.com

Novartis is recognized as one of the world leaders in pharmaceutical industry.

The Novartis Group of companies offers a wide range of pharmaceuticals to meet the needs of modern healthcare system, including innovative prescription medications (Novartis Pharma), top-quality generics (Sandoz), over-the-counter medicine (Novartis Consumer Health), as well as vaccines and test systems (Novartis Vaccines and Diagnostics).

Novarties Group employs over 100,000 staff and operates in 140 countries worldwide, Russia included, to best meet the needs of the patients.

Novartis production facilities are based in Basel (Switzerland), Grimsby (U.K.), Huningue (France), Kundl and Schaftenau (Austria), Kurtköy (Turkey), Lincoln (NE, United States), Ringaskiddy (Ireland), Singapore, Stein and Schweizerhalle (Switzerland), Suffern (NY, United States).

Novartis major research centers:

  • Novartis Institutes for Biomedical Research (NIBR), Emeryville, East Hanover, Cambridge (MA), Horsham, Basel, Shanghai
  • Novartis Institute for Tropical Diseases (NITD), Singapore
  • Novartis Vaccines Institute for Global Health (NVGH), Siena (Italy)
  • Genomics Institute of the Novartis Research Foundation (GNF), La Jolla (CA)
  • Friedrich Miescher Institute for Biomedical Research (FMI), Basel (Switzerland)
The Group sales in 2009 reached USD 44.3 billion. Novartis has been named the Super Sector Leader among healthcare companies in the 2008 and 2009 updates of the Dow Jones Sustainability Index.

Novartis is rightfully considered to be one of the most rapidly growing companies in healthcare sector and having an extensive portfolio of drugs with valid patents and molecule formulation. Cardiology, metabolism, endocrinology, oncology, neurology, ophthalmology, transplantology, respiratory and infectious diseases comprise the strategic focus of Novartis.

With USD 7.5 billion invested in R&D activities, the Novartis program covers 145 projects aiming both to develop new medications and to improve the existing ones.

Innovation is the underlying principle of the Novartis developments. Novartis was ranked No. 1 by the Fast Company on the biotechnology sector list in 2010. Innovation based on the top-notch level research, ongoing optimization of strategies and processes give serious hope for meeting the most pressing medical needs and improving the quality of life of patients worldwide.






Novo Nordisk LLC
Russia, 119330, Moscow,
Lomonosovsky pr. 38, office 11
Tel: (+7 495) 956-11-32
Fax: (+7 495) 956-50-13
Diabetes Hot Line: 8-800-3333-706
(toll-free in Russia)


Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. Novo Nordisk offers one of the broadest portfolios of diabetes products in the industry, including advanced insulin delivery systems. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 30,900 employees in 76 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).

In Russia, Novo Nordisk products are known for more than 60 years, during which its standards of quality and efficiency have been recognized by local healthcare professionals and patients. Novo Nordisk representative office was opened in Russia in 1991, and today it employs more than 200 employees working in all regions of the country. The priority for Novo Nordisk in Russia is to increase the accessibility of innovative diabetes treatment for Russian patients. For this purpose the company is investing into the modern insulin plant in the Kaluga region.

In order to contribute to the development of the healthcare system in Russia, and strengthen the nation’s health, Novo Nordisk is also conducting broad outreach, educational and humanitarian campaigns.

For more information, visit novonordisk.ru.







PAREXEL International (RUS) LLC
23 Osenny bulvar
Moscow 121609
Russia
Tel. +7 495 781 39 09
Fax. +7 495 781 39 29
Web-site: http://www.parexel.com


PAREXEL is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do.





Pfizer H.C.P. Corporation
10 Presnenskaya emb.,
123317, Moscow, Russia
BC "Naberezhnaya tower" (Block Ñ)
Ph: +7 495 287 50 00
Fax: +7 495 287 50 89


Pfizer is the leading pharmaceutical company in the world dedicated to developing new, safe medicines to prevent and treat the world's most serious diseases.

Pfizer was founded in 1849 in New York and now works in more than 150 countries. Pfizer R&D centers are in Great Britain and the USA. Pfizer has been working in Russia since 1992.

Pfizer has the largest pipeline in the pharmaceutical industry and annually invests more than $7 billion in research and new drugs development.







214020 Smolensk
Shevchenko Street, 65B

Tel. (+7 4812) 207 500
Fax (+7 4812) 207 600


PPD, is a leading global contract research organization, celebrating 25 years of providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 42 countries and more than 11,000 professionals worldwide, PPDs Russian offices are located in Smolensk, Moscow, St. Petersburg and Novosibirsk, employing more than 210 employees. PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

Discovery Services:

  • BioDuro, A PPD® Company
    • A drug discovery services company focused on integrated drug discovery programs
  • Nonclinical development
  • Preclinical services

Clinical Development Services:

  • Phase I clinic
  • Phase II-IIIb trial management and monitoring
  • Bioanalytical labs
  • Biomarker services
  • Biostatistics and programming
  • cGMP labs
  • Clinical supplies
  • Data management, including EDC
  • Device development services
  • Global central labs
  • Interactive voice response systems
  • Medical information
  • Medical writing
  • Pharmacovigilance
  • Product development
  • Program management
  • Regulatory management and dossier submissions
  • Site and patient recruitment
  • Vaccines and biologics lab

Post-approval services

  • Late stage research
    • Epidemiology: pharmacoepidemiology and health outcomes
    • Observational studies
    • Phase IIIb-IV trials
    • Registries
    • Risk management, REMS
    • Safety surveillance studies
  • Medical communications






Russia
19/21 Dostoyevsky Street
191119 St. Petersburg
Tel: +7 812 320 3820
Fax: +7 812 320 3850

USA
203 Redwood Shores Parkway,
Suite 210
Redwood City, CA 94065
Tel: +1 650 592 9101
Fax: +1 650 592 9109


PSI is a leading full-service CRO with 700+ full-time staff across Europe and North America.

PSI has always been distinguished by exceptionally strong presence in Central and Eastern Europe - the region that has over the years become a major provider of clinical trial data for international drug development sponsors.

The largest office and the operational headquarters are in St. Petersburg, Russia (450 people). From St. Petersburg - beginning in 1995 - the Company has grown organically to offices in Russia, Ukraine, Romania, Bulgaria, Poland, Estonia, Czech Republic, Switzerland and the USA. In the US, PSI has an operational office in Philadelphia and a business development office in San Francisco. The mother company, PSI CRO AG, is in Zug, Switzerland. In Western Europe, PSI’s operational presence stretches out to Germany, Austria, France, Hungary and the Baltic countries. PSI is privately owned. For more information go to www.psi-cro.com







Les Laboratoires Servier
7, Lesnaya str.
125196, Moscow, Russia

Tel.: (+7 495) 937 07 00
Fax: (+7 495) 937 07 01

www.servier.com

The French Pharmaceutical Group SERVIER was founded in 1954 by Doctor Jacques Servier. Doctor Jacques Servier is the President of the Group.

The French Pharmaceutical Group SERVIER is today one of the most actively developing and quickly growing pharmaceutical companies in the world as well as in Russia. During 30 years the company registered more than 30 original medicines.

SERVIER’s worldwide workforce is over 20 000 including nearly 3 000 in Research and Development.

Every year more than 25% of SERVIER’s turnover is invested in Research and Development.

SERVIER’s medicines are now presented in 140 countries of the world.

SERVIER was established in Russia in 1992. Due to permanent investments and strict observance of the strategy based on ethics and scientific investigations SERVIER became one of the leaders of the pharmaceutical market. Medicines for treatment of cardiovascular system, diabetes, central nervous system, respiratory diseases, oncology diseases and other are presented in Russia.

SERVIER is well known by its cooperation with Russian scientific societies and associations in the field of organization of educational programs, ìedical congresses, scientific studies which are directed to the development of Russian health care system, scientific knowledge diffusion among medical doctors and development of medical information awareness of patients, specifically, in cardiovascular diseases, respiratory diseases, diabetes and other.

 







Worldwide Clinical Trials (WCT) is a leading provider of international contract clinical research services, focusing on early and late-stage drug development services for pharmaceutical and biotechnology companies. We develop sophisticated and innovative approaches to research, with primary focus in the areas of cardiovascular and central nervous system medicine, along with significant experience in Chronic Inflammatory Disease, Metabolic / Endocrinology and Oncology.
In 2008 the Evidence Company became the integral part of the WCT organization.


Corporate Headquarters/Americas

401 North Maple Drive
Beverly Hills, CA 90210
Tel: (310) 786-9100
Fax: (310) 786-9101
Central / Eastern Europe & Russia

64V, Malookhtinsky pr., 26N, 27N,
St.Petersburg, 195112,
Russia
Tel: 7 (812) 346 8247
Fax: 7 (812) 346 8248
Europe

1st Floor, Waterfront House,
Business Park,
Beeston, Nottingham, NG9 1LA,
UK
Tel: 44 (0) 115 951 7100





 
   
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