Global fully-integrated scientific and clinical research services to address new health benefit needs.

Transcription

1 Global fully-integrated scientific and clinical research services to address new health benefit needs. A SPRIM HEALTH GROUP COMPANY

2 We believe in primary prevention.

3 Sprim Advanced Life Sciences: a unique and specialized Contract Research Organization Recently it has become increasingly evident for the biopharmaceutical and healthcare companies the need of a support in order to succeed in the current extremely competitive marketplace and to ensure a successful lunch of a product in the market. New studies need to meet the scientific standards of experimental design, operative issues, data analysis and quality assurance to be useful for partner companies. In this rapidly changing environment, SPRIM ADVANCED LIFE SCIENCES leads the way to achieve strategic collaborations with companies delivering a fully-integrated complete range of services responding to all the customers needs at every stage, from early development to post-marketing research programs, providing with the most comprehensive approach to scientific evidence development. SPRIM ADVANCED LIFE SCIENCES is a global clinical research organization focused on human health and health preservation, with a reality based clinical program and a creative attitude towards strategic issues aimed to improve quality and convenience of clinical trials. 3

4 What we Believe We work for helping companies in building up scientific and clinical projects to identify ways of improving life conditions: Quality of Life Improvement Ameliorating the general quality of life of people Body Empowerment Improving the body status in order to reach better physical performances Lifestyle Physiological Performance Prevention Personalized Efficacy Health Preservation Preventing people from avoidable pathological conditions through Treatments Optimization Optimizing treatments and enhancing the practice of personalized medicine among people 4

5 Our target is Health...Globally We provide support to departments and research teams worldwide to optimize and expedite their current and future research strategies. Global reach (15 countries, 20 offices) Multi-disciplinarity A global scientific network of Investigators, KOLs and resources (more than 400 contracted Investigators worldwide) Focused on Scientific, Regulatory and Market relevant endpoints In-house expertise key facts Long-standing relationships with industry (over 400 clients globally) Rapid Recruitment Units (over 60 contracts with hospitals, private institutions, universities, schools, elderly communities) With SPRIM ADVANCED LIFE SCIENCES, a new model of CRO has risen to handle the new demands of industries and companies. We consider Human Health as a value creation driver for mankind: Food and Consumer Goods Industry Biopharmaceutical Industries Scientific Community Global and Local Markets We draw on proven expertise and multiple resources to build a customized solution for each client s specific business challenge. As the needs of our clients evolve, SPRIM ADVANCED LIFE SCIENCES keeps on developing new partnerships and resources in order to reach the best possible efficiency in each scientific area and across each market. 5

6 Our Solutions SPRIM ADVANCED LIFE SCIENCES, thanks to its network of investigational, sites laboratories, and offices, may support clients in the performance of different scientific programs, including: Preclinical studies in different animal models; Interventional trials (Phase I, II, III); Post-approval and Phase IV studies; Observational studies; Quality of life studies; Safety and toxicology studies; Medical Devices validation studies; Consumer s testing studies; Post-marketing and regulatory commitments; Comparative Effectiveness research studies; Quality measurement and improvement studies; Benefit-Risk management trials; Medical scienitif actiuty Ckinical consumer research We offer a wide network of more than 500 experienced professionals all over Europe, Americas and Asia, associated with partners in order to give direct assess to research activities in the world s key markets with continuous high standard of quality and following GCPs. 6

7 The right Solution for Client Needs SPRIM ADVANCED LIFE SCIENCES offers a fullservice solution for clients projects, providing a dedicated team in the clinical research area. We offer a full range of services required for the successful clinical development of new compounds, ingredients, medical devices food and nutraceuticals, from single studies to complete development programs. Every project is assured with our complete focus and is conducted to the highest level of regulatory standards, because we believe in managing our client relationships as strong as we manage our studies. We are focused on making every global study efficient and convenient in terms of costs and time, working to rapidly solve the most critical challenges of clinical research, such as patients recruitment, and site management logistics, the greatest obstacles in clinical trials today. SPRIM ADVANCED LIFE SCIENCES assists clients in getting the right sample for each trial, applying creative recruitment strategies and prioritizing trial sites, in order to achieve the best results in a timely manner. Our clinical platform has access to updated databases including diseased / sub-healthy / healthy populations, in order to meet each product s characteristics to be assessed. Gynecology / Urology Sport Nutrition Oral Care Immunology/ Opthalmology Pediatrics Endocrinology Allergology Gastro - Enterology Skin Health/ Dermatology Bone Health Nutrition/ Cardiology Cognitive Science Healthyaging Weight Management 7

8 An innovative Point of View SPRIM ADVANCED LIFE SCIENCES holds a deep expertise in many medical branches and scientific fields, focused in an extremely different manner, in comparison with traditional Clinical Research Organizations. SPRIM ADVANCED LIFE SCIENCES develops science basing on Reality, finding the right approach to meet the requirements of the scientific community, working around client s needs with Passion and Dedication and supporting our partner companies in each stage of the product development, from small studies to complex, international projects, being responsive and providing customized services in order to support both locally and globally managed projects. An Expert Team Project Management and Start-up Monitoring Data Management and Biometrics Medical Writing Regulatory Issues Management 8

9 Key facts Project Management and Start-up Efficient planning and monitoring of clinical research projects is a critical point of products lifecycle. With our extensive clinical development experience, we are able to offer to our clients appropriate allocation of resources and innovative strategies and tools bringing commercial insights into clinical development, resulting in more efficient studies meeting clients needs and providing higher quality data to help improve products success in the marketplace. We understand that every study is different, and our dedicated operational experts can help design the right operational strategy to fulfill the unique objectives of clients programs. Monitoring We offer a wide network of more than 50 experienced monitors all over Europe, North & South America and Asia, meeting today s requirements for global development programs. We place the highest importance on delivering quality data on time and on budget: from start-up to completion, performance is monitored regularly and measured against contractual timelines, in order to maintain continuous high standards of quality and GCPs. Data Management and Biometrics The systematic growth of clinical data from health information systems promises to provide more timely and accurate information to help answer questions on effectiveness, safety and quality of healthcare. Through a series of partnerships and networks, SPRIM ADVANCED LIFE SCIENCES delivers highquality, cost-effective solutions to ensure a successful management and delivery of clinical trial data and timely analysis and reporting of study results. Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project and to offer a full range of EDC services, that can be combined to meet virtually any need. We have extensive knowledge of experimental design and statistical methodology, therefore enabling us to give advice on all aspects of design, sizing and conduct of a study in order to ensure that all design and analysis methods fully conform to the latest standards and guidelines. case study Multi-centric clinical trial on the effects of a probiotic mixture on Atopic Dermatitis Symptoms in children Subjects = 126 Country = Spain case study Multi-centric, cross-country clinical trial on the effects of egg-derived proteins on age-related macular degeneration in adults Subjects = 120 Countries = DE, UK, US 9

10 Regulatory Issues Management Diligent study planning facilitates smooth and speedy approval procedures by IRBs / ECs and regulatory authorities. SPRIM ADVANCED LIFE SCIENCES regulatory department offers support in start-up activities, applications to Ethic Commitees and Competent Authorities according to international and national guidelines and ensures the regulatory compliance through a dedicated approach. Our advisory regulatory service provides clients with the full range of regulatory services covering all stages of product development. case study case study Medical Writing Understanding the keys making each therapeutic and medical scientific area unique, combined with a deep scientific and clinical knowledge in that area can lead to better study outcomes for innovative products. Our expertise in all major medical areas can provide valuable insight and support from the protocol design to site recruitment and retention to analyzing and publishing comprehensive and meaningful results. Our medical writing team consists in more than 30 English and other native speakers, all of whom are highly qualified in either medicine or life sciences with many years of experience, making us a reliable and valuable support for clients scientific needs. Multi-centric, 3-arm parallel twin clinical trials on the effects of milk-based formulas on infections and immune functions in healthy children Subjects = 930 Countries = RI, MEX Quality Management Multi-centric, crosscountry clinical trial on the effects of prebiotic fiber on functional constipation in children Subjects = 184 Country = ITA, US An internal quality assurance system to ensure that all studies are ICH/GCP and GMP compliant and follow applicable Standard Operating Procedures (SOPs), or Quality System Procedures (QSPs). Our Quality Management department issues a Quality Management Plan for each new study, which outlines the quality procedures that have to be implemented during the clinical trial, including regular scheduled audits and spot checks for the study. 10

11 SPRIM MEXICO SPRIM USA SPRIM UK London SPRIM SPAIN Madrid SPRIM BRAZIL Dublin SPRIM FRANCE Paris Porto Lisbon Glasgow Edinburgh Sevilla Liverpool Manchester Bordeaux Amsterdam Kiev Rotterdam Hamburg Berlin Poznan Warsaw Bruxelles Frankfurt Munich Prague Krakow Geneva Zurich Wien Lyon Budapest Turin Zagreb Bucharest Marseille Bologna Rome Barcelona Naples Valencia Oslo Copenhagen SPRIM GCP Milan Stockholm Helsinki Minsk Moscow Athens Donetsk SPRIM CHINA SPRIM INDIA SPRIM INDONESIA SPRIM JAPAN SPRIM THAILAND SPRIM SINGAPORE SPRIM ARGENTINA SPRIM AUSTRALIA EUROPE: GLOBAL CLINICAL PLATFORM Via Brisa, Milano Tel: SPAIN C/Hermosilla, Madrid Tel: REGIONAL OFFICES: USA, MEXICO, BRAZIL, ARGENTINA, JAPAN, CHINA, INDIA, THAILAND, SINGAPORE, INDONESIA, AUSTRALIA. AD HOC CLINICAL UNITS: UK: (London, Glasgow, Edinburgh, Liverpool, Manchester) IRELAND: (Dublin) SPAIN: (Madrid, Sevilla, Valencia, Barcelona) PORTUGAL: (Porto, Lisbon) FRANCE: (Bordeaux, Paris, Lyon, Marseille) SWITZERLAND: (Geneva, Zurich) BELGIUM: (Bruxelles) GERMANY Charlonttenstr, Berlin Tel: +49 (0) FRANCE 27, Avenue de l Opèra Paris Tel: NETHERLANDS: (Amsterdam, Rotterdam) ITALY: (Milan, Bologna, Rome, Naples) GERMANY: (Berlin, Hamburg, Frankfurt, Munich) AUSTRIA: (Wien) CZECH REPUBLIC: (Prague) POLAN: (Poznan, Warsaw, Krakow) HUNGARY: (Budapest) CROATIA: (Zagreb) UK 16, Beaufort Court Admirals Way E14 9XL Docklands, London Tel: ITALIA Via Brisa, Milano Tel: GREECE: (Athens) ROMANIA: (Bucharest) UKRAINE: (Kiev, Donetsk) BELARUS: (Minsk) RUSSIA: (Moscow) FINLAND: (Helsinki) SWEDEN: (Stockholm) NORWAY: (Olso) 11

12 We build scientific evidence starting from new consumer needs. Join us at: