Conference:
Pre-conference workshop
1 Dec 9am - 5pm
Day 1
2 Dec 8.30am - 5:30pm
Day 2
3 Dec 8.30am - 5:30pm
Post-conference workshop
4 Dec 8.30am - 5:30pm
Venue:
The Bloomsbury Hotel, London, United Kingdom
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Meet our sponsors...
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PRA International
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 PRA’s Late Phase Services group supports global and regional Post-Approval studies. Our highly-experienced team assists sponsors with the Post-Marketing process by planning and conducting Post-Authorisation Safety Studies/Safety-Surveillance Studies, Drug Utilisation Studies, Large Simple Trials (LSTs), Registries, Restricted Access Programs and Risk Management Programs. With many years experience managing late phase studies ranging in size from 60 to 18,000 patients in over 40 countries, our international management team leads a truly global late phase team with centralized locations in Horsham, PA, USA and Mannheim, Germany. PRA supports our Late Phase Services operational team with industry-leading strategic, scientific, medical, and epidemiological experts.
PRA International is a global Clinical Research Organization providing services through all phases of clinical development. We specialize in oncology, CNS, respiratory/allergy, cardiovascular and infectious diseases. PRA has supported over 2,100 clinical trials in more than 65 countries on 6 continents through our global offices.
www.praintl.com
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Quintiles
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 Quintiles is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the lifesciences industries. With 20,000 employees and offices in more than 50 countries, Quintiles is the leading provider of clinical services from Phase I through post-marketing. We have a dedicated Late Phase group that provides innovative, tailored solutions to your post-marketing needs, whether your goal is expanding your product label, demonstrating product value or monitoring safety.
www.quintiles.com
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i3 Innovus
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i3 Innovus is a world leader in health economics, outcomes, and late phase research. We uniquely couple expert study design consultation with rich data sets to enhance the success of late phase studies, helping you achieve both your scientific and commercial objectives while maintaining regulatory compliance.
Wide-ranging late phase research capabilities
i3 Innovus specializes in the design, implementation, and results dissemination of the following types of late phase research:
- Registries—disease, product, and safety
- Phase IV trials—approved product, same or new indications
- Consumer health care/OTC trials
- Community-based and naturalistic studies
- Health economics and outcomes research (prospective, observational studies)—cost-effectiveness, burden of illness, PRO/QoL, chart review, survey (direct to physicians or patients)
- Health economic piggyback trials
Members of the i3 Innovus research team have backgrounds in diverse areas, including the pharmaceutical industry, academia, pharmacology, health economics, epidemiology, and marketing. Our late phase research team has access to longitudinal health data for millions of covered patient lives and nearly half a million physicians. This unique data asset includes such health care data sets as administrative data, pharmacy claims data, physician and hospital claims data, laboratory results data, and socioeconomic elements.
www.i3global.com/businesses/i3innovus
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Parexel
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 For over 25 years PAREXEL has provided pharmaceutical and biotechnology companies with local and international clinical research services to support late phase clinical studies through to commercialization.
Our global presence and dedicated peri-and-post-approval expertise enables us to assist in the localization and customization of study design in many therapeutic areas including Oncology, Cardiovascular, Central Nervous System, and Infectious Disease.
PAREXEL has conducted over 600 Late Phase studies in the past five years involving nearly one million patients in more than 70 countries and including over 5,000 sites.
With locations in the Americas, Europe and Asia our team of highly qualified peri-and-post-approval specialists work along side our customers, adding value to both new and established products.
PAREXEL is dedicated to the unique adaptation of services to meet the needs of late phase programs.
www.parexel.com
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Medidata Solutions Worlwide
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 Medidata Solutions is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer™), investigator benchmarking and budgeting (Medidata Grants Manager™), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor™), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave®). Medidata’s diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.
www.mdsol.com
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PharmaNet
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 PharmaNet Development Group, a global drug development services company, provides clinical development solutions including consulting services, Phase I clinical studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses and Phase II, III, and IV clinical development studies.
PharmaNet offers a comprehensive range of services for early stage programs including Phase I/IIa and bioequivalence studies and bioanalytical services. Our global network of resources includes three clinics and two bioanalytical laboratories.
For Phase II–IV, PharmaNet offers a comprehensive range of clinical development services. Dedicated specialty teams conduct studies in virtually all therapeutic and specialty areas, including oncology, cardiology, dermatology, infectious diseases, neurosciences, ophthalmology, women’s health and pediatrics. These PharmaNet teams have the capabilities and dedicated resources to implement programs of any scale, regional and global.
Our dedicated Phase IV Development team has extensive experience in (Phase IIIb–IV) surveys, registries, and programs. PharmaNet professionals are experts at handling the complexities of late phase studies and are able to design and execute studies that meet the highest standards of scientific integrity and regulatory compliance while meeting commercial objectives.
PharmaNet consulting professionals are available to assist clients in the navigation of the clinical development process. Senior-level leaders with established credentials, proven experience and insight acquired through working with US and international regulatory agencies provide product development expertise, identify risk and develop risk minimization strategies, respond to changes in the regulatory environment and address challenges throughout the development process.
www.pharmanet.com
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Chiltern
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 Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas in more than 40 countries, and employs 1400 staff across 29 countries in 25 offices. Chiltern provides services including Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Further information is available at www.chiltern.com.
Services offered: Late Phase - peri-approval interventional/non-interventional studies Phase IIIb and IV, post-approval safety studies, registries, observational studies, medical/drug utilisation studies, expanded access programmes, Call Centre services. Full service for all projects: Project Management, Clinical Trial Monitoring/remote monitoring, Data Management, European Marketing Application/MAA Preparation, Medical Writing, NDA Preparation, Pharmacovigilance, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Clinical Study Reports
www.chiltern.com
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NNIT
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 NNIT is one of Europe’s leading consultancies in the development, implementation, validation and operation of IT for the life sciences industry. We create value for our clients by treating their IT as if it was our own, and of course, we meet the industry’s strictest requirements for quality. For over a decade, we have applied the latest advances in technology to make our clients’ software, business processes and communication more effective. NNIT employs nearly 1,300 people and in 2008, our turnover exceeded €185 million.
www.nnit.com
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Dr Ellen Strahlman
Chief Medical Officer
GlaxoSmithKline
Dr Clive Morris
Medical Science Director
AstraZeneca
Mark Latymer
Scientific Advisor
Pfizer
Amy Sing
Associate Group Director - Post Marketing
Genentech
Professor Markus Kosch
Associate Medical Director
Wyeth Pharma
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