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91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D 15 500 R&D Employees. Merck in US/Canada, MSD Worlwide Announcement in 2009 of US Merge of Merck & Co and Schering Plough MSD France implemented on July 1st 2011. Asthma Atherosclerosis Diabetes - PowerPoint PPT Presentation
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91,000 employees 46 M$ revenue (2010)
140 countries
8.1 M$ investments in R&D 15 500 R&D Employees
Merck in US/Canada, MSD Worlwide
Announcement in 2009 of US Merge of Merck & Co and Schering Plough
MSD France implemented on July 1st 2011
Asthma Atherosclerosis Diabetes Hepatitis C HIV Rheumatoid Arthritis
Innovation in Therapeutic Areas Alzheimer disease Oncology Thrombosys Hypertension Vaccines
Pipeline Merck as of Nov11
Les essais cliniques internationaux et leur monitoring :
Quels sont les facteurs clés de succès ?
Présentation RPS
Established in 1998 – Privately held
Over 3,000 employees Operations in 45 countries
throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions Ongoing expansion and
infrastructure development in Middle East and Africa
Recognized as one of fastest growing companies in clinical research industry, 33.7%+ CAGR from 2005-10 RPS listed 8th in the Top 11*
CROs (based on fiscal revenue) *Source: Contract Pharma June
2010
New Model
Les essais internationnaux multicentriques
Sponsor Change in the R&D Model Outsourcing strategies to the CROs.
Projects Global studies Regional Studies Local studies
Monitoring Activities in different countries. The influence of the culture. The profile of the Investigators and site facilities. The Profile of CRAs
Role of the CRA and Future development
Summary
Changes in R&D Models
Changes due to Risk management strategy. Share the risk Disconnect Product development management risk/
human resource management Optimize the development cycle External acquisition of NME & partnerships Looking for more and more flexibility and capability to
adapt to a changing environment (Law, country price policy, reimbursement…..)
Significant Geographic Shift of Clinical trials to Asia Pacific Region
Source: Jefferies & Co. Inc. Survey of Outsourcing Biopharma R&D Professionals, April 22, 2008
Confidential
Outsourcing Strategies to the CROs
Types of Outsourcing Strategies. Embedded Solutions Full Service - Outsource part or all scope of work
• Activities (Reg. Affairs, MV, PM, MW, DM, etc…)• Region – Part of the monitoring activities to 1 or more CROs.
Management Strategies Centralized – Based in the Headquarter Decentralized – In Partnership with Country offices
and/or CRO
Projects
Global Projects Usually performed by small and large pharma companies
together with global CROs. Large amount of countries. Challenge due to different requirements of the countries.
Regional Projects Usually performed by small and medium pharma companies or
biotechs together with global/Regional CROs. 3 – 10 countries normally involved
Local Projects Usually performed by Local affiliates, biotechs and Investigators
together with global/Regional CROs. 3 – 10 sites in one country
Projects – Conduct
What is Most Difficult : Local or Global Studies ?
Set up phase is more complex
Logistics and Management are more complicated
More and better possibilities for back up plans.
For large local studies recruitment can be challenging and difficult since it depends only on one market.
Less possibilities of rescue plans due to tight budget.
Requires a very good network of investigators
LocalGlobal
Projects – Monitoring Visits
Interim Monitoring Visit
Europe China
Preparation
Travel Time
Onsite Time
MVR and Follow Up
2h
8h
8h
4h
4h
15h
27h
6h
Example of differences
Difference in Cultures
Site and Investigators In China:
• several times investigators are government officials.• investigators usually go out for dinner with CRAs.
In Spain:• Pharmacy involvement is mandatory (Spanish Regulation).• The communication with the EC and RA are managed by Sponsor/CRO.• Existence of different Official Languages, Source Data/Medical Chart can
be written in any of those Official Languages. • Investigators performs their Clinical Trial responsibilities in their working
hours of normal medical practice. Working hours (from 08:00 to 15:00).• Few Private Medical cabinets participates in Clinical Trials.• Existence of Regional RA and EC that depending on the localization of
the investigator site may be involved . In Germany, Finland and Sweden investigators and site personnel
tend to be more organized and less flexible.
Difference in Cultures
CRAs Profile and Background
In Eastern Europe CRAs tend to medical doctors. In China and Asia in General CRAs have all kinds of
background. In Spain CRAs tend to be young (25-40 years old) and
Pharmacist or Biologist who have a master‘s in monitoring clinical trials.
International Monitoring
Roles and Future Development
Junior and Senior CRAs• Usually Responsible for sites in the country where he is based.• Mobility is difficult due to language, costs, culture, etc…• Senior CRA – In Europe 4-6 years experience while in China only 2
years is needed. Clinical Team Lead or Coordinator.
• Responsible for CRAs in regional/global studies.• Usually travel in the region for co-monitoring visits.• In Europe >5 years experience while in China only 3 years is needed.
Clinical Research Manager• Line Manager of the CRAs.
Local / International Project Manager.• Main point of contact to the client and responsible for the project.
International Monitoring
Key Success Factors Organized and assuring everything is well
documented.
Good Communication and social skills
English skills
Flexible making sure the work is done properly.
Ability to deliver according to the timelines.
Ability to understand the key points of the study.
Team work engagement.
International Monitoring
CRA in 2011: Sponsor’s Expectations
CRA core tasks and responsibilities knowledge is only a baseline, it’s all about :
PerformanceInitiative
CommunicationCommitment
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