Image Solutions, Inc. (ISI) Announces Offerings for Global Life Sciences Companies Coordinating with Local Operating Companies on Multi-Region Submissions
WHIPPANY, N.J. - (BUSINESS WIRE) - Image Solutions, Inc. (ISI), a leading provider of software and services for the life sciences industry, today unveiled its strategy and offering for global pharmaceutical companies interested in optimizing submission processes between headquarter operations and their local operating companies (LOCs), also known as affiliates. The comprehensive set of tools and services will help life sciences firms bring new therapies to market more efficiently.
Advances in the standardization of formats and for regulatory submissions are providing global life sciences companies the opportunity to empower their LOCs to make local regulatory filings by reusing content from headquarter-created Master Dossiers and incorporating local requirements. ISI's offerings leverage consulting, services, outsourcing and technology resources; a deep knowledge of regulatory standards and trends; and comprehensive analysis that examines various operational approaches to achieve true optimization.
The ISI Approach
Nearly every pharmaceutical company has a different model, strategy and approach to local market submissions. Most fall into one of two categories: the centrally managed model where headquarters determines the technology and processes and is responsible for coordinating efforts; and the decentralized model in which affiliates determine their own needs and processes and invest accordingly.
ISI's offerings accommodate both situations and a wide range of needs. For example, a company with affiliates that have the staff and know-how to assemble and oversee a submission will likely leverage a centrally deployed tool to publish their submissions. In this scenario, ISI provides a software-as-a-service based deployment of its market-leading software products eCTDXPress and ISIPublisher. Organizations that do not have the resources or infrastructure, or that need to plan for peaks and valleys in submission volume, may explore outsourcing services. ISI supports its clients through submission centers in the Whippany, NJ and San Bruno, CA in the U.S.; Frankfurt, Germany; and Tianjin China. In this scenario, ISI can either extend its own technology so ISI experts can work alongside local company regulatory staff to compile a submission or leverage a company's own technology. Finally, many companies require a blended approach where they tap ISI for its technology, capabilities, and offshore support for the most efficient infrastructure at the lowest cost.
The newest and most prevalent standard for electronic drug submissions, the electronic Common Technical Document (eCTD), has ushered in a wave of decision-making for multi-national companies that must now also accommodate various submission formats and procedures, particularly in Europe where there are three methods to submit: 1) the European centralized procedure, 2) the decentralized procedure, and 3) the mutual recognition procedure.
Founded in Research
The adaptable approach to optimizing submission processes is the result of comprehensive research, both qualitative and quantitative. ISI recently conducted a panel discussion of regulatory experts from large and midsize biopharmaceutical companies where they discussed relationships between headquarter operations and local operating companies; the goal of making simultaneous global submissions; transparency and consistency of regulatory submissions; the move to the eCTD; and lifecycle management. ISI also recently completed a survey of 130 biopharmaceutical executives that revealed three key trends:
• More companies are taking a centralized approach to working with local operating companies (81.5%)
• Most companies are in the early phases of figuring out their LOC strategy (66.2%)
• The two biggest challenges for companies working with affiliates are decentralized processes and systems (39.2%) and affiliates' lack of knowledge of eCTD and submissions (36.2%).
"At the same time life sciences organizations are under extreme cost pressure, they are facing greater drug submission volumes, which means many do not have the resources to dedicate to LOC management and operation," said Adam Sherlock, Managing Director for ISI's European Operations. "Our research has revealed a demand for trusted partners that can guide multinational pharmaceutical companies through this process - ISI has the experience and tools to meet this demand."
The Industry Need for LOC Oversight
The recent wave of mergers and acquisitions in the pharmaceutical industry has accelerated the global footprint of many of the world's leading pharmaceutical companies. Many medium and large multinational pharmaceutical already have complex affiliate company networks in place, which can make the sharing of critical regulatory information difficult; industry consolidation will exacerbate the challenge. Commonly, international organizations also have limited infrastructure and resources to reuse information across geographies to streamline the drug submission and approval process. While the standardization of the eCTD helps, every market is different and local nuances require local market expertise. Leaning on LOCs for local market guidance, however, is not easy. In many markets there are talent gaps, inexperience with eCTD or non-eCTD (NeeS) standards, high turnover rates - as high as 25-30% according to some of ISI's leading top-tier clients - and an inconsistent workflow, which can create additional demands.
"LOCs hold the key to simplifying submission and approval processes for both new and existing therapies, yet they lack many of the vital resources required to efficiently bring life-improving drugs to market," said Sherlock. ISI will cover this topic in depth during the company's annual eSolutions Conference, Accelerating Change in the New R&D Paradigm to be held in Barcelona, Spain on September 29-30, 2009. Speakers will include Graham Shelvey, Senior Director, Worldwide Regulatory Operations, sanofi-aventis; Geoffrey Williams, e-Regulatory Liaison, Roche Products, Ltd.; and Rene Jansen, Global Submission Operations, EMEA Lead, Johnson & Johnson Pharma.
ISI's report, Around the World in Many Ways: Developing Models to Support Affiliate Regulatory Submissions, is available upon request. The report details best practices for multimarket submissions based on feedback from business leaders at large, small and midsize biopharmaceutical companies.
ISI's webinar, Collaborating with Local Operating Companies on Multi-Region Submissions, is also available upon request. The webinar outlines optimum strategies and solutions for overcoming cultural, economic and regulatory differences between countries.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organizations. For more information, visit the company website at www.imagesolutions.com.
Advances in the standardization of formats and for regulatory submissions are providing global life sciences companies the opportunity to empower their LOCs to make local regulatory filings by reusing content from headquarter-created Master Dossiers and incorporating local requirements. ISI's offerings leverage consulting, services, outsourcing and technology resources; a deep knowledge of regulatory standards and trends; and comprehensive analysis that examines various operational approaches to achieve true optimization.
The ISI Approach
Nearly every pharmaceutical company has a different model, strategy and approach to local market submissions. Most fall into one of two categories: the centrally managed model where headquarters determines the technology and processes and is responsible for coordinating efforts; and the decentralized model in which affiliates determine their own needs and processes and invest accordingly.
ISI's offerings accommodate both situations and a wide range of needs. For example, a company with affiliates that have the staff and know-how to assemble and oversee a submission will likely leverage a centrally deployed tool to publish their submissions. In this scenario, ISI provides a software-as-a-service based deployment of its market-leading software products eCTDXPress and ISIPublisher. Organizations that do not have the resources or infrastructure, or that need to plan for peaks and valleys in submission volume, may explore outsourcing services. ISI supports its clients through submission centers in the Whippany, NJ and San Bruno, CA in the U.S.; Frankfurt, Germany; and Tianjin China. In this scenario, ISI can either extend its own technology so ISI experts can work alongside local company regulatory staff to compile a submission or leverage a company's own technology. Finally, many companies require a blended approach where they tap ISI for its technology, capabilities, and offshore support for the most efficient infrastructure at the lowest cost.
The newest and most prevalent standard for electronic drug submissions, the electronic Common Technical Document (eCTD), has ushered in a wave of decision-making for multi-national companies that must now also accommodate various submission formats and procedures, particularly in Europe where there are three methods to submit: 1) the European centralized procedure, 2) the decentralized procedure, and 3) the mutual recognition procedure.
Founded in Research
The adaptable approach to optimizing submission processes is the result of comprehensive research, both qualitative and quantitative. ISI recently conducted a panel discussion of regulatory experts from large and midsize biopharmaceutical companies where they discussed relationships between headquarter operations and local operating companies; the goal of making simultaneous global submissions; transparency and consistency of regulatory submissions; the move to the eCTD; and lifecycle management. ISI also recently completed a survey of 130 biopharmaceutical executives that revealed three key trends:
• More companies are taking a centralized approach to working with local operating companies (81.5%)
• Most companies are in the early phases of figuring out their LOC strategy (66.2%)
• The two biggest challenges for companies working with affiliates are decentralized processes and systems (39.2%) and affiliates' lack of knowledge of eCTD and submissions (36.2%).
"At the same time life sciences organizations are under extreme cost pressure, they are facing greater drug submission volumes, which means many do not have the resources to dedicate to LOC management and operation," said Adam Sherlock, Managing Director for ISI's European Operations. "Our research has revealed a demand for trusted partners that can guide multinational pharmaceutical companies through this process - ISI has the experience and tools to meet this demand."
The Industry Need for LOC Oversight
The recent wave of mergers and acquisitions in the pharmaceutical industry has accelerated the global footprint of many of the world's leading pharmaceutical companies. Many medium and large multinational pharmaceutical already have complex affiliate company networks in place, which can make the sharing of critical regulatory information difficult; industry consolidation will exacerbate the challenge. Commonly, international organizations also have limited infrastructure and resources to reuse information across geographies to streamline the drug submission and approval process. While the standardization of the eCTD helps, every market is different and local nuances require local market expertise. Leaning on LOCs for local market guidance, however, is not easy. In many markets there are talent gaps, inexperience with eCTD or non-eCTD (NeeS) standards, high turnover rates - as high as 25-30% according to some of ISI's leading top-tier clients - and an inconsistent workflow, which can create additional demands.
"LOCs hold the key to simplifying submission and approval processes for both new and existing therapies, yet they lack many of the vital resources required to efficiently bring life-improving drugs to market," said Sherlock. ISI will cover this topic in depth during the company's annual eSolutions Conference, Accelerating Change in the New R&D Paradigm to be held in Barcelona, Spain on September 29-30, 2009. Speakers will include Graham Shelvey, Senior Director, Worldwide Regulatory Operations, sanofi-aventis; Geoffrey Williams, e-Regulatory Liaison, Roche Products, Ltd.; and Rene Jansen, Global Submission Operations, EMEA Lead, Johnson & Johnson Pharma.
ISI's report, Around the World in Many Ways: Developing Models to Support Affiliate Regulatory Submissions, is available upon request. The report details best practices for multimarket submissions based on feedback from business leaders at large, small and midsize biopharmaceutical companies.
ISI's webinar, Collaborating with Local Operating Companies on Multi-Region Submissions, is also available upon request. The webinar outlines optimum strategies and solutions for overcoming cultural, economic and regulatory differences between countries.
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organizations. For more information, visit the company website at www.imagesolutions.com.