Pharmaceutical Outsourcing: Discovery and Preclinical Services

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Publisher : Lulu.com
ISBN 13 : 0984904905
Total Pages : 277 pages
Book Rating : 4.9/5 (849 download)

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Book Synopsis Pharmaceutical Outsourcing: Discovery and Preclinical Services by : William C. Stevens Jr.

Download or read book Pharmaceutical Outsourcing: Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!

Outsourcing Resources for the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 114 pages
Book Rating : 4.:/5 (497 download)

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Book Synopsis Outsourcing Resources for the Pharmaceutical Industry by :

Download or read book Outsourcing Resources for the Pharmaceutical Industry written by and published by . This book was released on 2001 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing of R&D in the Pharmaceutical Industry

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Author :
Publisher : Springer
ISBN 13 : 0230512631
Total Pages : 205 pages
Book Rating : 4.2/5 (35 download)

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Book Synopsis Outsourcing of R&D in the Pharmaceutical Industry by : Bianca Piachaud

Download or read book Outsourcing of R&D in the Pharmaceutical Industry written by Bianca Piachaud and published by Springer. This book was released on 2004-09-30 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualisation, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.

Outsourcing in the Pharmaceutical Industry

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Publisher :
ISBN 13 : 9781853346132
Total Pages : 116 pages
Book Rating : 4.3/5 (461 download)

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Book Synopsis Outsourcing in the Pharmaceutical Industry by : Patrick Taaffe

Download or read book Outsourcing in the Pharmaceutical Industry written by Patrick Taaffe and published by . This book was released on 1996 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide

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Author :
Publisher : Pharmalicensing
ISBN 13 : 1905310110
Total Pages : 130 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide by :

Download or read book Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide written by and published by Pharmalicensing. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services

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Author :
Publisher : Universal-Publishers
ISBN 13 : 1599427095
Total Pages : 187 pages
Book Rating : 4.5/5 (994 download)

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Book Synopsis The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services by : T. R. Ramanathan

Download or read book The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services written by T. R. Ramanathan and published by Universal-Publishers. This book was released on 2009-03 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research study seeks to understand the nature of organisational change with respect to offshore outsourcing of information technology services in a multinational pharmaceutical company, and to examine the effectiveness of approaches used to manage this change so that lessons may be drawn from these experiences. Despite the abundant literature on effective organisational change management, the key factors that need to be managed properly at different stages of the offshore outsourcing process are not well understood. The research adopts a processual view to paint a broad picture of the issues involved in these different stages. A generic process model of change, based on the review of the change literature, was first developed to represent how change was intended to occur. This model focuses on the following four stages in the change process: context, diagnosis and planning, implementation, and institutionalisation. The research employs an interpretive case study approach and draws on fieldwork from three independent information systems departments (cases) of the company, where offshore outsourcing programmes were implemented. Qualitative data from semi-structured interviews, direct observation and document analysis are analysed by applying the generic process model to produce a detailed account of the way in which change was managed in the case organisations. The findings reveal that a combination of contextual factors, both external and internal to the company, influenced the adoption and use of offshore outsourcing in the case organisations. Externally, the economic forces were found to be the main catalyst for the change, while internally the role of the executive leadership and the lack of internal resources further explain the motivations behind the adoption of offshore outsourcing. The study illustrates that achieving successful outcomes from offshore outsourcing activities critically depends on the organisation adequately addressing a number of factors, such as conveying a sense of urgency, developing and communicating the vision, identifying the benefits of change and how they will be delivered, generating short-term wins, providing education and training, developing a fit between the change and organisational culture, etc., throughout the change process. The findings also highlight the effects of offshore outsourcing on the case organisations, including change in job roles and responsibilities and organisational learning activities that enable corrective actions to improve change management efforts. An important contribution of this research is the development of a model providing a more comprehensive understanding of the change process associated with the implementation of offshore IT outsourcing. Recommendations for policy makers and change managers to improve change management practice based on the research findings, as well as recommendations for further research, form a significant part of the conclusions.

Outsourcing Clinical Research Projects

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Publisher : Inst of Clinical Research
ISBN 13 : 1905238053
Total Pages : 40 pages
Book Rating : 4.9/5 (52 download)

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Book Synopsis Outsourcing Clinical Research Projects by : David Bryde

Download or read book Outsourcing Clinical Research Projects written by David Bryde and published by Inst of Clinical Research. This book was released on 2007 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor.

Outsourcing in Clinical Drug Development

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Publisher : CRC Press
ISBN 13 : 9781574911121
Total Pages : 268 pages
Book Rating : 4.9/5 (111 download)

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Book Synopsis Outsourcing in Clinical Drug Development by : Roy Drucker

Download or read book Outsourcing in Clinical Drug Development written by Roy Drucker and published by CRC Press. This book was released on 2002-08-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

Outsourcing Research in the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 222 pages
Book Rating : 4.:/5 (337 download)

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Book Synopsis Outsourcing Research in the Pharmaceutical Industry by : Francois Thomas

Download or read book Outsourcing Research in the Pharmaceutical Industry written by Francois Thomas and published by . This book was released on 1995 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing Biopharma R&D to India

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Author :
Publisher : Elsevier
ISBN 13 : 1908818018
Total Pages : 133 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Outsourcing Biopharma R&D to India by : P R Chowdhury

Download or read book Outsourcing Biopharma R&D to India written by P R Chowdhury and published by Elsevier. This book was released on 2011-05-05 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

Contract Research and Development Organizations

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Publisher : Springer Science & Business Media
ISBN 13 : 146140049X
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Contract Research and Development Organizations by : Shayne C. Gad

Download or read book Contract Research and Development Organizations written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2011-08-04 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Contract Manufacturing of Medicines

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Author :
Publisher : Kluwer Law International B.V.
ISBN 13 : 9041126422
Total Pages : 462 pages
Book Rating : 4.0/5 (411 download)

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Book Synopsis Contract Manufacturing of Medicines by : Magdalena Krekora

Download or read book Contract Manufacturing of Medicines written by Magdalena Krekora and published by Kluwer Law International B.V.. This book was released on 2008-01-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and• definition of and‘medicineand’ in different jurisdictions; and• categories of medicines; and• manufacturing and importation regulation in numerous jurisdictions worldwide; and• inspection regimes; and• good manufacturing practice (GMP); and• marketing authorization; and• manufacturing documentation; and• complaints and product recall; and• liability insurance; and• protection of trade secrets; and• data exclusivity and data protection; and• deficiencies and delays; and and• recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Pharmaceutical Outsourcing Opportunities Post Launch

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Publisher :
ISBN 13 : 9781562419486
Total Pages : 217 pages
Book Rating : 4.4/5 (194 download)

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Book Synopsis Pharmaceutical Outsourcing Opportunities Post Launch by : Anne Anscomb

Download or read book Pharmaceutical Outsourcing Opportunities Post Launch written by Anne Anscomb and published by . This book was released on 2004 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Offshoring Outsourcing in the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.:/5 (634 download)

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Book Synopsis Offshoring Outsourcing in the Pharmaceutical Industry by : Pascal Stiefenhofer

Download or read book Offshoring Outsourcing in the Pharmaceutical Industry written by Pascal Stiefenhofer and published by . This book was released on 2004 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Offshoring and Outsourcing of Core Corporate Activities

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Publisher :
ISBN 13 :
Total Pages : 219 pages
Book Rating : 4.:/5 (66 download)

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Book Synopsis Offshoring and Outsourcing of Core Corporate Activities by : Pooja Thakur

Download or read book Offshoring and Outsourcing of Core Corporate Activities written by Pooja Thakur and published by . This book was released on 2010 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dissertation examines the offshoring and outsourcing of core activities in the pharmaceutical industry. Using primary and secondary data sources, the dissertation adopts a multi-level approach to examine four research questions related to the sourcing strategies of core activities such as clinical trials. Specifically, I look at operational and strategic factors that influence the decision to relocate core activities both organizationally (in-house versus external vendors) and geographically (activities conducted in home nation versus trials in foreign countries). Drawing on Dunning's framework, the dissertation next examines the role of four motives (resource, market, efficiency and strategic asset seeking) in the offshoring decisions while distinguishing between offshore outsourcing and offshoring to foreign affiliates. Using multiple case studies, the third study further investigates the evolution of firms sourcing strategies from conducting core activities in-house to increasingly outsourcing and offshoring them. The final study in the dissertation examines the impact of offshoring and outsourcing on the performance of core activities. Data for this dissertation comes from multiple sources: Primary data from in-depth structured interviews and online survey of vice presidents of clinical affairs of pharmaceutical and biotechnology firms, as well as secondary data from Medidata, Orbis, and World Development Indicators. The dissertation offers evidence that firms tend to use different sourcing strategies for different motives. Specifically, offshoring to foreign affiliates is primarily driven by strategic factors and firms tend to prefer this strategy for strategic asset seeking purposes. Offshore outsourcing on the other hand is motivated by resource and efficiency seeking behavior and the important determinants for this strategy are mainly operational. The third type of sourcing strategy is domestic outsourcing and firms are driven by both strategic as well as operational determinants for this strategy. The qualitative study on strategy evolution points towards a five stage process which begins with in-house sourcing followed by domestic outsourcing, foreign affiliates, offshore outsourcing and finally backsourcing of core activities. Evidence from the dissertation suggests that outsourcing has a positive impact on performance when compared to in-house while offshoring has a negative impact compared to domestic sourcing.

Analysis: Outlook on Pharmaceutical Industry Outsourcing Trends

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Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (876 download)

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Book Synopsis Analysis: Outlook on Pharmaceutical Industry Outsourcing Trends by : 廖珮君

Download or read book Analysis: Outlook on Pharmaceutical Industry Outsourcing Trends written by 廖珮君 and published by . This book was released on 2013 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing in Drug Discovery

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Author :
Publisher : Find/Svp
ISBN 13 : 9781562418359
Total Pages : 239 pages
Book Rating : 4.4/5 (183 download)

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Book Synopsis Outsourcing in Drug Discovery by : Jack H. Gardner

Download or read book Outsourcing in Drug Discovery written by Jack H. Gardner and published by Find/Svp. This book was released on 2003-01-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: