Managing Contract Research Programs

Author : Eugene F. Reilly
Publisher : Transportation Research Board
ISBN 13 : 9780309060011
Total Pages : 104 pages
Book Rating : 4.1X/5 ( download)

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Download or read book Managing Contract Research Programs written by Eugene F. Reilly and published by Transportation Research Board. This book was released on 1996 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The synthesis describes the state of the practice for managing contract research programs. Data presented were obtained from a review of the literature, a survey of state departments of transportation (DOTs), and interviews of selected state DOT, Federal Highway Administration, Transportation Research Board, and university professionals."--Avant-propos.

Author :
Publisher :
ISBN 13 :
Total Pages : 92 pages
Book Rating : 4.88/5 ( download)

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Download or read book Managing Contract Research Programs written by and published by . This book was released on 1996 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Alexey Levashov
Publisher : Litres
ISBN 13 : 5040664451
Total Pages : 83 pages
Book Rating : 4.50/5 ( download)

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Download or read book Project Management in Clinical Trials written by Alexey Levashov and published by Litres. This book was released on 2021-05-25 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life and practical tips.

Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 9781134424849
Total Pages : 188 pages
Book Rating : 4.41/5 ( download)

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Download or read book The Selection and Use of Contract Research Organizations written by Shayne C. Gad and published by CRC Press. This book was released on 2004-06-02 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your essential guide to choosing the best provider. A history of the CRO industry, audit checklists, and overviews of both the pharmaceutical and medical device development processes create a comprehensive overview of how to successfully select and manage a CRO for your project. The book also discusses: Guidance for selection, protocol and contract development, project management and monitoring of work Common pitfalls and problems - how to avoid them, and how to solve them if they do occur How to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and timely production Prototype forms and templates for increasing coordination between multiple working groups A series of appendices covering hundreds of prominent service providers worldwide, including contact information Operative regulations and laws In addition to providing fundamental guidance on how to select and manage a CRO in the product development process, this reference also includes a set of eight databases that contain contact information for prominent service providers in North America, Europe, and Japan, and overviews of services they offer. It is a complete resource for professionals in biotechnology, and pharmaceutical and medical device development.

Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 146140049X
Total Pages : 213 pages
Book Rating : 4.93/5 ( download)

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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.

Author : Thomas B. Deen
Publisher : Transportation Research Board
ISBN 13 : 9780309068581
Total Pages : 76 pages
Book Rating : 4.84/5 ( download)

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Download or read book Seven Keys to Building a Robust Research Program written by Thomas B. Deen and published by Transportation Research Board. This book was released on 1999 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies attributes necessary to build and maintain a robust research program.

Author : Gerardus Blokdyk
Publisher : 5starcooks
ISBN 13 : 9780655189497
Total Pages : 128 pages
Book Rating : 4.91/5 ( download)

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Download or read book Contract Research Organization the Ultimate Step-By-Step Guide written by Gerardus Blokdyk and published by 5starcooks. This book was released on 2018-05-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Who are the Contract research organization improvement team members, including Management Leads and Coaches? Is a fully trained team formed, supported, and committed to work on the Contract research organization improvements? What is Effective Contract research organization? How did the Contract research organization manager receive input to the development of a Contract research organization improvement plan and the estimated completion dates/times of each activity? How do we manage Contract research organization Knowledge Management (KM)? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Contract research organization investments work better. This Contract research organization All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Contract research organization Self-Assessment. Featuring 700 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Contract research organization improvements can be made. In using the questions you will be better able to: - diagnose Contract research organization projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Contract research organization and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Contract research organization Scorecard, you will develop a clear picture of which Contract research organization areas need attention. Your purchase includes access details to the Contract research organization self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. Your exclusive instant access details can be found in your book.

Author : David Bryde
Publisher : Inst of Clinical Research
ISBN 13 : 1905238053
Total Pages : 40 pages
Book Rating : 4.57/5 ( download)

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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.

Author : David Robert Thomas
Publisher : SAGE Publications
ISBN 13 : 184860193X
Total Pages : 265 pages
Book Rating : 4.32/5 ( download)

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Download or read book Designing and Managing Your Research Project written by David Robert Thomas and published by SAGE Publications. This book was released on 2010-10-04 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information about the key areas needed for a successful project. It includes software skills, developing research objectives, writing proposals, literature reviews, getting ethics approval, seeking funding, managing a project, communicating research findings, and writing reports. There is also a chapter on working as an independent researcher. The book includes numerous examples, checklists, and practical exercises designed to assist the learning of research skills and the completion of crucial project tasks. It covers procedures needed for conducting projects electronically and accessing information from the Internet.

Author : Louisiana. Natural Resources & Energy Division
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.93/5 ( download)

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Download or read book An Extended Contract Research Program : Energy Development and Management written by Louisiana. Natural Resources & Energy Division and published by . This book was released on 1975 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: