Managing Contract Research Programs

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Author :
Publisher : Transportation Research Board
ISBN 13 : 9780309060011
Total Pages : 104 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Managing Contract Research Programs by : Eugene F. Reilly

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.

Seven Keys to Building a Robust Research Program

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Publisher : Transportation Research Board
ISBN 13 : 9780309068581
Total Pages : 76 pages
Book Rating : 4.0/5 (685 download)

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Book Synopsis Seven Keys to Building a Robust Research Program by : Thomas B. Deen

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.

Developing a Successful Clinical Research Program

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Author :
Publisher : Springer
ISBN 13 : 3319546937
Total Pages : 270 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Developing a Successful Clinical Research Program by : Cara East

Download or read book Developing a Successful Clinical Research Program written by Cara East and published by Springer. This book was released on 2018-08-08 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.

Designing and Managing Your Research Project

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Author :
Publisher : SAGE Publications
ISBN 13 : 184860193X
Total Pages : 265 pages
Book Rating : 4.8/5 (486 download)

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Book Synopsis Designing and Managing Your Research Project by : David Robert Thomas

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.

Principles and Practice of Clinical Research

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Author :
Publisher : Elsevier
ISBN 13 : 9780080539539
Total Pages : 490 pages
Book Rating : 4.5/5 (395 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2002-01-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research. Key Features * Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology * Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display * Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH * Excellent companion text for courses on clinical research

Special Report - Highway Research Board

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Publisher :
ISBN 13 :
Total Pages : 968 pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Special Report - Highway Research Board by : National Research Council (U.S.). Highway Research Board

Download or read book Special Report - Highway Research Board written by National Research Council (U.S.). Highway Research Board and published by . This book was released on 1968 with total page 968 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Highway Research News

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Author :
Publisher :
ISBN 13 :
Total Pages : 952 pages
Book Rating : 4.X/5 (1 download)

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Book Synopsis Highway Research News by :

Download or read book Highway Research News written by and published by . This book was released on 1968 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues for 1963- include section: Urban transportation research digest.

Contract Research Program

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Author :
Publisher :
ISBN 13 :
Total Pages : 344 pages
Book Rating : 4.2/5 (274 download)

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Book Synopsis Contract Research Program by : National Cancer Institute (U.S.). Division of Cancer Biology and Diagnosis

Download or read book Contract Research Program written by National Cancer Institute (U.S.). Division of Cancer Biology and Diagnosis and published by . This book was released on 1979 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing Clinical Research Projects

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Author :
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.

The Selection and Use of Contract Research Organizations

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Author :
Publisher : CRC Press
ISBN 13 : 9781134424849
Total Pages : 188 pages
Book Rating : 4.4/5 (248 download)

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Book Synopsis The Selection and Use of Contract Research Organizations by : Shayne C. Gad

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.

The Sourcebook for Clinical Research

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Author :
Publisher : Academic Press
ISBN 13 : 0128162430
Total Pages : 278 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Sourcebook for Clinical Research by : Natasha Martien

Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

Clinical Trial Project Management

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Author :
Publisher : Elsevier
ISBN 13 : 0443136289
Total Pages : 352 pages
Book Rating : 4.4/5 (431 download)

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Book Synopsis Clinical Trial Project Management by : Ashok Kumar Peepliwal

Download or read book Clinical Trial Project Management written by Ashok Kumar Peepliwal and published by Elsevier. This book was released on 2023-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470888962
Total Pages : 352 pages
Book Rating : 4.4/5 (78 download)

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Book Synopsis Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries by : Pete Harpum

Download or read book Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries written by Pete Harpum and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

Department of the Interior and Related Agencies Appropriations for 1993: Public witnesses for energy programs

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Publisher :
ISBN 13 :
Total Pages : 1300 pages
Book Rating : 4.0/5 (18 download)

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Book Synopsis Department of the Interior and Related Agencies Appropriations for 1993: Public witnesses for energy programs by : United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies

Download or read book Department of the Interior and Related Agencies Appropriations for 1993: Public witnesses for energy programs written by United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies and published by . This book was released on 1992 with total page 1300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Contract Research & Technology Program

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Author :
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Contract Research & Technology Program by : United States. Office of Naval Research

Download or read book Contract Research & Technology Program written by United States. Office of Naval Research and published by . This book was released on 1978 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Advanced Project Portfolio Management and the PMO

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Publisher : J. Ross Publishing
ISBN 13 : 9781932159028
Total Pages : 456 pages
Book Rating : 4.1/5 (59 download)

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Book Synopsis Advanced Project Portfolio Management and the PMO by : Gerald I. Kendall

Download or read book Advanced Project Portfolio Management and the PMO written by Gerald I. Kendall and published by J. Ross Publishing. This book was released on 2003-04-15 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Project Portfolio Management is a comprehensive book which presents a roadmap for the achievement of high value enterprise strategies and superior project management results. It provides methods for best project selection, faster completion, optimal project portfolio management, and how to explicitly measure the PMO for rapidly increasing project ROI.

Department of the Interior and Related Agencies Appropriations for 1993

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Author :
Publisher :
ISBN 13 :
Total Pages : 1296 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Department of the Interior and Related Agencies Appropriations for 1993 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies

Download or read book Department of the Interior and Related Agencies Appropriations for 1993 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies and published by . This book was released on 1992 with total page 1296 pages. Available in PDF, EPUB and Kindle. Book excerpt: