Trial Prep for Paralegals
Trial Prep for Paralegals

Author: Michael L. Coyne

Publisher: Aspen Publishing

Published: 2020-01-05

Total Pages: 254

ISBN-13: 1601568045

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Trial Prep for Paralegals presents an in-depth guide for paralegals as they assist attorneys through all stages of litigation, from client intake to appeals. The book begins with an overview of the litigation process, provides a sample case to illustrate the paralegal’s role, and closes with helpful information on ethical dangers and how to handle stress. Professionalism, civility, and teamwork are emphasized, particularly the importance of working well with attorneys, the courts, opposing counsel, and, of course, the client. This helpful guidebook is a must-have for litigation paralegals. The authors substantially revised this Second Edition to reflect the increased role technology plays in the law office and in litigation. It incorporates the latest amendments to the federal rules, including changes to discovery practice found in Fed. R. Civ. P. 26. The two chapters on e-discovery were also substantially updated, and a new sample discovery plan was added. Issues regularly facing paralegals and attorneys are examined, including the paralegal’s appropriate role and responsibility to timely communicate with clients.

A Practical Guide to Quality Management in Clinical Trial Research
A Practical Guide to Quality Management in Clinical Trial Research

Author: Graham Ogg

Publisher: CRC Press

Published: 2005-11-01

Total Pages: 229

ISBN-13: 104006163X

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Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co

Managing E-discovery and ESI
Managing E-discovery and ESI

Author: Michael Berman

Publisher: American Bar Association

Published: 2011

Total Pages: 0

ISBN-13: 9781616329730

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The legal landscape, and litigation, have changed markedly in the last decade.This book identifies the key issues related to ESI--pre-litigation management, preservation, collection, processing, review, production, and use in deposition and at trial--and provides clear, practical guidance to litigators. The book is divided into eight parts that follow the sequence from the pre-litigation stage through trial.

Training on Trial
Training on Trial

Author: James D. Kirkpatrick

Publisher: HarperChristian + ORM

Published: 2022-03-29

Total Pages: 256

ISBN-13: 0814414702

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Using a courtroom trial as a metaphor, Training on Trial seeks to get to the truth about why training fails and puts the business partnership model to work for real. While upbeat lingo abounds about “complementing strategic objectives” and “driving productivity,” the fact is that most training does not make a significant enough impact on business results, and when it does, training professionals fail to make a convincing case about the value added to the bottom line. The vaunted “business partnership model” has yet to be realized?and in tough economic times, when the training budget is often the first to be cut, training is on trial for its very existence. Readers on both sides of the “courtroom” will learn how to: Build expertise and become genuinely involved in your company's or client's business Pledge to work together to positively impact a pressing business need or pivotal business opportunity Ask the jury their expectations and revise your own to be more realistic and mutually satisfying Develop a plan, targeting the key drivers of performance success after training has taken place Execute your initiative and deliver a stellar ROESM (Return on Expectations) A thought-provoking read for trainers and business unit leaders alike, Training on Trial provides a new application of the Kirkpatrick Four-Level Evaluation Model and a multitude of tips and techniques that allow lessons learned to be put into action now.

A Practical Guide to Managing Clinical Trials
A Practical Guide to Managing Clinical Trials

Author: JoAnn Pfeiffer

Publisher: CRC Press

Published: 2017-05-18

Total Pages: 292

ISBN-13: 1315299771

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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

The Prevention and Treatment of Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

A Manager's Guide to the Design and Conduct of Clinical Trials
A Manager's Guide to the Design and Conduct of Clinical Trials

Author: Phillip I. Good

Publisher: John Wiley & Sons

Published: 2006-04-28

Total Pages: 272

ISBN-13: 0471930873

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This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry