Advertisement
| clinical project management certification: Pharmaceutical and Biomedical Project Management in a Changing Global Environment Scott D. Babler, 2011-01-06 Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers. |
| clinical project management certification: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| clinical project management certification: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| clinical project management certification: Project Management for the Pharmaceutical Industry Laura Brown, Tony Grundy, 2016-04-08 The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management. |
| clinical project management certification: Clinical Trial Project Management Ashok Kumar Peepliwal, 2023-11-15 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 |
| clinical project management certification: Project Management for Healthcare Information Technology Scott Coplan, David Masuda, 2011-01-26 A Proven, Integrated Healthcare Information Technology Management Solution Co-written by a certified Project Management Professional and an M.D., Project Management for Healthcare Information Technology presents an effective methodology that encompasses standards and best practices from project management, information technology management, and change management for a streamlined transition to digital medicine. Each management discipline is examined in detail and defined as a set of knowledge areas. The book then describes the core processes that take place within each knowledge area in the initiating, planning, executing, controlling, and closing stages of a project. Real-world examples from healthcare information technology project leaders identify how the integrated approach presented in this book leads to successful project implementations. Coverage Includes: Integrating project, information technology, and change management methodologies PMBOK Guide process groups--initiating, planning, executing, controlling, and closing Project management knowledge areas--integration, scope, time, cost, quality, human resource, communication, risk, and procurement management IT management knowledge areas--user requirements, infrastructure, conversion, software configuration, workflow, security, interface, testing, cutover, and support management Change management knowledge areas--realization, sponsorship, transformation, training, and optimization management |
| clinical project management certification: Expert Judgment in Project Management Paul S. Szwed, 2016-04-01 Expert judgment is a major source of information that can provide vital input to project managers, who must ensure that projects are completed successfully, on time, and on budget. Too often, however, companies lack detailed processes for finding and consulting with experts—making it hard to match the required know-how with the project at hand. In Expert Judgment in Project Management: Narrowing the Theory-Practice Gap, Paul S. Szwed provides research that will help project managers become more adept at using expert judgment effectively. |
| clinical project management certification: Responsible Conduct of Research Adil E. Shamoo, David B. Resnik, 2009-02-12 Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today. |
| clinical project management certification: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| clinical project management certification: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| clinical project management certification: Principles of Good Clinical Practice Michael J. McGraw, 2010 Part of RPS Pharmacy Business Administration Series, this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights. |
| clinical project management certification: The Sourcebook for Clinical Research Natasha Martien, Jeff Nelligan, 2018-08-01 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 project management certification: Project Management for Healthcare David Shirley, 2011-04-25 As a growing number of healthcare organizations implement project management principles to improve cost and service efficiencies, they are in desperate need of resources that illustrate the project management needs of today’s healthcare professional. Project Management for Healthcare fills this need. Using easy-to-follow language, it explains how the time-tested principles of project management can help maximize limited resources and ensure the highest possible quality of care. Exploring the discipline of project management from the perspective of the healthcare environment, the book dissects the project process and provides the tools and techniques required to successfully plan, execute, and control any healthcare-based project. From identifying stakeholders to constructing a project plan, it covers the spectrum of project planning activities. Complete with chapter summaries, exercises, hints, review questions, and case studies, it illustrates applications across a range of healthcare settings. Explains how to utilize the project plan to execute projects within budget, schedule, and quality objectives Covers program management as it relates to healthcare Addresses the interaction between healthcare and information technology Presents best practices from the pharmaceutical and medical equipment industries—that can easily be adapted to any healthcare setting Because most healthcare personnel will inevitably have to work with program management and need to interact with pharmaceutical companies and medical device manufacturers, the book provides an inside look at the processes and best practices used to bring products to market in these industries. Explaining how to adapt these processes to drive down costs and improve the quality of care in any healthcare setting, the book includes a case study of a medical facility that illustrates the proper application of the tools and techniques needed to manage healthcare projects effectively and efficiently. |
| clinical project management certification: Project Manager Competency Development Framework Project Management Institute, 2017 Providing general context for the definition, assessment and development of project manager competency, this book outlines the key dimensions and identifies those competencies that are most likely to impact project manager performance. -- |
| clinical project management certification: Career Opportunities in Clinical Drug Research Rebecca Jane Anderson, 2010 It is simply amazing to me that so many of my industry coworkers stumbled upon their careers in clinical research, like I did, merely by chance. In most cases, once those opportunities were presented to us, we found fulfilling and successful careers. Undoubtedly, other eager job seekers would also find this career path attractive. If only someone would tell them about it. |
| clinical project management certification: Ethical and Regulatory Aspects of Clinical Research Ezekiel J. Emanuel, 2003 Professionals in need of such training and bioethicists will be interested. |
| clinical project management certification: CPHIMS Review Guide Himss, 2016-07-27 Whether you're taking the CPHIMS exam, or simply want the most current and comprehensive overview in healthcare information and management systems today - this completely revised and updated third edition has it all. But for those preparing for the CPHIMS exam, this book is an ideal study partner. The content reflects the exam content outline covering healthcare and technology environments; systems analysis, design, selection, implementation, support, maintenance, testing, evaluation, privacy and security; and administration leadership management. Candidates can challenge themselves with the sample multiple choice questions at the end of the book. |
| clinical project management certification: Alpha Project Managers Andy Crowe, 2006 Imagine having access to the top project managers from organizations and industries around the world. Imagine uncovering what they do, how they approach their challenges, and what they know. Alpha Project Managers: what the top 20% know that everyone else does not gets you inside the minds of these top managers and shares their practices, their attitudes, and their secrets. |
| clinical project management certification: Megaproject Organization and Performance Nuno Gil, Colm Ludrigan, Jeffrey Pinto, Phanish Puranam, 2017-07-24 Megaproject Organization and Performance: The Myth and Political Reality delves into the complex world of organizing megaprojects and investigates the extent to which the performance of these projects could be traced back to their organizational structure. Through multiple case study research, including the London Olympic Park and Heathrow Airport Terminal 2, the authors show how megaprojects are unique in how they are organized. They explore core-periphery relationships between promotors who control strategic choices, and suppliers, the contracted experts who provide the actual resources to get the project done. The implications of these structural–performance relationships within a robust economy are then compared with railroad and highway development projects in the developing economies of Nigeria, Uganda, and India. This in-depth study brings a complementary perspective to megaproject literature and enables us to reconcile conflicting explanations for the regularity with which megaprojects miss performance targets. With pluralism at the core of the megaproject's organizational structure, the authors argue that megaprojects work best when accountability is shared and everyone has a stake in the final outcome. |
| clinical project management certification: Research Project Management and Leadership P. Alison Paprica, 2024-01-31 The project management approaches, which are used by millions of people internationally, are often too detailed or constraining to be applied to research. In this handbook, project management expert P. Alison Paprica presents guidance specifically developed to help with the planning, management, and leadership of research. Research Project Management and Leadership provides simplified versions of globally utilized project management tools, such as the work breakdown structure to visualize scope, and offers guidance on processes, including a five-step process to identify and respond to risks. The complementary leadership guidance in the handbook is presented in the form of interview write-ups with 19 Canadian and international research leaders, each of whom describes a situation where leadership skills were important, how they responded, and what they learned. The accessible language and practical guidance in the handbook make it a valuable resource for everyone from principal investigators leading multimillion-dollar projects to graduate students planning their thesis research. The book aims to help readers understand which management and leadership tools, processes, and practices are helpful in different circumstances, and how to implement them in research settings. |
| clinical project management certification: Clinical Research Associate - The Comprehensive Guide VIRUTI SHIVAN, In a rapidly evolving field where precision and expertise can shape the future of healthcare, Clinical Research Associate - The Comprehensive Guide emerges as an indispensable resource for aspiring and established professionals alike. This guide dives deep into the heart of clinical trial management, offering a treasure trove of knowledge that spans the foundational basics to the intricacies of regulatory compliance, patient recruitment, data integrity, and beyond. With a focus on real-world applications and best practices, the book equips readers with the tools and insights needed to excel in their roles, navigate the challenges of the industry, and contribute to groundbreaking medical research. Given the specialized content, this guide intentionally omits images or illustrations to ensure a seamless reading experience while avoiding copyright issues, allowing the text to shine in its meticulous detail and expertly crafted narrative. The landscape of clinical research is one of constant innovation and stringent standards, making the role of the Clinical Research Associate more crucial than ever. This guide is not just a manual; it's a mentor in print, offering a blend of technical know-how, ethical considerations, and career advice to mold the next generation of industry leaders. Without the distraction of images or illustrations, every page invites the reader into a focused journey through the complexities and triumphs of clinical research. Whether you're taking your first steps in this dynamic field or looking to refine your expertise, this book stands as a beacon of knowledge, illuminating the path to excellence in clinical trial management. |
| clinical project management certification: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| clinical project management certification: Clinical Research Computing Prakash Nadkarni, 2016-04-29 Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. - Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples - Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings - Offers didactic content organization and an increasing complexity through the chapters |
| clinical project management certification: Pharmaceutical Project Management Anthony Kennedy, 2008-03-17 Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration |
| clinical project management certification: Clinical Engineering Handbook Ernesto Iadanza, 2019-12-06 Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. - Presents a definitive, comprehensive, and up-to-date resource on clinical engineering - Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more - Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering |
| clinical project management certification: The Emerald Handbook of Research Management and Administration Around the World Simon Kerridge, Susi Poli, Mariko Yang-Yoshihara, 2023-11-29 The ebook edition of this title is Open Access and freely available to read online. The most comprehensive book about practitioners working in research management and administration, with insights from around the globe and across disciplines to provide a comprehensive account of RMAs as a profession. |
| clinical project management certification: Organizational Enablers for Project Governance Ralf Müller, Jingting Shao, Sofia Pemsel, 2016-01-01 While corporate culture plays a significant role in the success of any corporation, governance and “governmentality” not only determine how business should be conducted, but also define the policies and procedures organizations follow to achieve business functions and goals. In their book, Organizational Enablers for Project Governance, Ralf M&üller, Jingting Shao, and Sofia Pemsel examine the interaction of governance and governmentality in various types of companies and demonstrate how these factors drive business success and influence project work, efficiency, and profitability. The data for the studies was collected through interviews with six companies in Sweden and China and a global web-based questionnaire that garnered 208 responses. Using this data the authors conducted four studies, employing various research methodologies, to investigate the different systems of governance and their relationships to organizational success. Based on these results, the authors discovered that organizational enablers (including key factors such as leadership, governance, and influence of project managers) have a critical impact on how organizations operate, adapt to market fluctuations and forces, and make essential changes over time. |
| clinical project management certification: Burst the Bubble Tia Warrick, 2024-02-21 Burst the Bubble is a comprehensive guide by Tia Warrick designed to demystify the clinical research industry and serve as an inspiring resource for individuals aspiring to enter this competitive field. The book explores various facets of clinical research, shedding light on different functions, key stakeholders, and the often-overlooked intricacies of the profession. The book aims to clarify the multifaceted nature of clinical research careers through engaging discussions, offering insights that can help readers make informed decisions about their professional paths. To make the reading experience interactive, the book incorporates question processes that guide readers in discovering the most suitable career within the clinical research landscape. Additionally, it offers a glimpse into the daily routines of specific roles, providing a firsthand account of the challenges and rewards inherent in each position. The recurring theme of Benefit or Bust underscores the importance of understanding the industry's nuances and making strategic choices for a successful and fulfilling career. Furthermore, the book goes beyond entry-level insights, catering to individuals who have experience in the field but may have only seen it from a limited perspective. With a commitment to sharing insider knowledge and trade secrets, Burst the Bubble aims to empower readers with the information needed to navigate the complexities of the clinical research industry and thrive in their chosen careers. Whether you're a newcomer eager to break into the field or a seasoned professional seeking a more comprehensive understanding, this book is your guide to unlocking the full potential of a career in clinical research. |
| clinical project management certification: Clinical Research Coordinator Handbook Deborrah Norris, 2004 In this revised third edition of the essential reference for clinical research coordinators (CRCs), Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, a glossary, and more. |
| clinical project management certification: The Role of Purchasers and Payers in the Clinical Research Enterprise Institute of Medicine, Board on Health Sciences Policy, Clinical Research Roundtable, 2002-06-14 In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective. |
| clinical project management certification: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| clinical project management certification: Professionalization of Project Management William L. Zwerman, Bill Zwerman, Janice Thomas, 2004 |
| clinical project management certification: Clinical Simulation Richard Kyle, W. Bosseau Murray, 2010-07-27 Simulation facilities are invaluable for training in medicine and clinical education, biomedical engineering and life sciences. They allow the practice of prevention, containment, treatment, and procedure in a risk-free setting. This book is a practical guide and reference to the latest technology, operations and opportunities presented by clinical simulation. It shows how to develop and make efficient use of resources, and provides hands-on information to those tasked with setting up and delivering simulation facilities for medical, clinical and related purposes, and the development and delivery of simulation-based education programs - A step-by-step manual to developing successful simulation programs - Shows how to design, construct, outfit and run simulation facilities for clinical education and research. - The Residency Review Committee of the US Accreditation Council on Graduate Medical Education has begun requiring residency programs to have simulation as an integral part of their training programs. |
| clinical project management certification: Designing Clinical Research Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman, 2011-11-30 Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly. |
| clinical project management certification: A National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, 2010-07-08 The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. |
| clinical project management certification: Emotional Intelligence for Project Managers Anthony Mersino, 2013-06-15 You’ve spent years gathering the technical intelligence you need for this challenging career--now separate yourself from the pack by increasing your emotional intelligence! As recent research has indicated that emotional intelligence (EI) now accounts for 70 to 80 percent of management success, there is no doubt that today’s successful project manager needs strong interpersonal skills and the ability to recognize emotional cues to lead their teams to success--the technical expertise the position depended on so greatly in the past simply isn’t enough anymore! Emotional Intelligence for Project Managers introduces you to all facets of EI and shows how emotions can be leveraged to meet project goals. Project managers strong in technical skills but needing help in the EI department will learn how to: Set the tone and direction for the project Communicate effectively Motivate, inspire, and engage their team Encourage flexibility and collaboration Deal productively with stress, criticism, and change Establish the kind of high morale that attracts top performers Now in its second edition, Emotional Intelligence for Project Managers includes several expanded sections on self-awareness and self-management, as well as a new chapter on using EI to lead Agile Teams and a close look at Servant Leadership. |
| clinical project management certification: The Basics of Achieving Professional Certification Willis H. Thomas, 2017-07-27 Professional certification has become a very popular topic and a significant number of individuals are making it a priority. Some people are torn on whether or not to obtain a certification to bolster their career. Others see the advantage of diversifying their professional portfolio and pursuing popular certifications in the areas of Project Management, Information Technology, Quality, or Human Resources. The Basics of Achieving Professional Certification: Enhancing Your Credentials provides clear-cut guidance on how to select a certification that is right for you and how you can continue to build your credentials in support of personal and professional goals. This easy-to-use guide can help anyone looking to achieve professional certification make informed decisions about the many options available. It can also help avoid the pitfalls of making the wrong choice as a result of being incorrectly informed. Examining the range of professional certifications offered by associations and organizations, it explains how to select the right professional certification and outlines best practices for completing the certification process. The book includes a CD that represents more than a year of development between resources in the U.S. and Europe. Packed with tools, it supplies permanent access to a suite of helpful training and development software, including:Library management system to track training material, books, and related items (created in MS Access)Learning management system to ensure training compliance (created in MS Access)A number of project management resources, including a comprehensive exam preparation programRoyalty free multimedia resources to add pizzazz to your e-learning programsForms, templates, and checklists to support training administrationTool |
| clinical project management certification: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
| clinical project management certification: Developing a Successful Clinical Research Program Cara East, 2018-08-08 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. |
| clinical project management certification: Leadership Competencies Of A Clinical Trial Project Manager John Petrera, 2024-06-17 Leadership competencies of a clinical trial project manager is unique in that this qualitative inquiry research project not only explores the specific top leadership competencies of project managers involved in pharmaceutical clinical trials, but the concepts reviewed in this book are applicable broad spectrum to multiple professional fields. The proposed leadership framework combines elements of leadership competencies, project management competencies, personal competencies, and includes a review of the leadership types from the traits theory of leadership. The leadership concepts described are universal and can be applied to improve any leader's abilities. While this book focuses on clinical trial project managers, the concepts and best practices apply to all PMs within pharmaceuticals or in any other field. The derived PM competency framework is transferrable to PMs in numerous industries and may also provide applicable guidance to others, regardless of their profession. Ultimately, the expansion of the PM triangle is a useful concept that many will find interesting. Additionally, personal competencies can improve personal effectiveness, achievements, and actions. This project identified 5 themes to include (a) CTPM experience and knowledge, (b) leadership competencies, (c) leadership types (styles), (d) personal competencies, and (e) project management competency development (PMCD). The 5 themes identified are all critical to understanding the perspectives obtained from the study participants regarding leadership competencies to maximize efficiencies of research and development. The results of this study can (a) potentially assist new CTPMs, (b) provide a refresher for CTPMs seeking improvement, (c) provide support for project managers in general, and (d) may assist hiring managers in determining the leadership skills to seek. The results from this study may support the project, program, and portfolio managers from various industries to better understand the leadership competencies and the overall framework that support project management. At the same time, these 5 themes, interpreted in the broadest terms, may be helpful to you! |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
