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| clinical trial management systems ctms: Siebel Clinical Blackbook , |
| clinical trial management systems ctms: 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 trial management systems ctms: Fundamentals of Decentralized Clinical Trials Anna H. Yang, |
| clinical trial management systems ctms: New Drug Approval Process Richard A. Guarino, Richard Guarino, 2016-04-19 The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step |
| clinical trial management systems ctms: Siebel Clinical Guide , |
| clinical trial management systems ctms: Exploring Complexity in Health: An Interdisciplinary Systems Approach A. Hoerbst, W.O. Hackl, N. de Keizer, 2016-09-22 The field of health is an increasingly complex and technical one; and an area in which a more multidisciplinary approach would undoubtedly be beneficial in many ways. This book presents papers from the conference ‘Health – Exploring Complexity: An Interdisciplinary Systems Approach’, held in Munich, Germany, from August 28th to September 2nd 2016. This joint conference unites the conferences of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), the German Society for Epidemiology (DGEpi), the International Epidemiological Association - European Region, and the European Federation for Medical Informatics (EFMI). These societies already have long-standing experience of integrating the disciplines of medical informatics, biometry, epidemiology and health data management. The book contains over 160 papers, and is divided into 14 sections covering subject areas such as: health and clinical information systems; eHealth and telemedicine; big data and advanced analytics; and evidence-based health informatics, evaluation and education, among many others. The book will be of value to all those working in the field of health and interested in finding new ways to enable the collaboration of different scientific disciplines and the establishment of comprehensive methodological approaches. |
| clinical trial management systems ctms: Global Clinical Trials Richard Chin, Menghis Bairu, 2011-05-06 This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA |
| clinical trial management systems ctms: A Picture is Worth a Thousand Tables Andreas Krause, Michael OConnell, 2012-12-12 This book is devoted to the graphics of patient data: good graphs enabling straight¬forward and intuitive interpretation, efficient creation, and straightforward interpretation. We focus on easy access to graphics of patient data: the intention is to show a large variety of graphs for different phases of drug development, together with a description of what the graph shows, what type of data it uses, and what options there are. The main aim is to provide inspiration in form of a “graphics cookbook.” Many graphs provide creative ideas about what can be done. The book is not intended to be technical. It introduces general principles of good visualization to make readers understand the concepts, but the main focus is on the creativity and usefulness: readers are enabled to browse through the book to get ideas of how their own data can be analyzed graphically. For additional information visit Editor’s companion website: http://www.elmo.ch/doc/life-science-graphics/ |
| clinical trial management systems ctms: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-04-20 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios |
| clinical trial management systems ctms: Siebel Functional Guide , |
| clinical trial management systems ctms: Essentials of Clinical Trials Dr. Nilesh Panchal, 2024-05-19 Essentials of Clinical Trials is an authoritative guide that offers a comprehensive exploration of the essential elements and advanced concepts in clinical research. This textbook delves into the fundamental principles of trial design, ethical considerations, data collection and management, and statistical methodologies, providing a clear and thorough understanding for students, researchers, and professionals. Additionally, it addresses contemporary topics such as adaptive trial designs, pragmatic trials, patient-reported outcomes, and precision medicine, highlighting the integration of big data and artificial intelligence. By combining practical insights with cutting-edge advancements, this book equips readers with the knowledge and tools needed to navigate the evolving landscape of clinical trials and contribute to the advancement of medical science. |
| clinical trial management systems ctms: Biomedical Informatics Edward H. Shortliffe, James J. Cimino, 2021-05-31 This 5th edition of this essential textbook continues to meet the growing demand of practitioners, researchers, educators, and students for a comprehensive introduction to key topics in biomedical informatics and the underlying scientific issues that sit at the intersection of biomedical science, patient care, public health and information technology (IT). Emphasizing the conceptual basis of the field rather than technical details, it provides the tools for study required for readers to comprehend, assess, and utilize biomedical informatics and health IT. It focuses on practical examples, a guide to additional literature, chapter summaries and a comprehensive glossary with concise definitions of recurring terms for self-study or classroom use. Biomedical Informatics: Computer Applications in Health Care and Biomedicine reflects the remarkable changes in both computing and health care that continue to occur and the exploding interest in the role that IT must play in care coordination and the melding of genomics with innovations in clinical practice and treatment. New and heavily revised chapters have been introduced on human-computer interaction, mHealth, personal health informatics and precision medicine, while the structure of the other chapters has undergone extensive revisions to reflect the developments in the area. The organization and philosophy remain unchanged, focusing on the science of information and knowledge management, and the role of computers and communications in modern biomedical research, health and health care. |
| clinical trial management systems ctms: Oxford Handbook of Clinical and Healthcare Research Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, Sarah Gibbings, 2016-03-03 The Oxford Handbook of Clinical and Healthcare Research is an evidence-based, succinct, and easy-to-use reference for the full range of clinical and healthcare research topics. Providing a wide breadth of essential knowledge, this comprehensive text takes the researcher through the steps from general good clinical practice in healthcare research to the process and management of research. This handbook includes clear instructions on the legislative and practical requirements of commissioning, conducting, analysing, and reporting research for those in clinical or healthcare practice, education, or training. Written with Good Clinical Practice (GCP) education in mind, it includes valuable information needed for the accredited certificates and diploma-level benchmark exams now commonly required by employers. This is a definitive text for all clinical and healthcare research students, as well as graduates with an interest in clinical and healthcare research. |
| clinical trial management systems ctms: Machine Learning and Systems Biology in Genomics and Health Shailza Singh, 2022-02-04 This book discusses the application of machine learning in genomics. Machine Learning offers ample opportunities for Big Data to be assimilated and comprehended effectively using different frameworks. Stratification, diagnosis, classification and survival predictions encompass the different health care regimes representing unique challenges for data pre-processing, model training, refinement of the systems with clinical implications. The book discusses different models for in-depth analysis of different conditions. Machine Learning techniques have revolutionized genomic analysis. Different chapters of the book describe the role of Artificial Intelligence in clinical and genomic diagnostics. It discusses how systems biology is exploited in identifying the genetic markers for drug discovery and disease identification. Myriad number of diseases whether be infectious, metabolic, cancer can be dealt in effectively which combines the different omics data for precision medicine. Major breakthroughs in the field would help reflect more new innovations which are at their pinnacle stage. This book is useful for researchers in the fields of genomics, genetics, computational biology and bioinformatics. |
| clinical trial management systems ctms: Dictionary of Pharmaceutical Medicine Gerhard Nahler, 2017-03-17 This dictionary defines various terms typically used in pharmaceutical medicine. A new, 4th edition includes adaptations of the text to the steadily increasing regulatory requirements, particularly in the area of genetics/gene therapy, product quality (e.g., protection against falsified medicines) and of product safety (pharmacovigilance). Further evolving areas that are covered by the 4th edition are typical “grey zones” (health effects often borderline to medicinal products) such as cosmetics and dietary supplements where misleading information is prohibited on one hand but where any health claims need formal authorisation on the other. These but also other areas are reviewed and presented in an updated and – if justified – in an enlarged form. |
| clinical trial management systems ctms: Clinical Data Manager - The Comprehensive Guide VIRUTI SHIVAN, In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, Clinical Data Manager: The Comprehensive Guide dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research. |
| clinical trial management systems ctms: Clinical Data Management Richard K. Rondel, Sheila A. Varley, Colin F. Webb, 2000-02-03 Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research. |
| clinical trial management systems ctms: Clinical and Translational Science David Robertson, Gordon H. Williams, 2009-03-02 Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science. - Clinical research is one of the fastest growing fields in private practice and academic medicine with practical biological, physiological, cellular, and therapeutic applications - Contributions from international leaders provide insight into background and future understanding for clinical and translational science - Provides the structure for complete instruction and guidance on the subject from fundamental principles, approaches and infrastructure to human genetics, human pharmacology, research in special populations, the societal context of human research, and the future of human research |
| clinical trial management systems ctms: Application of statistical tools in biomedical domain: An overview with help of software Editor, ISJMI, 2018-03-30 This book is an edited book from the papers of International Journal of Statistics and Medical Informatics authored by Editor, International of Statistics and Medical Informatics. It covers topics such as systematic review and meta-analysis, factor analysis, structural equation modelling and quantile regression in the field of biomedical domain. It also provides insight into the post hoc comparison, clinical trail data management and natural language processing |
| clinical trial management systems ctms: Textbook of Computer Aided Drug Development Dr. Dinesh Kaushik, Mr. Kunal Kaushik, 2024-11-16 This book delves into the utilization of computer-assisted techniques in the exploration, design, optimization, and production of novel pharmaceutical formulations and drug delivery systems, with a focus on their efficacy and safety. It covers computational methods, statistical and molecular modeling, all aimed at facilitating the development and safe administration of drugs in humans. The integration of Quality by Design (QbD), Design of Experiments (DoE), artificial intelligence, and in silico pharmacokinetic assessment/simulation is greatly facilitated by commercial software and expert systems, all of which are thoroughly examined in this title, accompanied by examples drawn from recent research. Furthermore, this book bridges the gap between pharmaceutics and molecular modeling across various scales (micro, meso, and macro) by addressing topics such as advancements in computer-aided Drug Design (CADD), drug-polymer interactions in drug delivery systems, molecular modeling of nanoparticles, and the intersection of pharmaceutics with bioinformatics. Abundant examples, case studies, and illustrations showcasing the applications of computers in formulation design and characterization are provided. Additionally, the book includes concise reviews of software, databases, and expert systems, further piquing the interest of readers in novel applications in formulation development and drug delivery. |
| clinical trial management systems ctms: The Fundamentals of Clinical Research P. Michael Dubinsky, Karen A. Henry, 2022-01-26 This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources |
| clinical trial management systems ctms: CRO – Contract Research Organization: How Drug Research is Evolving Jakob Miera, 2014-02-01 This book deals in general with mergers & acquisitions in the CRO industry, and more specifically with reasons for M&A, success factors during the M&A process, and why M&A can fail in the Contract Research Organization industry. The pharmaceutical industry faces increasing obstacles in respect to the development and introduction of new medications. That has to do with stricter requirements for admission and sharper controls by authorities. Today, the research and development of a new drug can easily consume more than $800 million and lasting between 10 and 15 years. Due to these facts pharmaceutical companies are looking for an alternative in the drug development process. A popular alternative is the outsourcing or in-house working with Contract Research Organizations (CRO). CRO are specialized in coordination and monitoring of drug development activities. The size of the CRO market in 2012 was around $32 billion and had an estimated market growth of around 9 – 12% for 2013. Increased outsourcing and allocation of R&D money towards CRO reflects a driving force for prospective growth. Contract Research Organizations consider mergers & acquisitions as a vital solution to achieve their objectives. |
| clinical trial management systems ctms: A to Z of Pharmacovigilance Dr Azmath Unnisa Begum, VEERENDRA CHAURASIA, Rahathunnisa Begum, Dr. Sarthak Bhattacharya, Meesa Madhavi, 2024-04-23 A to Z of Pharmacovigilance serves as your comprehensive companion to understanding the science and practice of drug safety, adhering to the latest syllabus prescribed by the Pharmacy Council of India (BP 805 T). This book empowers pharmacy students and professionals alike to navigate the ever-evolving world of pharmacovigilance. A to Z of Pharmacovigilance is an indispensable resource for Pharmacy students pursuing BP 805 T curriculumand for pharmacy professionals seeking to enhance their pharmacovigilance knowledge and also for anyone who is interested in understanding the importance of drug safety, and want to grasp the global and Indian regulatory framework governing pharmacovigilance activities. |
| clinical trial management systems ctms: Clinical Trials Timothy M. Pawlik, Julie A. Sosa, 2020-03-10 This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons. |
| clinical trial management systems ctms: TEXTBOOK OF COMPUTER AIDED DRUG DEVELOPMENT Dr. Surya Devarakonda, Dr. Purma Aravinda Reddy , Dr. Divya Yada , Ms. Bansi H. Zalavadia , Dr. Reeta Sethi, 2024-09-02 This book explores the use of computer-assisted techniques in the discovery, design, optimization, and production of innovative pharmaceutical formulations and drug delivery systems, with an emphasis on their effectiveness and safety. It discusses computational methods, statistical and molecular modeling, all aimed at advancing the development and safe administration of drugs in humans. The book thoroughly examines the integration of Quality by Design (QbD), Design of Experiments (DoE), artificial intelligence, and in silico pharmacokinetic assessment/simulation, facilitated by commercial software and expert systems, and includes examples from recent research. Computer-aided Pharmaceutics and Drug Delivery serves as a comprehensive reference for the latest scholarly updates on emerging developments in computer-assisted techniques for drug design and development. It is intended for pharmacists, medical practitioners, students, and researchers seeking authoritative insights into this evolving field. |
| clinical trial management systems ctms: Biomedical Informatics for Cancer Research Michael F. Ochs, John T. Casagrande, Ramana V. Davuluri, 2010-04-06 view, showing that multiple molecular pathways must be affected for cancer to develop, but with different specific proteins in each pathway mutated or differentially expressed in a given tumor (The Cancer Genome Atlas Research Network 2008; Parsons et al. 2008). Different studies demonstrated that while widespread mutations exist in cancer, not all mutations drive cancer development (Lin et al. 2007). This suggests a need to target only a deleterious subset of aberrant proteins, since any tre- ment must aim to improve health to justify its potential side effects. Treatment for cancer must become highly individualized, focusing on the specific aberrant driver proteins in an individual. This drives a need for informatics in cancer far beyond the need in other diseases. For instance, routine treatment with statins has become widespread for minimizing heart disease, with most patients responding to standard doses (Wilt et al. 2004). In contrast, standard treatment for cancer must become tailored to the molecular phenotype of an individual tumor, with each patient receiving a different combination of therapeutics aimed at the specific aberrant proteins driving the cancer. Tracking the aberrations that drive cancers, identifying biomarkers unique to each individual for molecular-level di- nosis and treatment response, monitoring adverse events and complex dosing schedules, and providing annotated molecular data for ongoing research to improve treatments comprise a major biomedical informatics need. |
| clinical trial management systems ctms: Managing Innovation Inside Universities Randolph Hall, |
| clinical trial management systems ctms: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference. |
| clinical trial management systems ctms: Project Management for Drug Developers Joseph P. Stalder, 2022-12-29 Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses. |
| clinical trial management systems ctms: Practical Considerations for Adaptive Trial Design and Implementation Weili He, José Pinheiro, Olga M. Kuznetsova, 2014-10-15 This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation. |
| clinical trial management systems ctms: Neuroscience Trials of the Future National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2016-11-07 On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future. |
| clinical trial management systems ctms: P5 eHealth: An Agenda for the Health Technologies of the Future Gabriella Pravettoni, Stefano Triberti, 2019-11-29 This open access volume focuses on the development of a P5 eHealth, or better, a methodological resource for developing the health technologies of the future, based on patients’ personal characteristics and needs as the fundamental guidelines for design. It provides practical guidelines and evidence based examples on how to design, implement, use and elevate new technologies for healthcare to support the management of incurable, chronic conditions. The volume further discusses the criticalities of eHealth, why it is difficult to employ eHealth from an organizational point of view or why patients do not always accept the technology, and how eHealth interventions can be improved in the future. By dealing with the state-of-the-art in eHealth technologies, this volume is of great interest to researchers in the field of physical and mental healthcare, psychologists, stakeholders and policymakers as well as technology developers working in the healthcare sector. |
| clinical trial management systems ctms: Writing and Managing SOPs for GCP Susanne Prokscha, 2015-07-29 This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management. |
| clinical trial management systems ctms: Clinical Trials Audit Preparation Vera Mihajlovic-Madzarevic, 2010-09-29 A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development |
| clinical trial management systems ctms: Good Informatics Practices (GIP) Module: Data Management Robert Barr, Vizma Carver, Kim Green, Nishant Jain, Anthony Omosule, Steven Owens, Mark Vilicich MS, CSM, Ford Winslow, Nigel Wright, |
| clinical trial management systems ctms: Digital Health Eric D. Perakslis, Martin Stanley, 2021 Drawing on expert interviews, original research, and personal storytelling, Digital Health explores the theory, science, and applications behind the uses of emerging digital technologies in healthcare. |
| clinical trial management systems ctms: Health Informatics: Practical Guide for Healthcare and Information Technology Professionals (Sixth Edition) Robert E. Hoyt, Ann K. Yoshihashi, 2014 Health Informatics (HI) focuses on the application of Information Technology (IT) to the field of medicine to improve individual and population healthcare delivery, education and research. This extensively updated fifth edition reflects the current knowledge in Health Informatics and provides learning objectives, key points, case studies and references. |
| clinical trial management systems ctms: Patient-Focused Network Integration in BioPharma Robert Handfield, 2018-10-08 The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure. A wake-up call to all sectors of the healthcare value chain, Patient-Focused Network Integration in BioPharma: Strategic Imperatives for the Years Ahead explores patient-focused network integration as quite possibly the only way for organizational evolution to occur. The book discusses how to align enterprises with the patient at the center. It details the historical context of the biopharmaceutical value chain and the current set of challenges facing the industry, and then details the author’s unique and sustainable agenda for change. The book traces the critical but often ignored relationships between hospitals, insurance companies, biopharma manufacturers, government regulators, and clinical scientists. For too long, these parties have been operating in a void, without recognizing the interconnectedness of their objectives, even though these objectives are often competing and misaligned. This book points out the gaps that exist and develops a set of recommendations regarding disease treatments, clinical development of new products, and collaboration between these players that can result in a sustainable solution to the healthcare mess. Each chapter can be viewed as an independent essay, in that it deals with a specific dimension of the healthcare value chain. However, together they provide an integrated discussion on how to begin the task of creating an integrated value chain network for healthcare. The book begins with the patient, and then works its way back down the value chain, all the way to the drug development and clinical trials stage of the value chain. The common thread throughout the chapters is the emphasis on collaboration, strategic alignment, and a focus on delivering value to the end patient. Very simply, all parties in the healthcare value chain network must align their strategic planning to derive innovation solutions. It is only through true collaboration and aligned thinking that the parties in the drug development, distribution, insurance payors, and hospital provider network can deal with the incredible complexity and massive challenges that face the industry. The book provides a compelling maturity model that enables readers to gauge the level of network integration their enterprise is at today, and where they need to move in the future. |
| clinical trial management systems ctms: Circulating Tumor Cells Richard J. Cote, Evi Lianidou, 2023-08-01 It is well recognized that blood could be the optimal site for evaluating cancer, allowing easy and repeated access for determining prognosis, establishing molecular targets, evaluating the efficacy of therapy, detecting the earliest signs of recurrence, and even detecting cancer at its earliest and most curable stages. The analysis of cancer through blood samples is now known as the liquid biopsy and has been a rich source of research and clinical application. There has been an explosion of interest and progress in liquid biopsy technologies since the first edition of this book. The second edition will expand its focus to now include not only circulating tumor cells (CTC), but also other emerging aspects of the liquid biopsy, including circulating tumor DNA and methylated DNA (ctDNA, ct meDNA), ctRNA, ct miRNA, circulating tumor proteins (and other) biomarkers and circulating tumor derived exosomes (ctExosomes). CTC play a central role in tumor dissemination and metastasis, and have been established as an important evaluative and research tool in advanced cancer, and potentially important in early stage disease. CTC defines tumor cells circulating in blood, while Disseminated Tumor Cells (DTC) refers to tumor cells identified in bone marrow. CTC/DTC are extremely rare events, even in late stage cancer, and their detection has presented enormous technical challenges, with the emergence of multiple technologies developed to address these challenges, including enrichment, identification and sophisticated analytical techniques to evaluate CTC and other cells in circulation that may also be important in the biology of metastasis. As foundational as CTC/DTC has been, the field of liquid biopsy has expanded well beyond these analytes. The relevance of circulating nucleic acids derived from tumor cells has quickly progressed from research to the clinic. There are now well established clinical applications for using ctDNA/RNA to determine therapeutic targets, follow disease progression and detect cancer recurrence long before routine clinical methods. One of the most exciting new areas of work is the possibility of using these circulating tumor derived nucleic acids to detect cancer at its earliest and potentially most curable stages. Another new and burgeoning area is the detection and analysis of ctExosomes. These highly abundant particles which are actively secreted from tumor (and indeed all) cells represent a novel way to detect and define multiple analytes of importance, including proteins, DNA and meDNA, RNA, miRNA, and other cell components that are protected and preserved in these compact structures. This second edition of Circulating Tumor Cells: Advances in Liquid Biopsy Technologies is entirely new and brings together leaders and innovators in the field of liquid biopsy, including basic and molecular biologists, chemists, engineers, statisticians, experts in tumor banking, test developers, research administrators and clinicians. A special feature of this book is that it includes chapters from the members of the US National Cancer Institute Liquid Biopsy Consortium. This edition also includes many of the participants of the latest international meeting on the Advances in Circulating Tumor Cells (ACTC) which is held in Greece every two years and gathers the most important liquid biopsy investigators from around the world. Thus, this edition represents the most comprehensive and up-to-date resource for those who want to further explore the exciting field of CTC and other liquid biopsy technologies. The new edition will be useful to a wide audience including scientists studying metastasis, cancer researchers, translational scientists, oncologic surgeons, medical oncologists, members of the biopharmaceutical industry, and graduate and undergraduate students studying cancer biology. |
| clinical trial management systems ctms: Outsourcing Clinical Development Jane Baguley, 2016-05-13 The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners. |
Clinical Trial Management System - IQVIA
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Whether you are implementing a clinical trial management system (CTMS) for the first time or replacing your legacy CTMS, the process necessitates intensive detail and planning.
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Clinical Trial Management System (CTMS) for Sites, formally known as Merge Clinical Trial Management System for Investigators, is a platform used by institutions conducting research …
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protocol and accrual related information in the Clinical Trial Management System (CTMS). SCOPE: This SOP applies all departments and trials performing cancer-related clinical …
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IQVIA’s deep expertise in clinical trial operations, IQVIA Technologies Clinical Trial Management System improves subject safety, data quality and operational efficiency, …
Siebel Clinical Trial Management System Guide - Oracle
Features of Siebel Clinical Trial Management System ..... 3 Product Modules and Options for Siebel Clinical Trial System ..... 4 3Setting Up Siebel Clinical 7
Ennov Product Brief - CTMS
Ennov CTMS is a true Business Process Management (BPM) solution that automates, controls and measures your clinical business process. Workflow, data and documents are …
CTMS IMPLEMENTATION CHECKLIST - Trial Interactive
Whether you are implementing a clinical trial management system (CTMS) for the first time or replacing your legacy CTMS, the process necessitates intensive detail and planning.
IBM Clinical Trial Management System for Sites helps you streamline ...
Clinical Trial Management System (CTMS) for Sites, formally known as Merge Clinical Trial Management System for Investigators, is a platform used by institutions conducting …
