derhan/semantic-scholar-manajemen-proyek huggingface dataset:
[Recent progress and challenges in investigator-driven clinical development of novel drugs and medical devices at the University of Tokyo Hospital].
Authors: Y. Arakawa
Year: 2013

At the University of Tokyo Hospital, investigator-driven clinical development of novel drugs and medical devices is mainly supported by the Translational Research Center and Clinical Research Support Center. The former supports non-clinical research and the preparation of test materials and the latter supports clinical trials. The Clinical Research Support Center was established in 2010 by the reorganization of the former Clinical Research Center, which was established in 2001. The center adopted International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) as a standard guideline for clinical trials and prepared standard operation procedures and templates for protocols and informed consent documents in 2001 and, thereafter, provided consultation services to researchers for protocol development. In 2010, the service was extended to project management, data management and monitoring to support the credibility of clinical trials. In 2011, The University of Tokyo Hospital was selected by the government as a base for the early and exploratory clinical development of drugs in the fields of psychological and neurological diseases. For this purpose, a phase 1 unit for early phase clinical pharmacology trials is now being built. The center provides training courses for clinical research coordinators and hold seminars for clinical researchers; however, the biggest challenge remains the education and training of medical students who will lead clinical trials in the future.
Analysis of the principles and functions of the project approach to enterprise management
Authors: Е.В. Бокарева; А.А. Силаева; А.Г. Панова; Н.В. Дмитриева; Т.Н. Лустина; Н.А. Чхиквадзе
Year: 2021

В текущее время сложно назвать наиболее важную и много охватывающую сферу деятельности, чем управление, или менеджмент, от него в большей мере зависит эффективность производства в целом. В настоящее время управление проектами применяется все чаще и объёмнее, каждое управление имеет в своей основе управленческие решения, и постановку цели. На сегодняшний день в нашем государстве действует рыночная экономика, а это означает что на рынке много различных организаций. Между организациями существует конкуренция. Именно по этому организации вынуждены повышать эффективность своей работы. Повышение эффективности позволяет повысить конкурентоспособность организаций. В свою очередь повышение конкурентно способность повышает прибыль и укрепляет позиции организации на рынке. Исследование в области повышения эффективности деятельности организации можно назвать постоянно актуальным. Их необходимость возникает каждый раз при смене экономической ситуации или при появлении более конкурентоспособных организаций.
 At the current time, it is difficult to name the most important and much covering field of activity than management, or management, the efficiency of production as a whole depends on it to a greater extent. Currently, project management is used more and more often, each department is based on management decisions and goal setting. Today in our state there is a market economy, which means that there are many different organizations on the market. There is competition between organizations. This is why organizations are forced to improve the efficiency of their work. Improving efficiency can improve the competitiveness of organizations. In turn, increased competitiveness increases profits and strengthens the organization's position in the market. Research in the field of improving the efficiency of the organization can be called constantly relevant. Their need arises every time the economic situation changes or when more competitive organizations appear.
Managing layers of risk: Uncertainty in large development programs combining agile software development and traditional project management
Authors: Torgeir Dingsøyr; Yvan Petit
Year: 2021

Software development projects have a track record of schedule and cost overruns, and have often faced challenges with delivering expected quality (Flyvbjerg & Budzier, 2011). In the nineties many expressed concern about software projects and used the word “crisis” (Kraut & Streeter, 1995). Consequently, project management professional associations and some authors have proposed that software development projects should adopt and implement the traditional risk management approaches as a contributor to success (Dey et al., 2007). This is quite natural since risk management has been considered one of the core knowledge areas in project management for many decades. Literature abounds in this field (Chapman & Ward, 2003; Jaafari, 2001; Johansen et al., 2019; Kendrick, 2015; Persson et al., 2009; Project Management Institute, 2019; Raz et al., 2002) and most general project management books include at least a section on risk management (Andersen, 2008; Dinsmore & Cabanis-Brewin, 2014; Gray & Larson, 2014; Kerzner, 2017; Nicholas, 2017). Risk management has also been shown to bring a number of benefits such as identification of favourable alternative courses of action, reduced surprises, and provided more precise estimates (Bannerman, 2008). However, recent research has also shown that these practices are not widely used in software development projects (Bannerman, 2008; Odzaly & Des Greer, 2014). Risk Management is covered in the PMBOK Guide (Project Management Institute, 2017) which defines a project risk as: “an uncertain event or condition that, if it occurs, has a positive or negative effect on a project objective” (p. 720) with processes for risk identification, risk categorization, risk qualitative and quantitative analysis, plan risk responses, monitor risks and implement risk response. Both the Project Management Institute (PMI) and Association for Project Management (APM) define a risk as an uncertain “event” which might have positive effects (opportunities) or negative effects (threats) (Association for Project Management, 2008). In general, however, project managers and the literature tend to focus on threats rather than on opportunities (Johansen, 2015). One of the most used textbooks in software engineering, for example, defines risks as “something you ́d prefer not to happen” (Sommerville, 2016). Several techniques have been developed to assess the probability of occurrence and the potential
Incorporation of resource reliability into critical chain project management buffer sizing
Authors: Seyed Ashkan Zarghami; I. Gunawan; G. C. Zubielqui; Bassam Baroudi
Year: 2019

The methods presently used for buffer sizing of Critical Chain Project Management (CCPM) have lagged far behind capturing the stochastic nature of resource acquisition in real-world projects. The work described herein represents a new step towards the sizing of buffers for CCPM by developing a probabilistic measure obtained through a reliability analysis of project resources. The proposed method treats the resource availability as a random variable in project scheduling, meaning that each resource has a distribution of possible values of availability. In this method, buffer size is determined by assigning a scaling factor to the standard deviation of a chain. This scaling factor is the function of the reliability of available resources assigned to the chain activities, taking into account the likelihood of timely completion of the chain given the reliability of each individual resource. Sensitivity analysis, as well as the comparison of the proposed method with the conventional buffer sizing methods, reveal the effectiveness of the new method.
An Ontology-based Knowledge Acquisition for PDM
Authors: Wisarat Srisungnoen; W. Vatanawood
Year: 2018

In the present, there are numerous project management software packages used to serve the complex scheduling tasks in a project plan including different groups of people and resources. Most of the tools apply Precedence Diagram Method (PDM) to visualize the activities and their dependencies among various project activities but these tools do not provide semantic representation. Thus, it still requires an implicit knowledge of project managers to analyze and manage scheduling tasks. Ontology could be used to represent the structure of a domain by means of defining concepts and properties that relate them. Accordingly, in this paper, we propose an ontology-based approach for building PDM ontology using OWL and construct SWRL reasoning to infer new knowledge from existing one.
Business Escalation Management: A Case Study - Resolution of a Business Relationship Deterrent
Authors: K. Pradeepkumar; R. Tom
Year: 2012

Business Escalation Management framework was conceptualized as a governance and issue resolution channel for complex business relationship scenarios demanding immediate attention from the management. Escalation in a business engagement scenario is often a deterrent to the overall health of the relationship. In organizational business units, there are possibilities of misalignment between the customer's strategic objectives and developmental execution mode to effectively identify, manage and execute the projects in line with the targeted goals. There is often a chasm between business objectives and their fulfillment through project management activities. Due to the amount of complexity required to meet customer demands for performance, features and customization, possibilities of conflicts across concerned stakeholders is high. In corporate world, escalation situation is likely to be a competition in risk-taking or at least resolve, and a matching of local resources, in some form of limited conflict between two sides, provided that the other side did not negate the increase by increasing its own efforts. This framework is defined and institutionalized as a diagnostic tool for the management of conflicts which can otherwise destroy the relationship beyond repair. This paper describes various features of the framework, different phases and procedural steps that lead to the resolution of the escalation and details of a case study where this framework was deployed.
Construction of Evaluation Indicator System for Acceptance of Soft Science and Technology Projects in Tobacco Industry based on OKR
Authors: Ming Wei; Ziyi Gao; Yunpeng Mei; Chao Chen; Yimin Wang
Year: 2024

Soft science and technology projects are one of the basic organizational forms of scientific and technological activities, being the process of generating, accumulating, and applying new knowledge.The evaluation of science and technology project is a key stage in the process of science and technology project management. In the new development stage, it is urgent to speed up the formation of a comprehensive innovative management system. Constructing an acceptance evaluation indicator system of soft science and technology projects is an important link to deepen the management of science and technology projects. Based on the OKR (Objectives and Key Results) method and combined with the characteristics of soft science projects, the acceptance evaluation objectives such as schedule, quality, cost, and team management are proposed. The evaluation objectives are transformed into quantifiable key outcome indicators, and a system of evaluation indicators for soft science and technology project acceptance in tobacco industry is constructed. Field research is carried out in the tobacco industry, using the entropy value method to assign weights to the evaluation indicators, with a view to providing a decision-making basis for the acceptance evaluation of the scientific and technological project management departments, and accelerating the formation of new quality productivity in the tobacco industry.
THE USE OF AGILE METHODOLOGY IN THE CONTEXT OF VARIOUS TYPES OF BUSINESS ACTIVITIES
Authors: Maryana Gvozd; Artur-Maxym Olynets; Roman Ostashchuk
Year: 2024

In the context of modern business, which requires a quick response to changes, improved communication and project management, the use of Agile methodologies becomes extremely relevant and an important factor for achieving success and competitive advantage of enterprises. The purpose of the article is to study the peculiarities of using Agile methodologies in the context of various types of business activities. Using a comparative analysis, the article considers the directions of implementation of Agile methodologies for such types of business activities as production of products, execution of works, provision of services, trade activities and commercial mediation. The study notes the role of Agile methodologies in improving the efficiency of work processes, increasing flexibility in project management and increasing responsiveness to changes in market requirements. The main differences in the application of Agile methodologies in the organization of production processes compared to the provision of services are highlighted, emphasizing the flexibility of Agile methodologies in adapting to various requirements and needs of business activities. It is noted that the Agile concept is effective in process activities, which is confirmed by the example of a quick service cafe. The suitability of Agile methodologies for the development of projects in a wide range of industries, including marketing, advertising and PR activities, is substantiated, which indicates the universality of the approach and its successful use in areas that require quick adaptation to changing market conditions and a high level of communication with clients. The effectiveness of the use of Agile methodologies in various sectors of economic activity from the point of view of project management, development of products and services, as well as in response to changes in market conditions is shown. This topic is important for understanding and promoting the benefits of Agile methodologies in modern business, stimulating further research and implementation of these practices to achieve competitive advantages in various industries. The results of the study will contribute to the improvement of the organization of work processes in various industries and areas of business, allowing enterprises to increase the speed of reaction to market changes and customer requirements.
A Preliminary Investigation of Exploration-Oriented, Learning Behaviors for Managing Project Quality
Authors: B. Herod; J. Kovach
Year: 2015

Customers are typically dissatisfied when projects fail to meet requirements and/or expectations. While effectively managing projects requires balancing competing constraints, quality is one aspect of project management that has not been widely explored. To address this issue, this research investigated the characteristics of learning/exploration used to support managing project quality. This qualitative study used semi-structured interviews with information technology IT project managers to identify learning/exploration-oriented approaches currently used in project-based environments. Analysis of the data obtained through interviews identified characteristics of learning/exploration used in projects and these findings were validated through a focus group with additional IT project managers. Based on this research, an approach is proposed that provides specific insights for project managers about using exploratory practices. When coupled with traditional project quality management processes, these learning/exploratory activities may help to enhance ambidexterity within project-based organizations and improve project quality outcomes.
Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience
Authors: Abhishek A. Solanki; Kevin Zheng; A. Skipworth; Lisa M Robin; Ryan F. Leparski; Elizabeth Henry; Matthew B. Rettig; Joseph K. Salama; Timothy Ritter; Jeffrey A Jones; M. Quek; Michael Chang; Alec M. Block; James S. Welsh; Aryavarta Kumar; Hann-Hsiang Chao; Albert C Chen; Ronald Shapiro; Rhonda L Bitting; Robert Kwon; William Stross; Lindsay Puckett; Yu-Ning Wong; N. Nickols; Kimberly Carlson
Year: 2024

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)—the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.
Communication Channels in Brazilian Software Projects: An Analysis based on Case Study
Authors: Leandro Zocaratto Rezende; E. Prado; Alexandre Grotta
Year: 2021

: Technology project management is challenging. However, there are few works in the literature related to communication channels (CC) and project success. Therefore, this research aims to analyze the influence of communication channels on the short and medium-term success of software development projects in a Brazilian enterprise. This research is based on a literature review about communication channels and project success. The research has a qualitative and descriptive approach and used an ex-post-facto strategy. Ten software development project management professionals were interviewed at a large banking institution in the first half of 2019. This research confirmed a positive association between CC and software project success when considering efficiency, impact to the customer, and project staff. Besides, we also identified the two most relevant CC for the context studied and identified a CC not mentioned in the literature.
Implementation of a Six-Layer Smart Factory Architecture with Special Focus on Transdisciplinary Engineering Education
Authors: B. J. Ralph; Marcel Sorger; Benjamin Schödinger; Hans-Jörg Schmölzer; Karin Hartl; M. Stockinger
Year: 2021

Smart factories are an integral element of the manufacturing infrastructure in the context of the fourth industrial revolution. Nevertheless, there is frequently a deficiency of adequate training facilities for future engineering experts in the academic environment. For this reason, this paper describes the development and implementation of two different layer architectures for the metal processing environment. The first architecture is based on low-cost but resilient devices, allowing interested parties to work with mostly open-source interfaces and standard back-end programming environments. Additionally, one proprietary and two open-source graphical user interfaces (GUIs) were developed. Those interfaces can be adapted front-end as well as back-end, ensuring a holistic comprehension of their capabilities and limits. As a result, a six-layer architecture, from digitization to an interactive project management tool, was designed and implemented in the practical workflow at the academic institution. To take the complexity of thermo-mechanical processing in the metal processing field into account, an alternative layer, connected with the thermo-mechanical treatment simulator Gleeble 3800, was designed. This framework is capable of transferring sensor data with high frequency, enabling data collection for the numerical simulation of complex material behavior under high temperature processing. Finally, the possibility of connecting both systems by using open-source software packages is demonstrated.
Differentiation criteria for strategic and non-strategic project and programmes
Authors: Apenko Svetlana Nikolaevna; Klimenko Oxana Alekseevna
Year: 2017

While managing the project it is important to realize the type and scale of it as well as the influence on the company's strategic goals. It could be useful to know what projects, por-grammes or portfolios are strategic and what of them are not. It is helpful for project managers to know the certain criteria for distinguishing the project, porgrammes and portfolios regarding their strategic (or non-strategic) nature. In this paper the authors try to develop the common basis view on the strategic and non-strategic project and suggest a number of criteria that could be used by the project managers, porgrammes managers and portfolio directors as well as other stakeholders. Research and justification methods of main conclusions were chosen: qualitative analysis of professional standards in project management on subject to references and disclosure of the question of strategy and strategic projects; a case study of strategic and non-strategic projects; expert survey on the criteria of differences in strategic and non-strategic projects. The authors identified criteria for the differences in strategic and non-strategic projects, prove conclusively that these fundamentally different types of projects require different methods, techniques and tools of management. The first step should be to identify the type of project in terms of its strategic vision.
Research on the Influence of Shashi Decreasing of Low Water Level on the Yangtze River to Han River Project
Authors: Yong Hua; Hongmei Yu; Shuai Zhou; Wei Shi; Xiaomeng Zhang
Year: 2024

Since the impoundment of the Three Gorges Reservoir (TGR), the water and sediment conditions of Shashi Reach have changed significantly, and the water levels, especially the low water levels have decreased obviously. The intake of the Yangtze River to Han River Project is located in the Shashi Reach, and the Shashi low water levels affect the project channel inlet flow condition, which makes the water intake demand barely guaranteed during the dry season. Hydrological analysis methods are adopted to analyze the changing rule of water and sediment processes and the decline trend of low water level in the Shashi Reach in the past 50 years. The influence and strategies of Shashi low water level decreasing on the Yangtze River to Han River Project are studied according to the channel diversion volume of the project, which can provide technical support for engineering operation, maintenance, and renovation for the project management.