...Research question Organizational culture can be defined by several themes that influence the operations and execution of personal and professional goals. Leadership, national culture, organizational effectiveness and the overall values upheld throughout a group diversify the experience of all those involved (Schnedier et al., 2012). These variables are important in addressing the complex nature of institutional operations as well as the personal relationships that may transpire within a group setting. The stability with which an organizational culture operates is based on these elements and therefore lend valuable evidence to the cross cultural context of entrepreneurship and business development. This study will investigate the differences in gender roles and accountability throughout organizational culture. Based on these defining themes, it will be possible to identify key differences in gender placement throughout management and other positions of hierarchical interest within an organization. In demonstrating the value of infrastructure supporting organizational culture it will be valuable to discuss the social relationships and formation of culture across genders in a professional atmosphere. Since many elements regarding position, authority and general status can be ascertained through behaviors and specific cultural elements, it is necessary for the field to particularly define gender differences and similarities in a variety of contexts. The differences in leadership...
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...Agencies 1 World Wide Regulatory Agencies Amy Lynn Wooldridge HCA375: Continuous Quality Monitoring & Accreditation Instructor: Heather Ables December 4, 2011 Agencies 2 “Clinical Contract Research Organizations (CROs) provide a range of services from consulting to labor- intensive tasks such as data processing”. (Kaluzny & McLaughlin, 2006, p.318) The majority of CRO growth is accounted for by pharmaceutical & biotechnology industries. The contract research organization is contracted by a sponsor or client to perform several functions and duties related to clinical trials. (Kaluzny & McLaughlin, 2006, p. 319) The clinical trials are designed to obtain regulatory approval to market new pharmaceutical or biotechnology products. (Kaluzny & McLaughlin, 2006, p. 319) The services they perform for such clients as pharmaceutical companies include: “consulting and advice related to the design of drug development programs to labor-intensive services that are part of the drug development process; these include clinical monitoring of investigational sites, data management and statistical analysis, and presentations of regulatory submissions for review by regulatory agencies such as the U.S. Food and Drug Administration”. (Kaluzny & McLaughlin, 2006, p. 319) The FDA in the United States clearly mandate practices to protect the public’s health by implementing laws, regulations, and guidelines that provide oversight of the drug development...
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...Introduction Clinical trials, for any pharmaceutical company are significant, as they serve as the back bone in Research and development of new medicines and their standardization for the advantage of human population. In developed countries the conduct of clinical trials in more transparent and heavily regulated. However, the conduct of clinical trials in India come with lot of risks, as a lot of people are uneducated, no rules of compliance by the government. India was considered as the economical and feasible place to conduct these clinical trials, as the laws pertaining for the same were not stringent. Clinical Trials: A clinical trial is a scientific investigation to evaluate the effect of new drugs or vaccines other than health interventions, by administering these to human volunteers. They are generally bio medical or health-related research studies in human beings that follow a pre-defined protocol. In 2005 amendments were made on Drugs and Cosmetics Act, 1945, which allowed big companies to start their clinical trials in India. After that, there are number of incidents resulting in death of people participating in such clinical trials, particularly women, aged and even mentally challenged people, across the country. Due to this, the Drugs and Cosmetics Act Amendment Bill 2013 was brought forth in order to strengthen the drug regulatory system and create a central authority for managing drug and medical device approval. The non-conducive climate for clinical trials...
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...reflect high operating cost. The high cost of getting this product to the market include clinical trials, patent approval and FDA approval; industry-financed studies claimed $114 million 1987, later went up to $231 million, $403 million, and then $2.1 billion in 2006 for FDA approval, patent approval and clinical trials. Oligopolies in most cases tend to go multinational which is largely associated with todays’ drug companies. In terms of research and development, I will say it is the backbone of the pharmaceutical industry which makes it very important. I will want to focus on Pfizer one of the big names in this industry. Pfizer’s Global Research and Development is probably the group that the company takes the most pride in for obvious reasons. If we take a broader look at R&D we will see the role and importance of Contract Research Organizations (CROs). CROs account for about 20 percent of drug companies' traditional development business, according to Graham Hughes, a founder and scientific director of Technomark Consulting Services, a London-based firm that has specialized in CROs since...
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...Social research is an important part of the organization study. It seems that not only the researchers but also people who read the research reports may gain quantities of benefits from the research. People may depend on social research in order to deeply understand an organization or study in a phenomenon. There’s little doubt the researcher has to pay numerous attentions on research methods, research process and research outcome presenting. However, research ethics, which is an invisible thing during the research, cannot be neglected as well. Since participants of the research have sacrificed their time and energy for the research, it seems that they deserve paybacks. Research ethics, which is crucial when taking out researches, can be a basic part of the paybacks. This essay sets out to examine several ethics concerns when doing social researches. In order to make the essay clear and easy to understand, examples and further explanations will be carried out. It is generally held that basic polite and respect is essential in social research. Participating in a research is more likely to be a voluntary behavior. As a result, the researcher needs to respect the desire of the participants. On the one hand, it is supported that there is no right for researchers to force people into a research. In the reality, there are companies whose director frequently asks the employees to try out the new products. This can be seen as an improper behavior. On the other hand, to people who have...
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...There are many organizations out there that do a lot for people out of the good in their own heart, while at the same time asking for almost nothing in return. Nonprofit organizations, specifically, have many different causes which might seem to clearly differentiate one from the other (things such as contributing to a community’s resources, activities available in a town, medical aid, finding people homes, etc.). All these groups alike, however, have one outstandingly prominent goal: to take action and help others. If I was to volunteer for any nonprofit organization, especially from those that I’m already familiar with and know about, I would most certainly volunteer for helping Friends of Libraries, Inc.. The main reasons for this are simple; I personally really enjoy reading and would like to be able to promote learning in my area, which makes libraries very important. Having a location nearby where someone is able to check out books freely that they might not have been able to have access to is very important....
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...Feature Deming’s 14 Principles Background Recent changes in regulatory requirements for clinical trials pose considerable challenges for the clinical research community. The clinical research Quality Assurance (QA) profession as a whole has not historically utilised quality management tools, and QA professionals may have little to no formal training in continuous improvement methods, to be aware of their value in assessing and improving the impact and value of the QA department to any organisation. This article will present Deming’s 14 Principles for Management, paraphrasing them to demonstrate how easily they can apply to the clinical trial project management, Contract Research Organisation (CRO) and clinical department management. Deming’s 14 Principles Dr. William Edwards Deming is known as the father of the Japanese post-war industrial revival and was regarded by many as the leading quality guru in the United States. Deming created 14 Principles for Management that summarised his business philosophy. The principles became a basis for transformation of industry. The 14 principles apply anywhere, from small organisations to large ones, to the service industry as well as to manufacturing. They apply to any division within a company. 2. Adopt the New Philosophy Management should actually adopt the ‘quality philosophy’, rather than merely expect the workforce to do so. When the new clinical trial project is thoroughly planned and the quality matters are carefully embedded...
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...employees (“Our Company,” 2011). Parexel has made its’ niche by assisting clients in clinical research trials. Parexel does not work in one area, but all major therapeutic areas “including: Cardiology, Oncology, Infectious Diseases, Neurology, Allergy/Immunology, Endocrinology/Metabolism, Gastroenterology, Obstetrics, Gynecology, Orthopedics, Pediatrics, Psychiatry and Transplantation” (“Clinical research experience and expertise”, 2011). Clearly, Parexel has put themselves in the position to not be limited by simply one area of proficiency. While they are proficient in many different types of clinical trials, they have definitely found a niche in which they can excel. Parexel does, however, have a list of studies and programs to help assist both Parexel and the companies which they contract with to achieve their goals. These programs/studies include safety/pharmacovigilence, health economics, and epidemiology, among others (“Clinical research experience and expertise”, 2011). Further, under their “industries” page, Parexel claims to offer a “broad range of services – from strategy to commercialization” (“Industries”, 2011). So besides offering clinical trial services, Parexel assists other companies with their development and direction of new products. In Parexel’s 2010 Annual Report, of the three major services the company provides, 77% of income came from clinical research services, 12% from perceptive informatics, and 11% from consulting and medical communication services...
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...Compare, Contrast and Discuss Mechanistic vs. Organic Structures Vance Conyers Organizational Theory 360A 28 September 2012 Organization structure is “The formal system of task and authority relationships that control how people coordinate their actions and use resources to achieve goals”. (Jones 8) The structure that an organization forms can determine its ultimate success of failure. It sets the foundation for how the organization will function, make decisions, and respond to change. The two types of structures an organization can use are mechanic and organic. Mechanistic and organic structures both have advantages and disadvantages, and neither one is a perfect solution. Depending on the product, tasks to create the product, and people to create the product, make the decision very challenging. In most cases, elements of both types are implemented to ensure a successful business. The executive management is responsible for formulating the right mix in order to achieve success. They use organizational design to process information to select the best options. Every aspect of this decision will play out from how much power middle managers have, to the scope of responsibility direct supervisors encompass. The type of organization directly affects the culture and moral of employees. Implementation of the wrong type or mix of structure can cause mismanagement of resources (both human and physical), a toxic culture, and ultimately a failed institution. The mechanistic structure...
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...for our lives. Face it, it would be a world of demise and destruction. Though daunting to imagine, it serves as somber reminder how valuable nonprofit organizations are to society. Nonprofit organizations exist to cater to the various needs of society, and to accomplish their charitable mission. The service and product offered are not for achieving profits, but to benefit society in a noticeable manner. However, in order for nonprofit organizations to maintain efficiency and meet their goals; it is essential for them to operate to their full capacity by implementing good financial management systems and procedures. Financial management plays a significant role in the overall management of a nonprofit organization. Implementing appropriate financial management systems and practices contribute to a successful business and provides...
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...An organization I would fund today would be a nonprofit organization that helps animals. If I had all the money in the world, I would give money to every nonprofit animal organization. I am a huge animal lover and I would do anything to try to save animals and find them new homes. I do not understand how anyone could hurt an animal. They are just innocent, lovable, furry friends and people who abuse them break my heart. Also, bringing awareness to people to get their animals fixed helps with homeless animals. It can cost some money to get your pet fixed, but it costs even more money if that animal has babies of its own. Most of the time those animals end up homeless, which can then lead to more baby animals being born and the cycle just continues....
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...Organizational Management in a Contract Research Organization Susan Green Management 330: Management for Organizations Instructor Jeffry Otterstetter July 2, 2012 Organizational Management in a Contract Research Organization For the past seven years I have been employed by an organization that is recognized, globally, as a leader within the industry. We are a contract research organization – a company hired by various biotech and pharmaceutical companies to maximize returns on their Research and Development (R&D) investments through the management of clinical trials. In order to maintain the status of a global leader in our industry we must deliver consistent quality and execution, exceptional customer-aligned service and constant innovation – none of which can be successfully delivered without exceptional organizational management. There are multiple facets of our organization that must come together to ultimately deliver to the expectations of our clients, and effective management through planning/organizing, staffing, leading, and control are key to our continued success. In this paper I will discuss these concepts and, specifically, how they are implemented within our company. The planning and organizing functions within an organization serve, perhaps, the most important purpose – determining the goals of the company and how to achieve them. An organizational plan is ever evolving as a result of the assessment of internal strengths and weakness...
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...Administrations of justice organizations are the correctional facilities in the criminal justice today that oversee the enforcement of laws. Justice organizations include courts and correctional facilities in the criminal justice system. Administration of justice organizations are intended to promote justice for all citizens by punishing the guilty in society and giving them a chance to rehabilitate in the correctional facilities. They also seek to protect the innocent and accomplish court orders such as imposing fines (Abel & Sementelli, 2007, p. 56). The administration of justice organizations is mainly three major components and they include police and law enforcement, courts and the court system and correctional facilities and rehabilitation...
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...Shawn J. Burtner SW-SO-214 September 25, 2012 Chapter 4 Pg. 165-175 Social Dimension Socialization It is almost impossible to count how many times we hear a child scream or cry when left with a care giver, at school, or even when a stranger looks at them in the supermarket. And although we notice these things, we don't usually connect them with being unnatural or unnecessary. But in fact, we should. There is hardly a need to experience such things, and that goes for the child as well as the parent. It is a given that a child will cry, it is also given that the child will be reluctant to leave the parent. However, this anxiety can be eased by applying a principle that is very simple. Socialization, it's a concept that many people aren't consciously aware of, yet it is experienced every day in many different aspects of life. Ones manners, people skills, and the like are all a result of one’s socialization. Even pets are now socialized in order to better prepare them to interact with other animals when walking in the city or the park. So why then is socialization such a strange and foreign concept to parents? To put it simply, children should being socialization at a young age to prepare them to interact with other children and adults as they grow. Socialization alone can move a child from having a dramatic experience when being left with a care giver to a more pleasant one. Not only does the child benefit from this, but the parents do as well. Often parents feel that...
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...Impact of Office Automation on the Organization: Some Implications for Research and Practice M a r g r e t h e H. O l s o n a n d H e n r y C. L u c a s Jr. New York University Computer technology has recently been applied to the automation of office tasks and procedures. Much of the technology is aimed not at improving the efficiency of current office procedures, but at altering the nature of office work altogether. The development of automated office systems raises a number of issues for the organization. How will this technology be received by organization members? How will it affect the definition of traditional office work? What will be its impact on individuals, work groups, and the structure of the organization? This paper presents a descriptive model and propositions concerning the potential impacts of office automation on the organization and it stresses the need, when implementing automated office systems, to take a broad perspective of their potential positive and negative effects on the organization. The need for further research examining the potential effects of office automation is emphasized. CR Categories and Subject Descriptors: J. 1 [Administrative Data Processing]--business; K.4.3 [Computers and Society]: Organizational Impacts General Terms: Experimentation, Management, Theory, Human Factors Additional Key Words and Phrases: office automation, automated office systems, impact on organizations, electronic mail Authors' Present...
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