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Journal articles on the topic 'Pharmaceutical Contract Sales Organizations'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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1

Volgina, Natalia A. "Pharmaceutical value chain: opportunities for outsourcing." RUDN Journal of Economics 29, no. 1 (2021): 150–63. http://dx.doi.org/10.22363/2313-2329-2021-29-1-150-163.

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Industry value chains take important place in the architecture of the global economy. In recent years, cross-border pharmaceutical value chains have been actively developing, the formation of which took place both through offshoring and outsourcing processes under the control of Big Pharma companies, which keep leading positions in the pharmaceutical markets. The study evaluates the possibilities of outsourcing, as well as identifies its features at various stages of the pharmaceutical chain. The multistage pharmaceutical chain, as well as its high degree of its modularity, have created favour

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2

Larkin, Joseph M. "Optimizing Resource Allocations With A Strategic Focus: An Accounting Perspective." Journal of Business Case Studies (JBCS) 5, no. 5 (2011): 55. http://dx.doi.org/10.19030/jbcs.v5i5.4721.

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This case focuses upon the pharmaceutical industry and key financial and strategic management decisions. An international pharmaceutical firm plans to launch a new product. The organization must decide whether or not to increase their internal sales force or hire a Contract Sales Organization for the product launch. Students will have to analyze the quantitative cost information as well as consider qualitative considerations.

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Armando, Pedro D., Sonia A. Uema, and Elena M. Vega. "Integration of Community pharmacy and pharmacists in primary health care policies in Argentina." Pharmacy Practice 18, no. 4 (2020): 2173. http://dx.doi.org/10.18549/pharmpract.2020.4.2173.

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Argentina is a federal republic with approximately 44 million people, divided into 23 provinces and an autonomous city, Buenos Aires. The health system is segmented into public, social security and private subsystems. The social security and private sectors cover more than 60% of the population. Total health expenditure in 2017 was 9.4% of gross domestic product. Primary health care (PHC) was considered as the principal strategy for universal coverage policy for health system reform in Latin America at the end of 20th century. The most remarkable characteristics of the Argentinian health syste

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Dotter, Thomas A., and Vess L. Johnson. "Interactive visual aid adoption within pharmaceutical sales organizations." Computers in Human Behavior Reports 2 (August 2020): 100017. http://dx.doi.org/10.1016/j.chbr.2020.100017.

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5

Wardell, William. "The Changing Environment Within Contract Research Organizations." Clinical Research and Regulatory Affairs 14, no. 3-4 (1997): 265–74. http://dx.doi.org/10.3109/10601339709080084.

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6

Wilson, Ellis, James McDonough, William Allbee, and Jann Nielsen. "Project Management as a Discipline within Pharmaceutical Contract Research Organizations." Drug Information Journal 37, no. 2 (2003): 207–13. http://dx.doi.org/10.1177/009286150303700209.

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7

Luh, Yir-Hueih. "Inclusiveness of Contract Farming along the Modern Food Supply Chain: Empirical Evidence from Taiwan." Agriculture 10, no. 5 (2020): 187. http://dx.doi.org/10.3390/agriculture10050187.

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One of the debates in the literature of contract farming concerns contracting firms’ preferences over large growers and if contract farming is inclusive of smallholders. The empirical evidence was mixed, which may be due to ignoring the stylized fact that modern food supply chain is characterized by large organized retailers who often contract with farmers. The present study aims at addressing this issue by incorporating sales to supermarket and hypermarket chains as one of the determinants of contract farming participation. Based on a nationally-representative farm household data set in Taiwa

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Steadman, Victoria A. "Drug Discovery: Collaborations between Contract Research Organizations and the Pharmaceutical Industry." ACS Medicinal Chemistry Letters 9, no. 7 (2018): 581–83. http://dx.doi.org/10.1021/acsmedchemlett.8b00236.

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9

Huang, Jianan. "Contract Research Organizations Are Seeking Transformation in the Pharmaceutical Value Chain." ACS Medicinal Chemistry Letters 10, no. 5 (2019): 684–86. http://dx.doi.org/10.1021/acsmedchemlett.9b00046.

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10

Rosenzweig, Pierre. "Selection Criteria for Phase I Contract Research Organizations by Pharmaceutical Companies." Drug Information Journal 32, no. 3 (1998): 825–30. http://dx.doi.org/10.1177/009286159803200322.

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11

Ball, Christopher. "The role of contract research organizations in the new pharmaceutical industry." Pharmacological Research 31 (January 1995): 22. http://dx.doi.org/10.1016/1043-6618(95)86346-x.

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12

Jridi, Kaouther, Amel Chaabouni, and Abdelfattah Triki. "Reconciliation of deterministic and knowledge management approaches for a better understanding of SFA’s impact on salespersons’ performance." VINE Journal of Information and Knowledge Management Systems 49, no. 3 (2019): 353–71. http://dx.doi.org/10.1108/vjikms-11-2018-0103.

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Purpose The purpose of this study is to reconcile the deterministic and the knowledge management approaches to investigate a framework that provides an explanation of the sales force automation (SFA) practices’ impact on salespersons’ performance through the organizational absorptive capacity in the African pharmaceutical industry. Design/methodology/approach An exploratory study was conducted to understand SFA uses in the pharmaceutical industry; then a total of 186 medical representatives were sampled and partial least squares analysis was performed. Findings The results identified the posit

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13

Krichbaum, Daniel, and Alan Rosenthal. "Contract Clinical Research: A Rapidly Changing Marketplace." Journal of Pharmacy Practice 9, no. 6 (1996): 406–15. http://dx.doi.org/10.1177/089719009600900604.

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Drug development in the United States has undergone considerable change over the past decade. The outsourcing of clinical research activities to Contract Research Organizations (CROs) continues to escalate in an attempt to speed drugs to market faster. The increasing use of business strategies at the investigational site level has fostered the emergence of specialty networks and Site Management Organizations (SMOs). SMOs offer pharmaceutical and biotechnology sponsors the ability to work with a tightly managed network of experienced professional multispecialty research centers that can enroll

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14

Purohit, Basant. "Salesperson performance: role of perceived overqualification and organization type." Marketing Intelligence & Planning 36, no. 1 (2018): 79–92. http://dx.doi.org/10.1108/mip-06-2017-0108.

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Purpose The purpose of this paper is to examine the impact of perceived overqualification (POQ) on salesperson performance. Design/methodology/approach In total, 120 usable samples were collected from surveying sales representatives and their sales supervisors from 48 different Indian pharmaceutical firms. Findings The results indicated that sales personnel with POQ perform well: in prospector and analyzer type organizations as compared to in defender and reactor type organizations, and when controlled by the outcome-based control system than when controlled by the behavior-based control syste

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15

Shahbaz, Muhammad, Changyuan Gao, Lili Zhai, Fakhar Shahzad, Adeel Luqman, and Rimsha Zahid. "Impact of big data analytics on sales performance in pharmaceutical organizations: The role of customer relationship management capabilities." PLOS ONE 16, no. 4 (2021): e0250229. http://dx.doi.org/10.1371/journal.pone.0250229.

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In this era of technology development, every business wants to equip its salesforce with a sustainable salesforce automation system to improve sales performance and customer relationship management (CRM) capabilities. This study investigates the impact of big data analytics (BDA) on CRM capabilities and the sales performance of pharmaceutical organizations. A research model was tested based on 416 valid responses collected from pharmaceutical companies through a structured questionnaire. Structural equation modeling (SEM) was employed using Smart-PLS3 to confirm the contribution of BDA to impr

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16

Toda, Kenji. "Opportunities for Contract Research Organizations to Work with the Global Japanese Pharmaceutical Industry." Drug Information Journal 27, no. 4 (1993): 1137–39. http://dx.doi.org/10.1177/009286159302700430.

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17

Hassanzadeh, Farhad, Mohammad Modarres, Hamid R. Nemati, and Kwasi Amoako-Gyampah. "A robust R&D project portfolio optimization model for pharmaceutical contract research organizations." International Journal of Production Economics 158 (December 2014): 18–27. http://dx.doi.org/10.1016/j.ijpe.2014.07.001.

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18

Marinkovic, Valentina, Ina Heine, Andrijana Milosevic Georgiev, and Robert H. Schmitt. "Critical incidents of outsourcing processes in pharmaceutical supply chain: A mixed-methods approach." Journal of Industrial Engineering and Management 13, no. 3 (2020): 495. http://dx.doi.org/10.3926/jiem.3085.

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Purpose: In this paper, a practical framework is presented for the successful integration of buyers and contract organizations based on the Critical Incident Technique (CIT).Methodology: The initial pool of situations was developed inductively according to qualitative data provided by ten experts in the field of outsourcing in pharmaceutical supply chain. Another group of experts evaluated these situations with regard to their degree of realism as well as relevance and allocated them to the five constructs (1) employee competence, (2) management commitment, (3) communication between organizati

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Ganguly, Anirban, Chitresh Kumar, and Debdeep Chatterjee. "A Decision-making Model for Supplier Selection in Indian Pharmaceutical Organizations." Journal of Health Management 21, no. 3 (2019): 351–71. http://dx.doi.org/10.1177/0972063419868552.

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Supplier selection is the process by which firms identify, evaluate and contract with suppliers. The supplier selection process deploys a tremendous amount of a firm’s operational and financial resources and is considered as an important determinant of the success of its supply chain. In spite of being strategically important to organizations, the decision for supplier selection is often complex and unstructured. Furthermore, it is inherently a multi-criterion decision-making (MCDM) problem, which pertains to structuring and solving decision problems involving multiple criteria. The paper prov

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20

McWilliams, J. Christopher, Ayman D. Allian, Suzanne M. Opalka, Scott A. May, Michel Journet, and Timothy M. Braden. "The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations." Organic Process Research & Development 22, no. 9 (2018): 1143–66. http://dx.doi.org/10.1021/acs.oprd.8b00160.

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21

Sun, Lanying, and Xiaoyan Li. "Comparison analysis on the bilateral efforts of farmers and the third-party organization under multiple contract modes." Kybernetes 48, no. 5 (2019): 818–34. http://dx.doi.org/10.1108/k-03-2018-0102.

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Purpose The purpose of this paper is under the analysis framework of the system theory, analyzing the optimal contract mode of agricultural supply chain to guarantee the stability of agricultural supply chain and the equilibrium of agricultural product market, to analyze the effect of farmers’ risk attitude on the selection of contract modes and to find the way to encourage farmers’ productive effort and to avoid farmers’ hitchhiking behavior, to guarantee the stability of agricultural supply chain. Design/methodology/approach Under the guidance of the system theory, using the Stackelberg mode

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22

Santosh Kumar, Rada, and Sangbit Paul. "Contract Research Organization (CRO): An Important Partner to Biotechnological and Pharmaceutical Companies." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 759–61. http://dx.doi.org/10.22270/jddt.v9i4-a.3481.

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With the ever increasing Research and Development cost for the pharmaceutical industries, the cost of bringing a drug to market was increasing drastically. The funds for drug development was drying up and thus to maintain a healthy profit margin , the pharmaceutical companies have adopted to frame out research and development (R&D) to Contract Research Organizations (CRO’s). The CRO’s have become an important partner to biotechnological and pharmaceutical companies, in the development of new compounds and at the same time in drug registration also it has extended its hands. Out of 20, 19 p

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23

Susharina, I. V., A. S. Nemchenko, and V. M. Homenko. "Assessing the effectiveness of pharmaceutical public organizations using of questionnaires specialists." Farmatsevtychnyi zhurnal, no. 1 (August 14, 2018): 11–19. http://dx.doi.org/10.32352/0367-3057.1.17.02.

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Today in Ukraine insufficient amount of scientific publications in which explores issues of interaction of authorities with civil society organizations. Given the large number of associations in the domestic pharmaceutical, research on the effectiveness of their work yavlyayutsya relevant. The aim of this work was the evaluation of pharmaceutical activities of public organizations and determine ways to improve their effectiveness. Materials research is the result of a questionnaire survey of managers and specialists, conducted over the past ten years on the evaluation of the effectiveness of t

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24

Shahbaz, Muhammad, Changyuan Gao, Lili Zhai, Fakhar Shahzad, Adnan Abbas, and Rimsha Zahid. "Investigating the Impact of Big Data Analytics on Perceived Sales Performance: The Mediating Role of Customer Relationship Management Capabilities." Complexity 2020 (June 22, 2020): 1–17. http://dx.doi.org/10.1155/2020/5186870.

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A persistent question for information technology researchers and practitioners is how big data analytics (BDA) can improve sales performance. Therefore, this study proposed a research model to investigate the impact of BDA on perceived sales performance in accordance with the resource-based view (RBV) and dynamic capability theory. The 416 valid responses collected from the employees of pharmaceutical organizations were analyzed using structural equation modelling to test the proposed research model. Results indicated that the BDA and customer relationship management (CRM) capabilities shared

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25

Bassion, Susan. "Standardizing Laboratory Data Interchange in Clinical Trials." JALA: Journal of the Association for Laboratory Automation 7, no. 5 (2002): 62–64. http://dx.doi.org/10.1016/s1535-5535-04-00219-9.

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The Clinical Data Interchange Standards Consortium has developed a Laboratory Model for laboratory data that is generated during the conduct of clinical trials. The Laboratory Model is the first step in proposing standards for the interchange of clinical trial laboratory data. Standards will decrease the time and resources required by stakeholders in the pharmaceutical development process (pharmaceutical companies, biotechnology companies, contract research organizations and laboratories). Standardization will therefore contain costs as well as improve data quality.

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26

Macchetto, Claudio. "Intellectual Property Negotiations: A Managerial Perspective of Basic Intellectual Property Issues for Small Pharmaceutical Companies in Research Contract Negotiations with Contract Research Organizations." Drug Information Journal 29, no. 1 (1995): 131–37. http://dx.doi.org/10.1177/009286159502900118.

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27

Henderson, Neil, and Amanda Wilson. "Measurement of mRNA therapeutics: method development and validation challenges." Bioanalysis 11, no. 21 (2019): 2003–10. http://dx.doi.org/10.4155/bio-2019-0120.

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The progression of chemically modified mRNA therapeutics through development pipelines is accelerating for many disease indications and the need to assess these analytes is becoming more routine for the pharmaceutical industry and contract research organizations. This article describes some of the challenges and strategies for performing regulated bioanalysis of modified mRNA therapeutics by comparing the two main analytical approaches – quantitative reverse transcription PCR and branched DNA.

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Кайтбек, А. К., and Г. А. Дюсембинова. "INFLUENCE OF SALES PROMOTION METHODS ON CONSUMER PURCHASING DECISIONS IN PHARMACY ORGANIZATIONS." Farmaciâ Kazahstana, no. 3 (July 16, 2021): 66–70. http://dx.doi.org/10.53511/pharmkaz.2021.86.41.017.

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Данное исследование направлено на выявление наиболее распространенных и эффективных инструментов стимулирования продаж, которые используются аптеками и фармацевтическими компаниями для того чтобы потребитель принял решение о покупке продукции. Результаты исследования показали, что, по мнению всех респондентов, техника стимулирования торговли оказывала самое сильное влияние на решения потребителей о покупке, в то время как мерчандайзинг был наиболее распространенным методом стимулирования продаж в местных аптеках. Респонденты определили стимулирование торговли как наиболее эффективный и распрос

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Adler, Rick, Elizabeth Clark, Mark Cline, et al. "Mission Accomplished: The ACVP/STP Coalition for Veterinary Pathology Fellows Completes Its Objectives, but Its Legacy and Spirit Live On." Toxicologic Pathology 48, no. 4 (2020): 603–6. http://dx.doi.org/10.1177/0192623320917970.

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After 15 years of existence, the ACVP/STP Coalition for Veterinary Pathology Fellows will dissolve, primarily due to lack of renewed financial sponsorship. While in operation, the Coalition organized 32 new training position for veterinary pathologists, supported by $7.4 M from sponsors, including pharmaceutical and biotechnology companies, contract research organizations, private individuals and allied veterinary pathology support groups. All residual funds will be donated to ACVP and STP with the understanding that the two organizations will use these funds to enhance training by collaborati

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Adler, Rick, Elizabeth Clark, Mark Cline, et al. "Mission Accomplished: The ACVP/STP Coalition for Veterinary Pathology Fellows Completes Its Objectives, but Its Legacy and Spirit Live On." Veterinary Pathology 57, no. 4 (2020): 472–75. http://dx.doi.org/10.1177/0300985820918314.

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After 15 years of existence, the ACVP/STP Coalition for Veterinary Pathology Fellows will dissolve, primarily due to lack of renewed financial sponsorship. While in operation, the Coalition organized 32 new training position for veterinary pathologists, supported by $7.4 M from sponsors, including pharmaceutical and biotechnology companies, contract research organizations, private individuals and allied veterinary pathology support groups. All residual funds will be donated to ACVP and STP with the understanding that the two organizations will use these funds to enhance training by collaborati

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Sattar, Muhammad Muzamil, Asad Ali Qazi, Farhan Shahzad, and Abdul Rehman Shaikh. "Flori Pharma: maintaining ethics in an unethical sales environment." Emerald Emerging Markets Case Studies 10, no. 1 (2020): 1–21. http://dx.doi.org/10.1108/eemcs-07-2019-0187.

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Learning outcomes The learning outcomes are as follows: what tasks are to be done by medical representatives in pharmaceutical industry? This study also highlights various competencies required to do effective selling in this industry; analyzes and discusses different unethical practices going on in the market; explains why ethical norms are necessary in sales context when sales targets are already achievable with unethical means; and develops and comments on strategies Flori Pharmaceutical can make to overcome on these unethical issues. What should be the response of Dahar to the email of Nav

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Ali, Bakhtiyar, Muhammad Abu Bakr Ali, and Shameel Ahmed Zubairi. "The Impact of Salesforce Motivation on Organizational Performance in Pharmaceutical Industry of Karachi, Pakistan, 2019." International Journal of Industrial Marketing 5, no. 1 (2020): 34. http://dx.doi.org/10.5296/ijim.v5i1.17196.

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The pharmaceutical industry in Pakistan is a very demanding market that is always subject to competitive pressures. This research objects to define the interaction (Intrinsic, Extrinsic) of motivational factors for the salesforce teams in pharmaceuticals with respect to company performance. It will test the relevance of modern motivation theories in their attempt to explain the importance of the determinants of motivation in the context of performance by the sales force in Karachi, Pakistan For the execution of the current research and catering to the research questions in an effective manner,

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Wilson, Bradley. "Delivering the Goods: Fair Trade, Solidarity, and the Moral Economy of the Coffee Contract in Nicaragua." Human Organization 72, no. 3 (2013): 177–87. http://dx.doi.org/10.17730/humo.72.3.f678404745007011.

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This paper explores a deceptively simple question: why do peasant farmers participate in Fair Trade coffee networks? Campaigns touting Fair Trade often suggest that farmers are incentivized to participate due to price premiums and social development benefits. However, a growing literature documenting development outcomes in coffee farming communities suggests that farmers do not reap the benefits of Fair Trade in the way they are presented in the global North. I draw upon ethnographic research in a community that is one the earliest suppliers of Fair Trade in Nicaragua. Combining participant o

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Umarov, Sergey Z. "Processing and evaluation of qualitative data of the pharmaceutical market using economic and statistical methods." Pharmacy Formulas 2, no. 1 (2020): 44–52. http://dx.doi.org/10.17816/phf25738.

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In competitive conditions of the pharmaceutical market, a significant factor is the problem of identifying market trends; the need to identify competitors and threats, resources assessment. For this purpose, it is necessary to constantly collect and generate data on the basis of which an informed decision is developed by the heads of pharmacy organizations. However, a certain category of pharmaceutical management believes that business decision-making should be based solely on intuition and practical experience, which excludes the use of any quantitative information. In the course of the

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Waheed, Abdul, Jianhua Yang, and Jon K. Webber. "The Effect of Personality Traits on Sales Performance: An Empirical Investigation to Test the Five-Factor Model (FFM) in Pakistan." Interdisciplinary Journal of Information, Knowledge, and Management 12 (2017): 139–57. http://dx.doi.org/10.28945/3710.

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Aim/Purpose: The present study investigates the relationship between the five-factor model (FFM) of personality traits and sales performance in Pakistan. Background: Personality is a well-researched area in which numerous studies have examined the correlation between personality traits and job performance. In this study, a positive effect between the various dimensions of the five-factor model (extraversion, agreeableness, conscientiousness, emotional stability, and open to experience) and sales performance in Pakistan is investigated. Methodology: Pearson’s correlation values as well as analy

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Domagalska-Grędys, Marta. "FACTORS OF IMPLEMENTATION AND IMPORTANCE IN THE PROCESS OF KNOWLEDGE EXCHANGE IN THE CONSERVATIVE ANIMALS NETWORK OF BREEDERS AND INDUSTRY ORGANISATIONS. THE POLISH CASE." Annals of the Polish Association of Agricultural and Agribusiness Economists XXI, no. 2 (2019): 38–48. http://dx.doi.org/10.5604/01.3001.0013.2082.

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Knowledge is a key resource to support European agriculture in meeting today’s challenges such as global competition, food safety, human, animal and plant health as well as environmental protection requirements. The question arises as to which organisations in the current institutional system of agriculture provide knowledge to farmers who keep livestock of conservative breeds at the expected level of quality and exchange (frequency)? The aim of the research was to identify a new role of industry organisations in the transfer of knowledge and indicate variables determining the importance and e

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Moon, Sangkil, Wagner A. Kamakura, and Johannes Ledolter. "Estimating Promotion Response When Competitive Promotions Are Unobservable." Journal of Marketing Research 44, no. 3 (2007): 503–15. http://dx.doi.org/10.1509/jmkr.44.3.503.

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This study addresses a problem commonly encountered by marketers who attempt to assess the impact of their sales promotions—namely, the lack of data on competitive marketing activity. In most industries, competing firms may have competitive sales data from syndicated services or trade organizations, but they seldom have access to data on competitive promotions at the customer level. Promotion response models in the literature either have ignored competitive promotions, focusing instead on the focal firm's promotions and sales response, or have considered the ideal situation in which the analys

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Nair, Unnikrishnan K., and Keyoor Purani. "KHL: Consulting for Managing Sales Force Attrition (A)." Asian Journal of Management Cases 15, no. 2_suppl (2018): S25—S43. http://dx.doi.org/10.1177/0972820118806399.

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Kalpak Healthcare Limited (KHL), a large pharmaceutical company in the southern part of India, once faced severe sales force turnover in its Life Branded Medications SBU, popularly called the Branded SBU (B-SBU). It became an issue of highest concern to the top management of KHL; so they appointed a team of consultants from a premier management school in the region to study the issue and recommend possible solutions and strategies. Over a period of 6 months, the consultants conducted extensive research—studying internal company records, analysing the industry and external environment, gatherin

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Nair, Unnikrishnan K., and Keyoor Purani. "KHL: Consulting for Managing Sales Force Attrition (B)." Asian Journal of Management Cases 15, no. 2_suppl (2018): S44—S54. http://dx.doi.org/10.1177/0972820118806434.

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Kalpak Healthcare Limited (KHL), a large pharmaceutical company in the southern part of India, was facing severe sales force turnover in its Life Branded Medications SBU, popularly called the Branded SBU (B-SBU). It became an issue of highest concern to the top management of KHL; so they appointed a team of consultants from a premier management school in the region to study the issue and to recommend possible solutions and strategies. Over a period of six months, the consultants conducted extensive research—studying internal company records, analysing the industry and external environment, gat

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40

Bhandari, Arabinda. "How Strategic Retail Loyalty can Help Indian Pharmaceutical Organization in Competitive Advantage- A Prospective Study." Nile Journal of Business and Economics 3, no. 7 (2017): 65. http://dx.doi.org/10.20321/nilejbe.v3i7.121.

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<p>Today’s complexity of modern business is helping managers to innovate new strategy to retain the customer in competitive environment. To maintain a long lasting relationship, organizations are offering certain sales promotional activities to attract the customer. As the pharmaceutical industry has highly knowledge based product, high Intensity of product information, employee are younger in age and organization has geographically-distributed business, so SMAC track melting point may well be near.</p><p>Technology is reshaping the retail landscape of Indian pharmaceutical b

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Vose, Julie M., Meredith K. Chuk, and Francis Giles. "Challenges in Opening and Enrolling Patients in Clinical Trials." American Society of Clinical Oncology Educational Book, no. 37 (May 2017): 139–43. http://dx.doi.org/10.1200/edbk_179807.

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Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and

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Prajapati, Jignesh, and Darshit Patel. "Generic Drug User Fee Act II: The positive features for generic drug industry." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 13, no. 4 (2017): 206–13. http://dx.doi.org/10.1177/1741134317713800.

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The US Food and Drug Administration (FDA) and the Generic Drug Industry have completed negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA II). The agreement is now with Congress, which must write it into legislation in order for it to become effective. GDUFA II addresses questions that arose with the implementation of GDUFA I. One of the primary concerns with GDUFA I was that it did not provide any relief for small business whereas GDUFA II addresses relief for small business. GDUFA II has carved out a subcategory for Contract Manufacturing Organizations (CMOs), which

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Zachary, Rebecca. "Formulary Management from a Health Maintenance Organization (HMO) Perspective." Journal of Pharmacy Practice 7, no. 2 (1994): 68–73. http://dx.doi.org/10.1177/089719009400700204.

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With the rise of managed care, formularies are being increasingly employed in the outpatient setting to manage use and control costs of prescription drugs. The formulary management policies of various managed care organizations are widely diverse and are largely dependent on the organizational structure of the managed care program. Although reasons for choosing certain types of formulary systems will be briefly explored, this article primarily focuses on formulary management tools used in the group model HMO setting. Various aspects of the formulary process that require ongoing management are

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Grentikova, I. G., and A. A. Oblasov. "FORMATION OF AN INTEGRATED MARKETING SYSTEM FOR A PHARMACY ORGANIZATION." Economics Profession Business, no. 3 (September 14, 2020): 35–39. http://dx.doi.org/10.14258/epb201984.

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The article substantiates the need for the formation of an integrated marketing system by Russian pharmaceutical organizations, which allows them to sell pharmaceutical products based on the foresight of future needs and consumer preferences. The rapid transformation of retail trade after the removal of restrictive measures taken in connection with the coronavirus pandemic will affect the pharmacy business; there is a need to develop and use all tools to improve the quality of business management, which will directly affect sales. The authors justify the use of an organizational scheme consist

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Balkissoon, Jai, Binh Nguyen, Austin J. Combest, et al. "Managing combination immunotherapy trials from a contract research organization's (CRO's) perspective." Journal of Clinical Oncology 37, no. 8_suppl (2019): 19. http://dx.doi.org/10.1200/jco.2019.37.8_suppl.19.

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19 Background: With the increased clinical activity that we are seeing with combination IO therapies, more sponsors are searching for contract research organizations (CROs) that have experience managing combination IO clinical trials which are often large, complex, multi-national, resource-intensive, competitive and highly specialized. Pharmaceutical Product Development (PPD), a contract research organization (CRO) has worked with sponsors in managing combination IO clinical trials. This includes early and late phase trials with many different classes of agents in multiple tumor types. We soug

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Haidar, Sam H., Diaa Shakleya, Jiang Wang, Xiaohan Cai, and Patrick Faustino. "Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis." Bioanalysis 11, no. 20 (2019): 1823–34. http://dx.doi.org/10.4155/bio-2019-0215.

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Aim: Contract research organizations and pharmaceutical firms have performed stability testing using one of two methods: storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and analysis; and storing three tubes for each quality control concentration, followed by analysis (Method 2). This research project was conducted to determine if there were detectable differences between Method 1 and Method 2. Methodology: Five model drugs were selected: teriflunomide (stable compound) and acetyl salicylic acid, simvastatin, tenofovir ala

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Choudhary, Shambhunath, Tanasa Osborne, Rick R. Adler, Kevin S. McDorman, John E. Dillberger, and Ricardo Ochoa. "Career Transition Points in Toxicologic Pathology: Management and Consulting." Toxicologic Pathology 45, no. 7 (2017): 1012–21. http://dx.doi.org/10.1177/0192623317736299.

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In the constantly evolving field of toxicologic pathology, a pathologist’s career is often characterized by multiple career transitions. However, these transitions can be challenging and/or overwhelming and may require a shift in focus, strategic approach, and acquisition of new skills and expertise. In order to provide a forum to discuss challenges associated with career transitions and skill set/competencies required to navigate career changes effectively and successfully, the Career Development and Outreach Committee of the Society of Toxicologic Pathology (STP) sponsored a career developme

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Davis, Arlene M., Sara Chandros Hull, Christine Grady, Benjamin S. Wilfond, and Gail E. Henderson. "The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection." Journal of Law, Medicine & Ethics 30, no. 3 (2002): 411–19. http://dx.doi.org/10.1111/j.1748-720x.2002.tb00410.x.

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Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the p

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Lhotska, Lida, Judith Richter, and Maryse Arendt. "Protecting Breastfeeding From Conflicts of Interest." Journal of Human Lactation 36, no. 1 (2019): 22–28. http://dx.doi.org/10.1177/0890334419885859.

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In order to maximize profits from sales of breastmilk substitutes, manufacturers use a whole gamut of strategies to interfere with the effective implementation of policies that protect, promote, and support breastfeeding (e.g., the International Code of Marketing of Breastmilk Substitutes with its subsequent World Health Assembly resolutions and the Global Strategy on Infant and Young Child Feeding). Their strategies create, among other problems, personal and institutional conflicts of interest. Effective Conflict of Interest policies are therefore needed for ensuring that governments, interna

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Kudrin, Alex. "Overview of the biosimilars: Strategic considerations of various issues." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 9, no. 4 (2012): 187–206. http://dx.doi.org/10.1177/1741134312470444.

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Compared to well-established generic medicines that are routinely developed using the bioequivalence approach and identical drug substances, biosimilars are developed using a step-wise comparability exercise aimed at demonstrating similar but not identical quality, non-clinical and clinical attributes. Biosimilar development is not intended to demonstrate the clinical benefits of the product as millions years of exposure data are currently available for the many originator monoclonal antibodies but rather to demonstrate a high degree of similarity against the reference using analytical and non

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