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Journal articles on the topic 'CRO (Contract Research Organization)'

Author: Grafiati
Published: 4 June 2021
Last updated: 2 February 2022

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1

Nagata, Ryoichi. "Translational research business by Contract Research Organization." Folia Pharmacologica Japonica 136, no. 1 (2010): 42–45. http://dx.doi.org/10.1254/fpj.136.42.

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2

Chernykh, S. I. "Competition among the Contract Research Organizations." Russian competition law and economy, no. 2 (June 30, 2019): 30–35. http://dx.doi.org/10.32686/2542-0259-2019-2-30-35.

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The article deals with the current theoretical and practical issues relating to the development of competition among contract research organizations (CRO), and the role of the State in the development of institutions and mechanisms that ensure the development science on a competitive basis. Concludes that the need for further improving the legal and institutional framework to successfully meet the challenges of scientific and technological development through the contract paradigm.
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3

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 (August 30, 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 pharmaceutical companies have invested in emerging markets like China, India, Russia and Latin America since clinical research is accessible to these markets due to adoption of ICH and GCPs guidelines. The traditional nature of CRO’s have changed and they will develop into a formidable industry in near future.
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Handayani, Erna, Heru Kurnianto Tjahjono, and Akhmad Darmawan. "Uniqueness of psychological contract in a faith-based organization (FBO)." International Journal of Research in Business and Social Science (2147- 4478) 9, no. 6 (October 26, 2020): 58–64. http://dx.doi.org/10.20525/ijrbs.v9i6.912.

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This study aims to explore the uniqueness of the psychological contract in the Faith-Based Organization (FBO). Psychological contracts, as part of the bond between individuals and organizations, are constantly evolving research. In line with the Conservation of Organizational Resources (COR) theory, organizations strive to defend their resources. Faith-Based Organization (FBO) is an organization with minimal written formal contracts. The bond with the members is a bond with the same values ​​and goals. This research examines the psychological contract of FBO, from the aspects of formation, contribution, and violation. The formation of shared values ​​which becomes the affective commitment of FBO members is specifically discussed because of the uniqueness of the organization with its ideological and religiosity sides. Using the lens of the COR theory, this study sees the psychological contract of the two elements of the FBO, namely members and organizations. This study is a literature review using traditional narrative methods. The results show that there have not been many in-depth studies of the psychological contract on religious organizations (FBO) with religious aspects that characterize the psychology of individuals in it. This study creates new gaps in research related to psychological contracts.
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Placchi, M. "Practical issues in conducting multinational, multicenter trials managed by Contract Research Organisations." European Psychiatry 9, no. 3 (1994): 151–53. http://dx.doi.org/10.1017/s0924933800001152.

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Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.
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6

Goldenberg, Neil A., Alex C. Spyropoulos, Jonathan L. Halperin, Craig M. Kessler, Sam Schulman, Alexander G. G. Turpie, Allan M. Skene, Neal R. Cutler, and William R. Hiatt. "Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model." Blood 117, no. 7 (February 17, 2011): 2089–92. http://dx.doi.org/10.1182/blood-2010-09-308858.

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Abstract Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process.
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7

Balkissoon, Jai, Binh Nguyen, Austin J. Combest, Konstantin Yordanov Stoitchkov, Nikolay Stoyanov, Judy Hsu, and Dirk J. Reitsma. "Managing combination immunotherapy trials from a contract research organization's (CRO's) perspective." Journal of Clinical Oncology 37, no. 8_suppl (March 10, 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 sought to review PPDs experience in combination immunotherapy trials and highlight key challenges, efficiencies, innovative modern trial designs, endpoints and enrollment strategies in a competitive market. Methods: We reviewed IO trials managed by PPD over the past 5 years, information from PPDs Immuno-Oncology Center of Excellence (IOCOE) and Immuno-Oncology Working Group (IOWG) and the current pace of development of IO therapies. Results: PPD has collaborated with multiple sponsors to manage innovative, complex IO trials that push the boundaries of clinical development. Comprehensive planning and risk management strategies steeped in a deep understanding of the trial environment are essential for successful IO protocols. Protocol and trial optimization have been useful to make trials more efficient and less expensive. Conclusions: IO approvals are increasing at a rapid pace and both sponsors and CROs will need to work together to continue to develop innovative trial designs, biomarkers and endpoints that will determine efficacy and tolerability of combination IO therapies. PPDs innovative tools, technology and resources have been useful to help sponsors with enrollment strategies to prevent increasing study timelines and delays in study results. The IO space is pushing the limitations of scientific, technological and operational advances, and we are happy to continue to share our learnings in this ever-evolving landscape.
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8

Jin, Fan, Daniel Tang, Kelly Dong, and Dafang Zhong. "New development and update on China Bioanalysis Forum." Bioanalysis 13, no. 4 (February 2021): 199–201. http://dx.doi.org/10.4155/bio-2020-0312.

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This article provides an update on new development of China Bioanalysis Forum (CBF). CBF became a member association of Chinese Pharmaceutical Association (CPA) at the end of 2019. The official ceremony and first scientific symposium were held in Shanghai on 18 September 2020. The president of Chinese Pharmaceutical Association and representatives from industry, Contract Research Organization (CRO), hospitals and academic institutes attended the ceremony. Seven experts in the field gave presentations on various topics including Drug Metabolism and Pharmacokinetics (DMPK) and bioanalytical support in drug discovery and development as well as experience in Traditional Chinese Medicine research. With the continuous growth of research and development in China, it is well acknowledged that bioanalysis provides critical support for new innovative medicines and generic drug development in the region.
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9

Tayyem, Rabab, Reema Tayyem, Naji Najib, Jaafar Tamimi, and Mukhtar Shihabeddin. "Built-in quality systems in regulated contract research organizations (CRO) conducting bioequivalence studies: a regulatory science perspective." Accreditation and Quality Assurance 13, no. 8 (April 1, 2008): 473–77. http://dx.doi.org/10.1007/s00769-008-0379-5.

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10

Jacobsen, Matt, Arthur Lewis, James Baily, Alain Fraser, Dan Rudmann, and Shane Ryan. "Utilizing Whole Slide Images for the Primary Evaluation and Peer Review of a GLP-Compliant Rodent Toxicology Study." Toxicologic Pathology 49, no. 6 (June 1, 2021): 1164–73. http://dx.doi.org/10.1177/01926233211017031.

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The approach undertaken to deliver a Good Laboratory Practice (GLP) validation of whole slide images (WSIs) and the associated workflow for the digital primary evaluation and peer review of a GLP-compliant rodent inhalation toxicity study is described. The contract research organization (CRO) undertook validation of the slide scanner, scanner software, and associated database software. This provided a GLP validated environment within the database software for the primary histopathologic evaluation using WSI and viewed with the database software web viewer. The CRO also validated a cloud-based digital pathology platform that supported the upload and transfer of WSI and metadata to a cache within the sponsor's local area network. The sponsor undertook a separate GLP validation of the same cloud-based digital pathology platform to cover the download and review of the WSI. The establishment of a fit-for-purpose GLP-compliant workflow for WSI and successful deployment for the digital primary evaluation and peer review of a large GLP toxicology study enabled flexibility in accelerated global working and potential future reuse of digitized data for advanced artificial intelligence and machine learning image analysis.
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11

Scypinski, Stephen, John Baiano, and Theodore Sadlowski. "Available options for doing more with less: laboraory automation as one tool in the arsenal." Journal of Automatic Chemistry 20, no. 3 (1998): 87–89. http://dx.doi.org/10.1155/s146392469800011x.

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Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.
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12

Salian-Mehta, Smita, Jolaine M. Wilson, Holly N. Burr, Abigail Wolf Greenstein, Kathleen Murray, Wanda West, and Nancy Poy. "Supportive care for animals on toxicology studies: An industrial best practices survey conducted by the IQ 3Rs TPS CRO Outreach Working Group." Toxicology Research and Application 5 (January 1, 2021): 239784732199976. http://dx.doi.org/10.1177/2397847321999760.

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Contract Research Organizations (CROs) conducting toxicology studies on behalf of biopharmaceutical sponsors and others routinely provide supportive care for animals to minimize pain and distress on studies. A large number of guidance documents govern the care of experimental animals, however there is currently no uniform approach on the communication between sponsor and their CRO partners in providing a standard definition of and strategies for administering supportive care in toxicity studies. This survey was conducted by the CRO Outreach Working Group (WG), a part of the 3Rs Translational and Predictive Sciences (TPS) Leadership Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), to better understand the provision of supportive care on nonclinical studies. The survey aimed to define supportive care strategies, identify alternatives to supportive care, and understand regulatory feedback and implications about supportive care decisions. The survey was distributed to members of the 3Rs Leadership Group of the IQ Consortium and several CRO partners, representing 35 organizations as potential respondents. The results of the survey from 13 respondents provided positive feedback that helped in highlighting the existing best practices for supportive care. Areas of enhancements identified included greater consistency in the inclusion of sponsor veterinarians on project teams for externalized studies, the timing of initiation of supportive care, and increased sharing of regulatory outcomes. Suggested best practices include creating a plan of action for veterinary care prior to study start, and enhancing information sharing regarding expected toxicities from previous study findings. Improved communication regarding supportive care will pave the way for enhanced 3Rs initiatives, refining the existing animal care paradigm and helping to ensure the most ethical toxicology study designs.
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13

Negrelli, Karina, Tatiana Gotti, Norma Labarthe, Thais Sodré Machado, Regina Albanese, Lucile Maria Floeter Winter, Denise Fantoni, and Greyce Lousana. "O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil." Revista de Educação Continuada em Medicina Veterinária e Zootecnia do CRMV-SP 16, no. 1 (April 16, 2018): 38–44. http://dx.doi.org/10.36440/recmvz.v16i1.37713.

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O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.
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14

Kerr, David, and Kent Koprowicz. "Special considerations of DMCs for oncology studies." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e20071-e20071. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e20071.

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e20071 Background: Data Monitoring Committees (DMCs) are an important component of the clinical trial process. They are charged with reviewing interim data and making recommendations to protect the safety of trial participants and ensure the scientific integrity of the study. Oncologists may be involved with the DMC process in a number of ways – as a DMC member, as an investigator, as a sponsor, or in a regulatory role. This presentation will discuss novel aspects of the DMC review process that are particularly relevant for oncology trials. Methods: The authors are leaders of a Contract Research Organization (CRO) that specializes in providing independent DMC services for government and industry sponsored trials. They have worked with hundreds of unique DMCs and facilitated approximately 1,000 DMC meetings. The proposed methodologies for maximizing the efficiency and thoroughness of DMC reviews are based on extensive experience and well-established principles. Results: Topics that will be covered include: Discrepant trends in PFS vs. OS PFS results that are inconsistent between local and central assessment, or are not yet centrally assessed Co-primary endpoints – OS, PFS, ORR, CR Multiple populations of interest – ITT and a biomarker subgroup Interim analyses – overwhelming efficacy and statistical futility Program-wide DMCs – interpreting trends across multiple studies and logistical details Safety assessment in a study with thousands of AEs – novel graphics and tables Laboratory values and vital signs – novel graphics and tables Multiple comparisons and/or multiple p-values Non-standard tables, listings, figures that are particularly useful for DMC review Open-label studies – immediate withdrawals for those randomized to control arm and other potential biases Single-arm studies – how to interpret safety with no control arm Novel therapies – immune-oncology, CAR-T, small sample sizes CIOMS reports or patient narratives Conclusions: DMCs will perform a more thorough and efficient review of accumulating data upon adapting the guidance provided. A more thorough review will enhance the protection of the trial participants while a more efficient review will allow DMCs to focus their efforts appropriately.
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Kurbegov, Dax, Patricia A. Hurley, David Michael Waterhouse, Grzegorz S. Nowakowski, and Edward S. Kim. "Transforming the site feasibility assessment process for oncology clinical trials." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e14092-e14092. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e14092.

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e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.
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OKRY, FLORENT, PAUL VAN MELE, EDWIN NUIJTEN, PAUL C. STRUIK, and ROCH L. MONGBO. "ORGANIZATIONAL ANALYSIS OF THE SEED SECTOR OF RICE IN GUINEA: STAKEHOLDERS, PERCEPTION AND INSTITUTIONAL LINKAGES." Experimental Agriculture 47, no. 1 (January 2011): 137–57. http://dx.doi.org/10.1017/s001447971000089x.

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SUMMARYThis paper analyses the organization of the rice seed sector in Guinea with the overall objectives to assess how organizational settings affect seed supply to small-scale farmers and to suggest institutional changes that would favour seed service and uptake of varieties. Data were collected in Guinea, West Africa, using focus group discussions with extension workers, farmers, representatives of farmers’ associations, agro-input dealers, researchers and non-governmental organization (NGO) staff, and surveys of 91 rice farming households and 41 local seed dealers. Findings suggest that the current institutional settings and perceptions of stakeholders from the formal seed sector inhibit smallholder farmers’ access to seed. Seed interventions in the past two decades have mainly relied on the national extension system, the research institute, NGOs, farmers’ associations and contract seed producers to ensure seed delivery. Although local seed dealers play a central role in providing seed to farmers, governmental organizations operating in a linear model of formal seed sector development have so far ignored their role. We discuss the need to find common ground and alternative models of seed sector development. In particular we suggest the involvement of local seed dealers in seed development activities to better link the formal and the informal seed systems and improve smallholder farmers’ access to seed from the formal sector.
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17

Waterhouse, David M., R. Donald Harvey, Patricia Hurley, Laura A. Levit, Edward S. Kim, Heidi D. Klepin, Kathryn Finch Mileham, et al. "Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey." JCO Oncology Practice 16, no. 7 (July 2020): 417–21. http://dx.doi.org/10.1200/op.20.00275.

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The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic. There were 32 survey respondents; 14 represented academic programs, and 18 represented community-based programs. Respondents indicated that COVID-19 is leading programs to halt or prioritize screening and/or enrollment for certain clinical trials and cease research-only visits. Most reported conducting remote patient care where possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs); respondents viewed this shift positively. Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services. Interactions with sponsors and CROs about modifying trial procedures were also challenging. The changes in clinical trial procedures identified by the survey could serve as strategies for other programs attempting to maintain their clinical trial portfolios during the COVID-19 pandemic. Additionally, many of the adaptations to trials made during the pandemic provide a long-term opportunity to improve and transform the clinical trial system. Specific improvements could be expanded use of more pragmatic or streamlined trial designs, fewer clinical trial–related patient visits, and minimized sponsor and CRO visits to trial programs.
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Antosova, Zuzana, Nada Podzimkova, Marketa Jiratova, Eva Nedvedova, Guy de Martynoff, David Bechard, Ulrich Moebius, Radek Spisek, and Irena Adkins. "562 SO-C101 induces NK cell cytotoxicity and potentiates antibody-dependent cell cytotoxicity and anti-tumor activity." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (November 2020): A596. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0562.

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BackgroundSO-C101 is a superagonist fusion protein of interleukin (IL)-15 and the IL-15 receptor α (IL-15Rα) sushi+ domain, representing a promising clinical candidate for the treatment of cancer. SO-C101 specifically stimulates natural killer (NK) cells and memory CD8+ T cells with no significant expansion and activation of regulatory T cell compartment.MethodsHuman NK cell proliferation, the expression of NK cell receptors and ADCC activity of human PBMC after stimulation with SO-C101 in vitro in combination with monoclonal antibodies were detected by flow cytometry. The anti-tumor efficacy of SO-C101 in combination with Daratumumab was assessed in a multiple myeloma SCID xenograft mouse model in vivo.ResultsIn this study, we show that SO-C101 induced proliferation and expansion of both major subsets of human NK cells, CD56brightCD16- and CD56dimCD16+. Furthermore, SO-C101 induced expression of the cytotoxic receptors NKp30 and NKG2D whereas no upregulation of the inhibitory receptors CD158a, CD158b and NKG2A was detected. Both NK cell subsets activated by SO-C101 exhibited cytotoxicity towards cancer cells in vitro. Using human PBMCs, we show that SO-C101 potentiated killing of tumor cells induced by several clinically approved therapeutic monoclonal antibodies such as Cetuximab, Daratumumab and Obinutuzumab in vitro. SO-C101 and Daratumumab monotherapy treatment inhibited tumor growth in vivo, however, their combination showed the strongest anti-tumor efficacy. Specifically, sequential administration of Daratumumab, followed by SO-C101 promoted complete tumor regression, compared to partial anti-tumor responses induced by the respective monotherapies.ConclusionsSO-C101 augments the anti-tumor activity of therapeutic antibodies by increasing NK cells mediated antibody-dependent cell cytotoxicity. These results support the evaluation of SO-C101 in combination with monoclonal therapeutic antibodies in clinical studies.Ethics ApprovalThe anti-tumor efficacy studies in mice were approved by the internal ethics board of the respective contract research organization (CRO).
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Kurbegov, Dax, Edward S. Kim, Patricia A. Hurley, and David Michael Waterhouse. "Qualifying sites for oncology clinical trials." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 6619. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.6619.

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6619 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and “no-value” steps that impact clinical trial participation. This project assessed the impact of current sponsor and contract research organizations (CRO) methods to evaluate sites for trials. Methods: A survey was conducted with community- and academic-based trial sites. Samples of feasibility questionnaires (FQs) used by sponsors and CROs were also compiled. An ASCO sponsored multi-stakeholder meeting was held to identify strategies to more effectively assess trial sites. Results: 113 oncology practices (63 community, 50 academic) reported completing 11 FQs and 4 pre-study site visits (PSV) on average per month. On average, each FQ took 4 hours (528 hours/site and 59,664 hours for all respondents, annually) and each PSV took 10 hours (480 hours/site and 54,240 hours for all respondents, annually) to complete. Thus, the total staff hours required to complete site feasibility assessments was 113,904 annually. Respondents reported that content in both FQs (82%) and PSVs (91%) was redundant to information previously provided and FQs were redundant between different sponsors (86%). The 42 sample FQs had a median 45 questions (range 13 to 96). Respondents noted that sponsors/CROs provided insufficient study documentation to accurately complete FQs. It took 7 months on average from first contact to first patient enrolled. Respondents also provided feedback about standardizing and streamlining site qualification processes. Conclusions: The current methods of assessing site feasibility for clinical trials poses tremendous burden on site resources and is not sustainable. New methods are needed that standardize, harmonize, and streamline criteria and site assessments. Such changes will reduce burden and costs for all stakeholders, and will expedite and increase patient enrollment onto clinical trials.
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Arun Tej, P., and S. Revathi. "Contract Research Organization." Global Journal for Pharma and Allied Sciences 1, no. 5 (September 25, 2020): 23–26. http://dx.doi.org/10.47583/gjfpas.2020.v01i05.004.

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21

Norkin, Judith. "Shopping for a Contract Research Organization." Bio/Technology 12, no. 5 (May 1994): 526–28. http://dx.doi.org/10.1038/nbt0594-526.

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22

Gosselin, Sylvie J., Bernard Palate, George A. Parker, Jeffery A. Engelhardt, Jerry F. Hardisty, Kevin S. McDorman, Pierre A. Tellier, and Lee R. Silverman. "Industry–Contract Research Organization Pathology Interactions." Toxicologic Pathology 39, no. 2 (January 26, 2011): 422–28. http://dx.doi.org/10.1177/0192623310395331.

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Cervo, Silvia, Paolo De Paoli, Tiziana Perin, Vincenzo Canzonieri, and Agostino Steffan. "Cost-Effective Organization of an Institutional Human Cancer Biobank in a Clinical Setting: CRO-Biobank Experience Toward Harmonization." International Journal of Biological Markers 30, no. 2 (April 2015): 243–51. http://dx.doi.org/10.5301/jbm.5000138.

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This report describes the organization of the Biobank of the CRO Aviano National Cancer Institute, Aviano (CRO- Biobank), Italy, implemented as a structured facility dedicated to collecting human biological samples. It describes a particular disease-specific biobank and the integration of a research biobank in a clinical setting. The CRO-Biobank's mission is rooted in supporting and implementing cancer research, with its main focus on optimizing technical and quality processes, while also investigating ethical, legal and IT topics. The CRO-Biobank has implemented processes aimed at guaranteeing the safety of the providers, protecting patient privacy and ensuring both the traceability and quality of its samples. Our 8 years of experience allow us to offer insights and useful suggestions that may solve theoretical and practical issues that can arise when starting up new biobanks or developing existing biobanks further.
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Panchatcharam, Murugan, and Sravanthi Lakshmi Mukku. "COVID-19 challenges in clinical trials." International Journal of Basic & Clinical Pharmacology 10, no. 6 (May 25, 2021): 769. http://dx.doi.org/10.18203/2319-2003.ijbcp20212092.

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Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).
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Arora Nageen, Arora Neha. "CONTRACT RESEARCH ORGANIZATION AND ITS GROWTH CRITERIA." IOSR Journal of Pharmacy (IOSRPHR) 2, no. 2 (January 2012): 182–83. http://dx.doi.org/10.9790/3013-0220182183.

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Gould, A. Lawrence, Adam B. Polis, and Charles L. Bernd. "The Merck Internal Contract Research Organization Project." Drug Information Journal 34, no. 2 (April 2000): 433–45. http://dx.doi.org/10.1177/009286150003400212.

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Simunovic, Nicole, Sheila Sprague, and Mohit Bhandari. "Finding a Contract Research Organization for Your Research Trial." Journal of Long-Term Effects of Medical Implants 19, no. 3 (2009): 241–45. http://dx.doi.org/10.1615/jlongtermeffmedimplants.v19.i3.100.

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Whang, SangMin, and TaeYon Kwon. "The secrets behind talents companies crave." Korean Journal of Industrial and Organizational Psychology 25, no. 1 (February 28, 2012): 59–83. http://dx.doi.org/10.24230/kjiop.v25i1.59-83.

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This research is aimed at identifying the features of ‘talented candidates’ sought after by professional human resources and recruiters in major companies. First, this research investigated how they perceive potential candidates by examining various standards with which candidates are evaluated in recruiting process. Various perceptions of ‘talented candidates’ was summarized into a questionnaire of 99 Q statements. The participants were then responded into ‘who you want to recruit’ and ‘who you don't want to recruit.’ The responses were subsequently subdivided by factor analysis employing the Q- Methodology. Wide perception of people’s for ‘talented candidate’ can be epitomized into a person who generates hard results, leads co-workers, and remains loyal to the organization with a proper dose of balance in professional life. They all seemed to embody the properties of a ‘passionate CEO’, an ‘eminent field expert’, or a ‘trophy-winning consultant’. To the contrary, the images of candidates unwanted by companies could be associated with the features of workers being laid off. These were a ‘couch potato with a sigh’, a ‘barely-surviver’ or ‘greedy-for-security’. Further subdividing those wanted and unwanted by companies leads to 6 categories of talents. Those wanted by companies were categorized into: ‘earlier company founder’, ‘corporate-fitter’, and ‘contract-based’. Those unwanted by companies were categorized into: ‘always-being-sacrificed’, ‘spec-builder’, and ‘need-based employee’. The categorization made clear there is a difference between talents companies crave and talents wanting to be hired, which reveals a dichotomy between a candidate and a recruiter. In the case of professional HR officials and recruiters, it was clear that a candidate with certain predispositions at company side for company were wanted more.
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Mirowski, Philip, and Robert Van Horn. "The Contract Research Organization and the Commercialization of Scientific Research." Social Studies of Science 35, no. 4 (August 2005): 503–48. http://dx.doi.org/10.1177/0306312705052103.

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Tran, Huy Phuong. "How authentic leadership promotes individual knowledge sharing: viewing from the lens of COR theory." Management & Marketing. Challenges for the Knowledge Society 14, no. 4 (December 1, 2019): 386–401. http://dx.doi.org/10.2478/mmcks-2019-0027.

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Abstract Fostering knowledge sharing has been one of the most vital tasks for organizations in the knowledge based economy. Thus, investigating the antecedents of knowledge sharing behavior is of great interest to both academics and practitioners. The impact of leadership on knowledge sharing has been reported in the literature. However, the direct and indirect impacts of authentic leadership on knowledge sharing is under-researched. Furthermore, because knowledge is an individual resource, knowledge sharing can be investigated in the light of the conservation of resource theory. This study applies conservation of resource theory to examine the influence of authentic leadership on knowledge sharing with relational psychological contract and organizational based self-esteem as mediators. Data collected from survey using questionnaire were used to test the hypotheses in a quantitative research design. Structural equation modelling (SEM) techniques are applied for data analysis. The results showed that authentic leadership positively and significantly influence individual knowledge sharing. Furthermore, relational psychological contract and organizational based self-esteem have been found to mediate the above relationship. Discussion of research findings, theoretical and practical implications are also detailed. Finally, the study outlines limitations of research and provides directions for further knowledge sharing studies.
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Kitchen, Douglas B. "Computer-aided drug discovery research at a global contract research organization." Journal of Computer-Aided Molecular Design 31, no. 3 (November 1, 2016): 309–18. http://dx.doi.org/10.1007/s10822-016-9991-3.

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Mackintosh, Douglas R., and Vernette J. Zepp. "Getting a Better Deal: Unbundled Contract Research Organization Prices." Drug Information Journal 29, no. 4 (October 1995): 1175–80. http://dx.doi.org/10.1177/009286159502900414.

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Premkumar, Noel, Stephen Lowes, James Jersey, Fabio Garofolo, Isabelle Dumont, Robert Masse, Betty Stamatiou, et al. "Formation of a Global Contract Research Organization Council for Bioanalysis." Bioanalysis 2, no. 11 (November 2010): 1797–800. http://dx.doi.org/10.4155/bio.10.165.

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Mensah, Godson K., and Werner D. Gottwald. "Enterprise risk management: Factors associated with effective implementation." Risk Governance and Control: Financial Markets and Institutions 6, no. 4 (2016): 175–206. http://dx.doi.org/10.22495/rcgv6i4c1art9.

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Risk management is undergoing a great change, as organizations shift from the traditional and compartmental to an enterprise wide approach. Consequently, enterprise risk management (ERM) is gaining global attention among risk management professionals and academics. The demand for the adoption of ERM has led to several companies embracing it, yet its implementation has become challenging. Research shows that ERM approach emphasizes a holistic approach for assessing and evaluating the risks that an organization faces as against the “silo” approach of the traditional methods. The extant literature shows that through the reduction of the risk that an organization faces, ERM is capable of improving the performance and value. The study used a non-experimental correlational approach to explore the relationship between the presence of a chief risk officer (CRO) and an audit committee (AC), and the support of top management (TM) in relation to the implementation of ERM. A survey instrument was provided to self-identified risk-management professionals who are members of Survey Monkey Audience Service database. The target sample frame requested for analysis using a power of .95 was (n = 119). However, the final number analyzed was (n = 134). Frequencies and percentages were conducted on the demographic survey items and regression and correlational analyses were also performed. The study findings show that there was a significant relationship between the role of a CRO, the presence of an AC, and the support of TM and the level of ERM deployment. The study also found significant correlations between management support level and CRO, and AC. In addition, a much strong positive correlation was noted between the presence of a CRO and an AC.
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Mazur, Karolina. "The dynamics of psychological contract between employee and organization. The analysis of selected factors." Management 16, no. 1 (May 1, 2012): 51–64. http://dx.doi.org/10.2478/v10286-012-0004-x.

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The dynamics of psychological contract between employee and organization. The analysis of selected factors The main purpose of this paper was the examination if the psychological contract between an employee and organization has a dynamic character and how the age and experience progress influences the contract in terms of contract content, values offered by employees and the contract breach. The paper consists of own research findings of the author. The group of 140 employees from high-tech industry were examined in period of 2010-2011. There was used a χ2 test in assessment of assumed relations. The research findings proved that the conditions of psychological contract changed with age of employee and his or her stage in the workplace. It refers to both parts of the contract. Values expected and values offered by employee evolves. The age and stage in the workplace change are also connected with change of employee perception of the type of contract breach. The research findings demonstrated that psychological contract is dynamic phenomenon.
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Sukmana, Uza. "PENGARUH KONTRAK PSIKOLOGIS DAN MOTIVASI KERJA TERHADAP KOMITMEN ORGANISASI GURU SMK NEGERI KABUPATEN LAMPUNG BARAT." Jurnal Manajemen Pendidikan 7, no. 2 (December 1, 2016): 1328. http://dx.doi.org/10.21009/jmp.07204.

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The objective of this research is to obtain information about the effect of psychological contract and job motivation on teacher organization commitmen. It was quantitative research with survey method in SMK Negeri Kabupaten Lampung Barat.The research was conducted to all teacher of SMK Negeri Kabupaten Lampung Barat by using a survey method with path analysis applied in testing hypothesis. The number 154 teachers as sample was selected by using Slovin formula.The research conlude: (1) There is a direct positive effect of psychological contract on organization commitmen. (2) There is a direct positive effect of job motivation on organization commitmen. (3) There is a direct positive of psychological contract on job motivation.
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Zafar, Afnan. "Reasons for outsourcing innovations and its effect on firm performance: Evidence from highly innovative firms from twenty countries." Technium Social Sciences Journal 13 (October 14, 2020): 305–19. http://dx.doi.org/10.47577/tssj.v13i1.1705.

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Innovative products have become crucial as firms vie for consumer attention in a saturated market. One important strategy is the use of external innovation providers. This study investigates reasons for outsourcing innovations (OI) and their relationship with firms’ performance. The results should assist firms in ascertaining how the reasons for OI affect firm performance. First, the conceptual framework of reasons for OI and related firm performance was synthesized from the open innovation literature. Then, highly innovative firms from twenty countries were surveyed and analysed using statistical tools. The results provided support for a conceptual framework with a positive relationship between five reasons for OI and firms’ overall performance. An implication for managers is that, if Contract Research Organisation (CRO) country’s environment is the only reason for entering into an OI contract, it might not be a good decision in terms of the respective firms’ overall performance.
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Glass, Harold E. "Investigator Attitudes towards Participation in Contract Research Organization-Managed Clinical Studies." Pharmaceutical Medicine 23, no. 2 (April 2009): 85–90. http://dx.doi.org/10.1007/bf03256754.

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Marciniak, Magdalena. "Growing by Sharing - Story of Ryvu and Selvita." Technology Transfer and Entrepreneurship 7, no. 1 (June 4, 2020): 33–47. http://dx.doi.org/10.2174/2213809907666200320085519.

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Ryvu Therapeutics and Selvita originated in 2007, a time when drug discovery in Poland was still not pursued by industrial enterprises. For many years, both entities operated one company and were known under a common name Selvita S.A., combining their efforts on both innovative small-molecule therapeutics for oncology and expertise in Contract Research Services (CRO). Following more than a decade of such a hybrid business model, Selvita established a strong position in the field of drug discovery and built trust among partners, clients, and investors globally. This encouraged the leaders of the company to separate the two divisions into fully autonomous units, which in fact, had already been operating quite independently and both were successful in diverse areas of drug discovery activities. At the beginning of October 2019, two new companies were established and both parts were given independence and more opportunities for growth. Discovery and development engine was named as Ryvu Therapeutics, and the CRO part of the company remained with the name Selvita. To reach this stage, both the divisions went through an interesting journey together, supporting and strengthening each other for the benefit of both.
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Noorderhaven, Niels G. "The Problem of Contract Enforcement in Economic Organization Theory." Organization Studies 13, no. 2 (April 1992): 229–43. http://dx.doi.org/10.1177/017084069201300204.

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Recently, economists have directed attention to the phenomenon of organization. An important difference between the newly developed economic theories of organization, such as for example agency theory, and sociological theories of organization is the fact that economists explicitly employ an individual utility maximization assumption. In this paper, it is reasoned that this assumption, if used as in agency theory, entails logical inconsistencies if we try to explain the existence of the kind of agreements that purportedly form the basis of organiza tions. However, if the condition of uncertainty — to which agency theorists merely pay lip—service — is taken seriously, the observed inconsistencies can be reconciled. A classificatory scheme of four 'sources of obligation' is proposed for the analysis of the basis of agreements. Taking all four sources into consideration in the analysis of organizational agreements can help to avoid one-sided attention to, for example, formal, legally enforceable agreements. The findings of empirical research suggest that two basic dimensions lie at the root of the proposed classifi catory scheme. Further research is needed to check this supposition and its implications.
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Estreder, Yolanda, Thomas Rigotti, Inés Tomás, and José Ramos. "Psychological contract and organizational justice: the role of normative contract." Employee Relations: The International Journal 42, no. 1 (January 6, 2020): 17–34. http://dx.doi.org/10.1108/er-02-2018-0039.

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Purpose The purpose of this paper is to examine perceptions of the psychological contract (PC) simultaneously at the individual level (fulfillment of obligations by the organization and PC violation) and the organizational level (normative contract), and their relationship with employees’ evaluations of organizational justice. Based on justice and information processing approaches, the hypothesis is that normative contract has an effect on employees’ perceptions of organizational justice, and also moderates the relationship between PC violation and organizational justice. Design/methodology/approach Multilevel modeling was employed with a multinational sample of 5,338 employees nested in 214 companies. Findings Findings showed that beyond the positive effect of fulfillment of obligations by the organization, PC violation has a strong negative effect on organizational justice. In addition, normative contract has a positive effect on organizational justice, showing that when shared perceptions of normative contract are higher, then the organizational justice perceptions of employees are also higher. Furthermore, the normative contract moderated the relationship between PC violation and organizational justice, showing that the negative relationship of PC violation with organizational justice was stronger when the normative contract was higher. Practical implications Findings suggest that normative contract has effects on organizational justice, and that PC violation had more negative effects on employees’ perceptions of organizational justice perceptions when colleagues’ shared perceptions of fulfillment were higher. This means that social context (shared perceptions in an organization about the PC) has effects on individual perceptions of organizational justice. Companies need to pay attention to detrimental effects on employees who perceive a worse PC than their colleagues do. Originality/value The study extends the current research by demonstrating that employee–employer exchanges are not limited to individual level effects because shared perceptions of PC fulfillment (normative contract) also have relevant effects on employees’ perceptions of organizational justice.
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Neal, Harold. "The Contract Research Organization Perspective: Audits in Central and Eastern European Countries." Drug Information Journal 35, no. 2 (April 2001): 475–80. http://dx.doi.org/10.1177/009286150103500216.

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Goode, Jackie. "Research Identities: Reflections of a Contract Researcher." Sociological Research Online 11, no. 2 (July 2006): 40–49. http://dx.doi.org/10.5153/sro.1389.

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This paper examines the institutional identity formation of contract research staff in the context of the Taylorisation of research knowledges. The author has been a contract researcher for many years, after initially training and practising as a Probation Officer. She makes links between her social work training, and her current practice as a qualitative researcher. Drawing on her experience of working on a variety of different projects, at a number of different institutions, and providing illustrative examples from projects in sociology, social policy, health, and education, she reflects on the implications of the current social organization of academic research both for professional research practice and for researcher identity. There is a paradox in the way that contract research staff accrue a wealth of experience of how research is organised and conducted in different contexts, a repertoire of skills, and a vast volume of various kinds of ‘data’, whilst remaining vulnerable and marginalized figures within the academy, with few opportunities for professional development and advancement. She outlines a number of strategies she has employed in the preservation of the ‘research self’, and concludes by suggesting that the academy has much to learn about the effective management of ‘waste’, as embodied by researchers’ selves and their data, consequent upon the Taylorisation of research work.
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Bhattarai, Ganesh, Dipendra Karki, and Rewan Kumar Dahal. "Psychological Contract Breach and Organizational Deviance Behaviour: Mediating Role of Professional Commitment." Nepal Journal of Multidisciplinary Research 3, no. 3 (December 31, 2020): 34–50. http://dx.doi.org/10.3126/njmr.v3i3.34883.

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This study was carried out to measure the direct impact of employees’ psychological contract breach on organizational deviance behavior and professional commitment, direct impact of professional commitment on organizational deviance behavior, and mediating role of professional commitment in the relationship between psychological contract breaches to organizational deviance behavior. As the respondents, 426 employees working in Nepalese non-profit making organization (i.e. international non-government organization working in Nepalas well as national level non-government organization) were surveyed. were drawn from the analysis of crosses sectional perceptual data adopting quantitative research method, deducting reasoning approach and positivist research philosophy. Regression analysis, after the confirmatory factor analysis, revealed that (a) employee’s psychological contract breach was positively associated with organizational deviance behavior, (b) employees psychological contract was negatively associated with professional commitment, (c) employees’ professional commitment was negatively associated with organizational deviance behavior, and (d) professional commitment mediated the relationship of psychological contract breach to organizational deviance behavior. Moreover, regarding effect size, the direct effect size of psychological contract breach to predict organizational deviance behavior was .86, and an indirect effect through professional commitment was -.12.Based on the study's conclusion, numbers of theoretical implication and practical implications are suggested.
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Chong Ju Choi. "Contract Enforcement Across Cultures." Organization Studies 15, no. 5 (September 1994): 673–82. http://dx.doi.org/10.1177/017084069401500502.

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The importance of contract enforcement and formal and informal agreements has recently become an increasingly researched area in management. A major part of this research is the difference between the sociological and management approach and that of the recent developments in organization economics. Recent works in this area include Barney (1990), Eisenhardt (1989) and Noord erhaven (1992). The main purpose of this paper is to try and develop the ideas in these works further with respect to agreements and non-legal forms of contracts. We do this by comparing systems of cooperation and agreements in Eastern Europe, East Asia and Southeast Asia.
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José Chambel, Maria. "Does the fulfillment of supervisor psychological contract make a difference?" Leadership & Organization Development Journal 35, no. 1 (February 25, 2014): 20–37. http://dx.doi.org/10.1108/lodj-03-2012-0031.

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Purpose – The purpose of this paper is to set out to analyze the supervisor psychological contract as a new psychological contract focus. Furthermore, the relationship between this psychological contract and the organizational psychological contract is compared in the prediction of job satisfaction and organizational affective commitment among a sample of traditional (in-house) and temporary agency workers. Design/methodology/approach – The hypotheses were tested with multiple group analyses in a sample of 444 Portuguese call center workers: 215 were in-house and 229 were temporary agency workers. Findings – Results confirmed that workers, regardless of their status, distinguished these two foci of psychological contract. However, for temporary workers, the supervisor psychological contract partially mediated the relationship between the organizational psychological contract and attitudes; while for in-house workers the organizational psychological contract was relevant to explain job satisfaction and the two foci of the psychological contract related independently to workers’ affective commitment toward the organization. Research limitations/implications – The study is limited due to the nature of the sample (call center sector where temporary agency and in-house workers received similar opportunities and treatment) and the lack of a longitudinal design. Practical implications – An important implication of this research is that employers should assume the relevance of the supervisor for temporary agency workers. The social exchange between them and the host organization occurs in part through his/her actions. Originality/value – Although supervisor psychological contract has been acknowledged, as far as the authors know there are no empirical studies that support its existence or analyzes its relevance in worker-organization relationships.
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Wiedey, Klaus D., and Facharzt für Klinische Pharmakologie. "Auditing under Multiple Standard Operating Procedures: The View of a Contract Research Organization." Drug Information Journal 28, no. 4 (October 1994): 1167–71. http://dx.doi.org/10.1177/009286159402800442.

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Jonvallen, Petra. "Compliance revisited: pharmaceutical drug trials in the era of the contract research organization." Nursing Inquiry 16, no. 4 (December 2009): 347–54. http://dx.doi.org/10.1111/j.1440-1800.2009.00455.x.

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Wolfs, Marion, Amy Bambic, Barbara Spurden-de Lange, Kristy Galante, Raquel Sanchez Plaza, Crona O’Conallain, Graciela Racaro, Martin Giblin, and Sina Djali. "Risk-Based Monitoring: Key Conditions in Collaboration Between Contract Research Organization and Sponsor." Therapeutic Innovation & Regulatory Science 53, no. 4 (July 2019): 512–18. http://dx.doi.org/10.1177/2168479018793883.

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Dries, Nicky, Anneleen Forrier, Ans De Vos, and Roland Pepermans. "Self-perceived employability, organization-rated potential, and the psychological contract." Journal of Managerial Psychology 29, no. 5 (July 8, 2014): 565–81. http://dx.doi.org/10.1108/jmp-04-2013-0109.

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Purpose – The purpose of this paper is to study the relationship between self-perceived employability resources and perceived psychological contract (PC) obligations. To examine the extent to which organizational ratings of potential, through their “signaling” function, might serve as a buffer between employability and PC perceptions that are undesirable from an employer's point of view. Design/methodology/approach – Both self-report data (i.e. self-perceived employability resources and perceived PC obligations) and data reported by the HR departments of the participating organizations (i.e. organizational ratings of potential) were collected in a case-control design (n=103). Findings – Self-perceived employability resources are not related to lower intentions to stay with one's current employer. High-potential employees did not perceive themselves as particularly obliged to reciprocate their organizations’ additional investments in them by expressing longer term loyalty, or a higher performance level. Practical implications – Organizations should not be hesitant to assist their employees in enhancing their employability resources. In addition, they should engage in deliberate PC building with their high-potential employees so as to align their perceived PC obligations with the organizational agenda. Originality/value – The relationship between self-perceived employability resources and perceived PC obligations has been underexamined; hardly any PC research has taken organizational variables into account; hardly any research exists on the psychological implications of being identified as a high potential; and the study draws both on self-report data and data reported by the HR departments of the participating organizations.
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