Agile Transformation in Clinical Research
We need well designed clinical trials in order to manage different health issues and deliver quality vaccines and drugs to patients. The whole process starts with the phase I of the trial, followed by phases II and III, after which the documentation is presented to the regulatory body, which reviews...
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| Format: | Article |
| Language: | English |
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Serbian Project Management Association - IPMA Serbia
2018-11-01
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| Series: | European Project Management Journal |
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| Online Access: | http://media.epmj.org/2018/11/8-Agile-Transformation-in-Clinical-Research-1.pdf |
| _version_ | 1818891569064837120 |
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| author | Katarina B. Pavlović Ivana Berić Ljiljana Berezljev |
| author_facet | Katarina B. Pavlović Ivana Berić Ljiljana Berezljev |
| author_sort | Katarina B. Pavlović |
| collection | DOAJ |
| description | We need well designed clinical trials in order to manage different health issues and deliver quality vaccines and drugs to patients. The whole process starts with the phase I of the trial, followed by phases II and III, after which the documentation is presented to the regulatory body, which reviews the data presented, going into the phase IV if required. The process ends with a license to market being issued. Trials are expensive, time consuming and with uncertain outcomes. The old ways of managing clinical trials do not give satisfactory results any more. It seems that the change is needed more than ever before. Clinical research organizations that manage clinical trials, being a part of a highly innovative industry, need innovation themselves. They need to adapt in order to stay competitive. In this paper, it is presented, according to the literature review, that a possible way to undergo adaptation is through agile transformation. |
| first_indexed | 2024-12-19T17:42:53Z |
| format | Article |
| id | doaj.art-dcc727289813434ab299b948baa20dd1 |
| institution | Directory Open Access Journal |
| issn | 2560-4961 |
| language | English |
| last_indexed | 2024-12-19T17:42:53Z |
| publishDate | 2018-11-01 |
| publisher | Serbian Project Management Association - IPMA Serbia |
| record_format | Article |
| series | European Project Management Journal |
| spelling | doaj.art-dcc727289813434ab299b948baa20dd12022-12-21T20:12:10ZengSerbian Project Management Association - IPMA SerbiaEuropean Project Management Journal2560-49612018-11-01816570https://doi.org/10.18485/epmj.2018.8.1.8Agile Transformation in Clinical ResearchKatarina B. Pavlović0Ivana Berić1Ljiljana Berezljev2Faculty for Project and Innovation Management, Educons University, SerbiaFaculty for Project and Innovation Management, Educons University, SerbiaFaculty for Project and Innovation Management, Educons University, SerbiaWe need well designed clinical trials in order to manage different health issues and deliver quality vaccines and drugs to patients. The whole process starts with the phase I of the trial, followed by phases II and III, after which the documentation is presented to the regulatory body, which reviews the data presented, going into the phase IV if required. The process ends with a license to market being issued. Trials are expensive, time consuming and with uncertain outcomes. The old ways of managing clinical trials do not give satisfactory results any more. It seems that the change is needed more than ever before. Clinical research organizations that manage clinical trials, being a part of a highly innovative industry, need innovation themselves. They need to adapt in order to stay competitive. In this paper, it is presented, according to the literature review, that a possible way to undergo adaptation is through agile transformation.http://media.epmj.org/2018/11/8-Agile-Transformation-in-Clinical-Research-1.pdfadaptive clinical trialsagile transformation |
| spellingShingle | Katarina B. Pavlović Ivana Berić Ljiljana Berezljev Agile Transformation in Clinical Research European Project Management Journal adaptive clinical trials agile transformation |
| title | Agile Transformation in Clinical Research |
| title_full | Agile Transformation in Clinical Research |
| title_fullStr | Agile Transformation in Clinical Research |
| title_full_unstemmed | Agile Transformation in Clinical Research |
| title_short | Agile Transformation in Clinical Research |
| title_sort | agile transformation in clinical research |
| topic | adaptive clinical trials agile transformation |
| url | http://media.epmj.org/2018/11/8-Agile-Transformation-in-Clinical-Research-1.pdf |
| work_keys_str_mv | AT katarinabpavlovic agiletransformationinclinicalresearch AT ivanaberic agiletransformationinclinicalresearch AT ljiljanaberezljev agiletransformationinclinicalresearch |