PROCESS MODEL OF THE TRIAL SITE QUALITY MANAGEMENT SYSTEM

Authors

  • ZUPANETS KO National University of Pharmacy
  • YE DOBROVA V

Abstract

The necessity of ensuring the implementation of planned objectives concerning quality, costs and timing of clinical trials (CT) in a modern complex
and changing environment determines the importance of a systematic approach to CT quality management. Thus, the issues of designing based on
the process approach quality management system (QMS) have become an actual task at trial site. To build a process model of a trial site QMS we used
Integration Definition Function Modeling methodology. General approaches to the process model of QMS have been developed, its core processes have
been explicated, its input, outputs, and their interrelation according to the application of ISO 9001:2015 have been implemented. The main process
chart which includes five base CT processes has been designed. The consistency of these processes has been substantiated and described with the
general framework for QMS implementation at trial site provided. Our model can be used at trial sites as a framework for designing QMS in the process
of ISO standards implementation.
Keywords: Trial site, Quality management system, Process model.

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References

. Bhatt A. Quality of clinical trials: A moving target. Perspect Clin Res

;2(4):124-8.

Adams CP, Brantner VV. Estimating the cost of new drug development:

Is it really $802 million dollars? Health Aff (Millwood) 2006;25:420-8.

Clinical Trial Conduct in Emerging Markets. Available from: http://

www.covance.com/con-tent/dam/covance/assetLibrary/presentations/

Covance%202014%20Emerging%20Markets.%20Presentation.pdf.

Cost of Developing a New Drug. Tufts Center for the Study of Drug

Development. Available from: http://www.csdd.tufts.edu/news/

complete_story/pr_tufts_csdd_2014_cost_study.

Kleppinger CF, Ball LK. Building quality in clinical trials with use of a

quality systems approach. Clin Infect Dis 2010;51 Suppl 1:S111-6.

Zupanets KO, Dobrova VY, Proskurnya YM. Science justification of

combined managementsystem of clinical trialon clinical site. Qual

Econ Qual Assur Pharm 2015;4:60-6.

Guidance for Industry E6 Good Clinical Practice. Tripartite Harmonized

ICH Guideline. CPMP/ICH/135/95/Step5. p. 59.

Examination of Clinical Trial Costs and Barriers for Drug Development.

Available from: http://www.aspe.hhs.gov/sp/reports/2014/

ClinicalTrials/rpt_erg.pdf.

Farrell B. A Guide to Efficient Trial Management. In: Farrell B,

Kenyon S, editors. On Behalf of the UK Trial Managers’ Network.

Available from: http://www.tmn.ac.uk/guide.htm.

Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials

;11:78.

Alemayehu DA, Alvir J, Chappell PB, Knirsch CA. A quantitative

approach to enhancing risk assessment and mitigation in drug

development. Appl Clin Trials 2012;21(4):33-5.

Risk-Based Monitoring: Reduce Clinical Trial Costs While Protecting

Safety and Quality. Available from: http://www.pwc.se/sv_SE/se/

bioteknik/assets/risk–based–monitoringreduce–clinical–trial–costs–

while–protecting–safety–and–quality.pdf.

Sax A, Keegan M, White D, Turner JR. Risk-based monitoring: The

new regulatory landscape, and conjectures on the future of clinical trial

execution. J Clin Stud 2012;4(5):26-33.

Torche F. The practical implementation of risk-based monitoring. Appl

Clin Trials. Available from: http://www.appliedclinicaltrialsonline.

com/practicalimplementationriskbasedmonitoring.

Cost of Developing a New Drug. Tufts Center for the Study of Drug

Development. Available from: http://www.csdd.tufts.edu/news/

complete_story/pr_tufts_csdd_2014_cost_study.

Dumas M, La Posa M, Reijers H. Fundamentals of Business Process

Management. Berlin: Springer; 2013.

Rosen DH, Johnson S, Kebaabetswe P, Thigpen M, Smith DK. Process

maps in clinical trial quality assurance. Clin Trials 2009;6(4):373-7.

ISO 9001: 2008 Quality Management Systems. Requirements.

Standard; 2008.

Graham D. A Practical Guide to Quality Management in Clinical Trial

Research. Boca Raton: CRC Press; 2006.

CTTI Quality by Design Workshop Project. Draft Working

Group Document. Available from: http://www.ctti–clinicaltrials.org/

files/documents/QRMworkshop–PrinciplesDoc.pdf.

Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical

Trials. 3

ed. New-York: Springer –Verlag; 1998.

Michael J, Howley PA, Malamis P. The quality of clinical trials. Appl

rd

Clin Trials. Available from: http://www.appliedclinicaltrialsonline.

com/print/285772?page=full.

Published

01-05-2016

How to Cite

KO, Z. ., and Y. D. V. “PROCESS MODEL OF THE TRIAL SITE QUALITY MANAGEMENT SYSTEM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 9, no. 3, May 2016, pp. 225-8, https://mail.innovareacademics.in/journals/index.php/ajpcr/article/view/11127.

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