Evolving risk based monitoring scenario and change management associated with it


  • Neha Sharma Manager/Subject Matter expert, Risk Based Monitoring, Tata Consultancy Services, Mumbai, Maharashtra, India




Risk based monitoring, Change management, Clinical project managers, Site monitoring, Recommendations for successful implementation / dealing with change, Lead data managers


Clinical research and drug development is evolving continuously resulting in pharma companies looking for newer ways of getting drugs faster to the market. Managing clinical costs and coping with major regulatory hurdles poses challenges of finding ways to do more with a small budget. The Food and Drug Administration (FDA) guidance for industry on “risk based approach to monitoring”, TransCelerate Biopharma INCs “risk based monitoring methodology position paper” provides guidance, recommendations and methodologies for conducting risk based monitoring (RBM). However, limited experience in the implementation of these methodologies poses questions on practical challenges that pharmaceutical companies are either already facing or will face during the implementation of these recommendations. This paper describes the evolution of RBM strategies and discusses the complexities that clinical research organizations (CROs) and service providers could face while implementing RBM. This paper also suggests how pharma companies may have to adapt their organization to this new model by highlighting changes in roles and responsibilities of relevant stakeholders including site investigators, site monitors and lead data managers. A few suggestions for ensuring smooth change management have also been proposed for each stakeholder.


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Food and Drug Administration. Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring. http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf . Accessed March 16, 2015.

TransCelerate BIOPHARMA INC. Position Paper: Risk-Based Monitoring Methodology. http://www.transceleratebiopharmainc.com/ wp-content/ uploads/ 2013/ 10/ TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf. Accessed March 16, 2015.

European Medicines Agency. Reflection paper on risk based quality management in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf. Accessed March 16, 2015.






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