Critical utility of e-solutions in risk based monitoring

Pranjal R. Chaturvedi

Abstract

As the clinical trial industry is evolving from a traditional 100% SDV (source data verification) approach to reduced SDV & Centralized Monitoring by applying a risk based monitoring (RBM) approach, hence forth leveraging of e-Solutions and real time data integrations would be critical in RBM. Technological considerations are critical to collect data real time to assess, monitor and mitigate risk in compliance with Good Clinical Practices. This article will examine the importance of e-Solutions and real time analytics in alignment with various systems for developing an effective RBM strategy.

Keywords

Source data verification, Risk based monitoring, Good clinical practices

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References

Guidance for Industry. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring,2013. Available at http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf. Accessed 10 January 2016.

Position Paper: Risk-Based Monitoring Methodology, 2013. Available at http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf. Accessed 15 January 2016.

Beyond SDV: Enabling Holistic, Strategic Risk-Based Monitoring, 2015. Available at http://www.oracle.com/us/industries/health-sciences/hs-enabling-strategic-risk-wp-2165355.pdf. Accessed 5 May 2016.

Challenges and benefits of EDC adoption, 2013. Available at http://www.clincapture.com/blog/chall

enges-and-benefits-of-edc-adoption/. Accessed 19 April 2016.

Gupta A. Taking the 'Risk' out of risk-based monitoring. Perspect Clin Res 2013;4:193-5.

Benefits and Challenges of EDC Adoption, 2014. Available at http://www.slideshare.net/Clinovo/benefits-and-challenges-of-edc-adoption-34048655. Accessed 15 March 2015.

Slizgi B, Franco R, Hrone M. Higher Quality at Lower Cost: The Benefits of Portfolio-Wide Predictive Analytics in Clinical Trial Monitoring. Applied clinical trials. 2013. Available at http://www.appliedclinicaltrialsonline.com/higher-quality-lower-cost-benefits-portfolio-wide-predictive-analytics-clinical-trial-monitoring. Accessed 25 February 2016.

Risk-based Monitoring Strategies for Improved Clinical Trial Performance, 2013. Available at http://www.cognizant.com/InsightsWhitepapers/Risk-based-Monitoring-Strategies-for-Improved-Clinical-Trial-Performance.pdf. Accessed 5 June 2016.

Transform clinical development through advances in risk based monitoring, 2015. Available at http://www.quintiles.com/library/whitepapers/transform-clinical-development-through-advances-in-risk-based-monitoring#pdf. Accessed 10 May 2016.

An Innovative Approach to Address Risk Based Monitoring, 2016. http://www.covance.com/industr

y-solutions/drug-development/by-phase/risk-based-monitoring.html. Accessed 15 July 2016.

Burgess M. Less is More: Risk-Based Monitoring of Site Performance, 2013. Available at https://www.

iconplc.com/technology/iconik/Less-is-More-Risk-Based-Monitoring-of-Site-Performance.pdf. Access-ed 18 January 2016.

Risk Based Monitoring, 2016. Available at http://knowledgent.com/whitepaper/risk-based-monitoring/. Accessed 3 January 2016.

Risk Based Monitoring, 2014. Available at http://www.hccainfo.org/Portals/0/PDFs/Resources/Conference_Handouts/Research_Compliance/2014/302_3slides.pdf. Accessed 3 January 2016.

Alternative models for source data verification, 2014. Available at http://www.slideshare.net/KCRCRO/data-management-alternative. Accessed 10 July 2016.

The Role of the CRO in Effective Risk-Based Monitoring, 2013. Available at http://www.medpace.com/Offers/RBM/Risk-Based-MonitoringMedpace-Whitepaper.pdf. Accessed 15 August 2016.