Thought paper: Clinical Trial of the Future

Technology and the breadth and depth of curated healthcare data sources continues to grow. Advanced analytics, artificial intelligence, and predictive analytics provide faster, more precise decision-making – yet adoption of these advancements continues to lag. As clinical development evolves to a new age of trial conduct models, there is an increasing awareness of the need for practices that enable closer engagement with patients and for increased adoption of the rapidly changing technology landscape.

Detailed discourse through white paper:

We have presented a series of thoughts in the form of an idea thread and would love to hear your views and opinions.

Insight brief

Link to full white paper

Full read: Clinical Trial and CRA of the future

This paper will discuss specifically the component of clinical monitoring and the transforming role of Clinical Research Associates (CRA/site monitor) as part of the future of clinical trials. The scope of this discussion includes aspects of innovative and emerging clinical trial models, the changing technology landscape, digitization and virtualization of trials including, but not limited to, site monitoring activities and in summary, the impact to CRA as a role, their required skill-sets and changing responsibilities.

Where to next:
Complex protocols, lack of resources, increasing adoption of new data collection technologies, and the advancement of digital trial strategies are creating a real opportunity to address the industry challenges around site monitoring and clinical workforce management. By right fitting the strategy of digitization and virtualization of trial process, the CRAs could drive higher quality and efficiency in site monitoring process.

This is by way of improving practices that impact patient safety and data quality as they can focus on areas that need their true and prioritized attention.

Conclusion: 

Sites have come to rely on CRAs far too heavily for a lot of quality verification when in fact the CRAs could be leveraged more meaningfully to improve the site and patient experience on a clinical trial. Remote and centralized management of several onsite activities provides CRAs the opportunity towards setting up an effective site relationship management, focused site quality management and patient engagement.

The clinical trial of future would require for process models to adopt new technology architecture and build monitoring strategies that will evolve the role of CRA for better.

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https://www.iqvia.com/en/library/white-papers/the-clinical-trial-and-cra-of-the-future

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May 21, 2018 at 12:06 PM Leave a comment

Role of Innovation and New Age Analytics in RBM Evolution

Hope you’ve had a great start to 2018 and best wishes for all innovative projects out there to solve the myriad of issues across the globe.

One tiny area we are looking to make a difference is in healthcare and clinical trial execution. Part of that effort includes engagement at industry events, one of which is detailed below. Would love to converse with you or hear your thoughts. Please share.

Track: Implementing Risk-Based Monitoring: SCOPE, February 13-14, 2018

Been an engaging experience at SCOPE these past few years. Looking forward to the 2018 exchange.

https://lnkd.in/e8vD95n

Few areas we will focus on during our luncheon presentation:

  1. What problems are we looking to solve with innovation in RBM models?
  2. How do the new age analytics and advent of machine learning augment risk-based strategies?
  3. What results are we experiencing through implementation of statistical monitoring and analytics?

Welcome thoughts, ideas and conversations via this post or at Orlando, Florida.

Cheers.

February 4, 2018 at 2:38 PM Leave a comment

Let’s talk Analytics – Miami Jan.24-25

Impact to Quality from implementation of Risk Based Monitoring and Analytics

– Optimize site monitoring process flow and risk management
– Processes that impact data flow and data quality positively
– Improving oversight and control through advanced analytics and actionable insights

Continue Reading January 17, 2017 at 9:46 AM Leave a comment

Global Webinar – Centralized Monitoring

Presenting a webinar to discuss the most current developments in the world of centralized monitoring. Includes topics of technology workflow and advanced analytics.

The Next Wave of Centralized Monitoring Webinar

November 11, 2016 – 11:00AM EST Registration Link: http://bit.ly/2f3mptJ

Description: Attend this live webinar as RBM market leader QuintilesIMS shares why centralized monitoring is critical to RBM success. Attendees will hear about the latest technology enhancements advancing centralized monitoring effectiveness and novel Predictive Analytics capabilities providing new levels of study, site and subject insights.

October 31, 2016 at 4:31 AM Leave a comment

Application of Model-Based Analytics in Risk-Based Monitoring

Speaking on

“Model-Based Analytics in Risk-Based Monitoring”

Jul 31, 11:30 – 13:00 CST

Healthcare 2015, Nashville TN

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Abstract:

This project addresses: how can we identify clinical trial quality issues upfront, and how can we improve investigative site performance? We developed an interactive integrated analytics tool that transforms sophisticated statistical analysis into insightful information and actionable decisions. For a given risk level, the analysis identifies those investigative sites and their associated data points that exhibit higher risk potentials compared to their peers. This practice can enable the study team to target and prioritize resources around identifiable risks relating to subject safety and investigative site performance.

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Credits: Chao Deng and Xiaoqiang Xue

http://meetings2.informs.org/wordpress/healthcare2015/

July 13, 2015 at 5:05 PM Leave a comment

Results from implementing Risk Based Monitoring

4th Annual Clinical Data Integration and Management 2015 

3:00 PM EST, Princeton New Jersey.


Presenting Case Study: Delivering Results with Risk-based Monitoring approaches

The market is adopting RBM to transform clinical development. Technology is powering this with new roles and processes, enabling faster, more informed decisions. In this session you’ll:

–          The role technology plays in integrating patient, site, study and program data

–          How new processes with new roles is delivering faster ‘analysis ready’ data

–          See how holistic data is improving data quality and is impacting safety

–          Understand how holistic & predictive analytics can enhance patient safety

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Rajneesh Patil – Speaker

Director, Integrated Process and Technology, QUINTILES

March 25, 2015 at 8:46 PM Leave a comment

Data 4 Decisions, Raleigh – Speaking on Analytics and RBM

The Data Difference: Risk Based Monitoring and Patient Safety | Tuesday, March 24 from 3:25 to 4:25.

Shall be speaking about the role of data and predictive analytics in Risk Based Monitoring and Subject safety. Glad to be joined by my Quintiles colleague Boyce Byerly.  

d4d

Session objectives are set to provide attendees with insights into:

  • The overarching “data” strategy to lay the foundation for Risk Based Monitoring of clinical trials.
  • How ‘data-driven’ decisions enable the implementation of Risk Based Monitoring principles.
  • The significance of near real-time trigger management systems to effectively monitor clinical trial sites.
  • The role of centralized monitoring and data analytics in ensuring subject safety through data reviews.
  • The potential opportunity to explore advanced and predictive analytics in the space of clinical trial conduct.
  • Opportunities in analyzing and visualizing data to draw meaning from the many inputs.

More at: Conference web link

March 1, 2015 at 6:53 PM Leave a comment

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