Posts filed under ‘Organizational Development’

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.


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.


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.

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.


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

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




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.


Credits: Chao Deng and Xiaoqiang Xue

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

2014 in review

The stats helper monkeys prepared a 2014 annual report for this blog.

Here’s an excerpt:

A San Francisco cable car holds 60 people. This blog was viewed about 570 times in 2014. If it were a cable car, it would take about 10 trips to carry that many people.

Click here to see the complete report.

December 31, 2014 at 3:27 AM Leave a comment

Independence | The value


15.Aug.1947 – Tribute

Carrying on with the spirit of thoughts I expressed on 04th of Jul which marked the American Independence day, some compelling lessons stare at us today, as the calendar proudly turned to 15th of August.

For India, the glory of one victory that has held strong for 68 years must now inspire a story of greatness that shall redefine freedom.  A freedom from the ordinary.  A freedom that will liberate us from political stigma and social dogma.

The global canvas is waiting for the tricolor to shine beyond the occasional spark. To become the torch light that grows hope, confidence and fortune. To become more of the land that was, is and will be revered, for time to come.

 This day, when a nation of 1.2 billion stands in attention to praise the sweet victory of “independence”, the same populace has to surpass the challenge of daily…

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August 17, 2014 at 9:40 PM Leave a comment

Thank who you will: Gratitude unlimited


On the heels of a vibrant Diwali in India, followed the effervescence of Thanksgiving in the Americas.  If Diwali is about expressing thanks to everything that brings light to life; Thanksgiving is about saying ‘gracias‘ to everything that ‘Life’ gives us.

A joyous, unbound and omnipresent feel of celebration takes over everything else this week.  The United States had much going on in the past few months from political landslides to weather storms.  However, the spirit as they say, triumphs over all else.  Yes, there was much to moan over, but bundles more to thank for! So arrived… Thanksgiving.

“Culture appreciates life. Thanking rejuvenates ties” – Rajneesh

This day marks the Mayflower voyage of pilgrims in 1621 who were religious separatists seeking to establish a place for practice of free faith. So came to life Plymouth. Having survived adverse conditions at sea, the pilgrims were greeted by Wampanoag…

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November 27, 2013 at 7:16 PM Leave a comment

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