Posts tagged ‘trial of the future’

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


Rajneesh – Web Talk

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