Clinical Development Risks and Issues in a COVID-19 World

Posted by Jonathan Rowe on Fri, Mar 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).


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AI & Clinical Trials: Poised for Disruption

Posted by Arun Shastri on Wed, Sep 11, 2019

This blog post is the third in a series on the impact that AI will have on different business aspects of pharma.

We always tell our clients to start small with AI. As Pratap Khedkar shared in my first interview, it’s important to start with clear, specific use cases. For some aspects of the business, it may take some time to carefully consider what these specific use cases are and what opportunities AI can create. Clinical trials present no such difficulties. The opportunities to improve efficiencies are numerous and clear, and AI has begun to make an impact. The industry is aware of the inefficiencies that abound in clinical trial design and execution and is eager to solve them.


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Boost Patient Recruitment With Data-Centric Trial Planning

Posted by Venkat Sethuraman on Fri, Aug 16, 2019

Denise N. Bronner, Gaurav A. Singh and Ray Zhong co-wrote this blog post with Venkat Sethuraman

A common struggle for pharmaceutical companies is poor patient recruitment for clinical trials. As a consequence, 80% of clinical trials fail to meet their enrollment goals, suffer delayed timelines and absorb skyrocketing R&D costs. Ultimately, the patient suffers from delays in the release of needed therapies. Currently, pharmaceutical companies are partnering with trial matching startups to enhance clinical study design, matching and data collection. With analytics and platforms, pharmaceutical companies are beginning to streamline the clinical trial process in hopes of increasing new entrants to the market.


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Advancements in Data Science and Big Data Technologies Will Change the Way Clinical Decisions Are Made Today

Posted by Venkat Sethuraman on Wed, Apr 03, 2019

Venkat Sethuraman co-wrote this post with Jessica Rine, Sharma R D and Francine Leech

The 10th-annual Summit for Clinical Operations Executives (SCOPE) took place Feb. 18-21 in Orlando, and it drew more than 3,000 participants from life sciences companies around the world. The conference covered advanced and innovative solutions in clinical trial planning, management and operations.

While the attendees represented different functional areas within clinical operations, they were united around a common question: How can data be used to bring value, provide actionable insights and enhance the clinical trial process?


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Collaboration in Clinical Operations: Three Takeaways From SCOPE 2018

Posted by Qin Ye on Fri, Mar 02, 2018

Abhay Jha and Venkat Sethuraman co-wrote this blog post with Qin Ye.

More people than ever before attended the ninth-annual Summit for Clinical Ops Executives (SCOPE)—a testament to the growing importance of innovation within clinical development. Attendees from across life sciences gathered in Orlando Feb. 12-15 to discuss clinical development challenges and solutions, and to network with peers and partners.


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