There are three primary trends that are impacting clinical development. These trends are causing Life Science organizations to re-assess their current operations to find areas of improvement that can be made with respect to people, processes, and technology.

1 – Changing Nature of Work

One significant change we are noticing is in the work environment. COVID has certainly expedited some of that shift. There are new trial paradigms that need to be addressed. There is an emerging requirement for decentralized trials, telemedicine, and other areas that are extremely critical as we consider how we approach clinical trials.

That includes allowing direct patient access to both the trials and information. Additionally, stemming from this patient access is the need to use real-world data and simulations in the analysis and ensuring that the data is presented in contextual user-friendly ways that can be understood by both patients as well as scientists and clinicians.

2 – Increased Complexity

We are also witnessing increased complexity in the clinical development environment. The ecosystem has been in place for a while and we’ve seeing a lot of silos of information. Additionally, there is an increase in the volume and the diversity of the data we’re collecting that needs to be addressed. This is creating some gaps. We also have more and more vendors and partners who are working together on clinical programs and data is not consistent in the way it comes in since not everyone is following the same data standards.

Additionally, it is complicated to share and reuse clinical data because data standards are not aligned. However, we need standardized data to run trial analytics and also to look cross functionally and be able to drive and inform clinical programs, trial design, etc. This lack of consistency and uniform data platforms leads to an onerous ability to access and use our data in innovative ways.

3 – Emerging Technology Capabilities

We’re also seeing major changes happening with technology as it relates to clinical development. For example, digital patient engagement and the use of wearable sensors along with other technologies and devices are becoming more prevalent and making an impact. Also, the increased capacity and capabilities of automation, artificial intelligence, and machine learning, as well as the ability to use knowledge graphs and semantic layers, natural language processing, and natural language generation are all emerging capabilities that we want to be able to take advantage of within the development area.

Additionally, vendors are changing as well, although some are still on older technologies. Most are moving to a newer technology infrastructure and this requires clinical development departments to be positioned to incorporate that scenario as well as ensuring cyber security, privacy, and how blockchain applies as well.

Summary

Todays clinical development environment has complex, very siloed, and usually aging technology in use. Moving into the future there is a need to transform this area of the business to a nimble integrated data and platform centric environment. This reduces the technical debt. This also creates a capability to have shared platforms that are used across the organization. Additionally, we want to apply fair data principles as well.

Why It Matters to You

In order to improve the clinical development area of the organization there is a need to first understand the current situation and the trends that can impact operations. In this blog, we discussed:

• Three key clinical development trends that are impacting Life Science organizations’ operations.
• Why these trends need to be addressed.
• What to do to transform the clinical development area to take advantage of these trends.

To learn how we get there by leveraging emerging technologies and smart architecture design watch our webinar that shares this in detail.

ResultWorks is an Astrix Business

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations. ResultWorks, an Astrix business, achieves success for our clients through skilled facilitation and exceptional management leadership across Life Science domains from Research, Non-Clinical & Clinical Development, Regulatory Affairs, to Safety, Manufacturing, and Pharmacovigilance. To learn more about how ResultWorks enables biopharmaceutical leaders’ success, visit www.resultworksllc.com.

To learn the latest about how Astrix is transforming the way science-based business succeed today, visit www.astrixinc.com