The Future of Regulatory Automation: Automation and Reg Ops in Action - A Syneos Health Case Study

Regulatory operations must evolve to keep pace with advancing technology to advance therapies worldwide in the life sciences industry.

This blog is part of our ongoing series, “The Future of Regulatory Automation in the Biopharma Industry.” Read the full series and explore how our experts can help you streamline your regulatory operations. 

More than ever, now is the time to transform the way regulatory teams operate to bring safe new therapies to market efficiently and effectively. The pharmaceutical industry’s regulatory processes must evolve and utilize advancing technology to satisfy the need for faster, safer and more effective therapies. These technologies can streamline various processes, improve efficiency and accuracy, and provide valuable insight and analysis. 

Given the complexity and volume of automation options for regulatory operations teams to consider, how are experts leveraging technology to improve regulatory operations? Is AI the only approach, or in some cases can low-code / low-cost approaches offer the best solution? Our experts break it down below. 

Case Study: In-House Automation Program Cuts CRF Processing Hours Down By 95% 

Processing regulatory documents, like patient case report forms (CRFs), to submission-ready standards is often performed manually using industry-standard tools. The manual process is time-consuming, highly administrative and at increased risk for human error. A CRF can consist of many thousands of pages and are subject to specific requirements and standards. 

A recent client project presented us with a regulatory document processing challenge: could our experts find a way to cut down on time spent processing the nearly 850 CRFs required for their current submission? In this case specifically, the original estimate was that 150 manual hours were needed to process the nearly one million pages of data within the documents. 

To shorten the manual hours spent on this cumbersome and detailed task, Syneos Health experts developed an out-of-the-box automation tool in a few hours to process the CRFs and bring them to submission-ready standards using existing software. The solution automatically completed laborious tasks such as creating and processing document bookmarks, setting metadata and other document options, removing unwanted standards/items, and naming, optimizing and saving the files. 

What happened next? 

• Automation increased efficiency by nearly 95%: reducing the task from 150 manual hours to 8, freeing publishers to work on other tasks. 
• Delivered to the client ahead of estimate: To be effective, automation tools must streamline operations and bring tasks in on time, especially when working with customers’ regulatory submissions, which are routinely subject to strict agency deadlines. 
• Increased quality while reducing manual quality control (QC) hours: the automation tool processed the CRFs with zero QC issues, meaning significantly lower manual time needed to ensure processing quality. 

Navigating the Future of Regulatory Compliance: Embracing Technology and Collaboration 

The key to a company’s competitiveness and success in the digital age lies in its effective utilization of technology. The cornerstone of any successful technology transformation in a company is the capability to handle the connections between various elements of the technology landscape. Successful transformations rely on mastering complex interdependencies between systems and initiatives and applying the right technology for any given problem or opportunity. 

Regulatory automation is the way forward for organizations looking to stay ahead of the curve in the rapidly evolving regulatory landscape. By not adopting automation, organizations risk falling behind their competitors, failing to meet their regulatory obligations, lower satisfaction levels for key staff, and experiencing higher costs associated with manual processes and non-compliance penalties. 

By embracing automation, organizations can unlock numerous benefits, including increased efficiency, lower compliance costs, better accuracy, and advanced risk management. Automation gives organizations the tools and insights they need to manage their regulatory compliance requirements effectively, stay competitive, and drive business success. 

In this rapidly changing regulatory environment, organizations that embrace automation will be better equipped to meet their regulatory obligations, stay ahead of emerging trends and technologies, and stay competitive in an increasingly complex and dynamic landscape. The time to adopt automation is now, and organizations that do so will be well-positioned to succeed. 

Is your regulatory operations team looking for more insight into automation processes for regulatory processes? Contact the GRAS team to explore new options developed specifically by experts in regulatory operations for the life sciences industry. 

Contributors 

Tapasya Bhardwaj 
Associate Director, Regulatory Affairs | Consulting at Syneos Health

Keira Ledger 
Senior Director of Regulatory Operations| Consulting at Syneos Health 

Mark Bailey 
Associate Director, Regulatory Affairs| Consulting at Syneos Health