Doing more with less puts automation at the center of the submission process

By Sadia Ahmed and Marcy Miller

The days of throwing money into research without clear objectives and goals for getting to market are gone for most life sciences companies. Today, the pressure is on to cut costs and to find ways to bring drugs to market — and to the patients who need them — faster and with fewer resources.

At the same time, the submission process is more complicated and detailed than ever. Regulators are changing guidances more frequently and demanding more data. As a result, companies are having difficulty managing their workloads with the resources available to them.

Automation is seen as a promising way to address these issues and allow companies to manage their submission processes faster with less likelihood of human error. The emergence of artificial intelligence (AI) means it’s now possible to have a submission tool that knows where to place content based on the workflow and the type of document being produced. And as the AI tool becomes smarter, it also provides analytics around regulatory processes, giving insights into any potential holdups or problems in the chain. This means that regulatory teams will know where improvements in process flow are needed.

The advances in automation are due to exciting technology developments, such as those being made by IBM Watson Health, which make it possible to visualize, share and gain insights from data, as well as to enhance collaboration.

A broad perspective

The other side to improving efficiency means that companies are outsourcing much of the submission process, particularly to partners with low cost centers. However, they need to know that those partners understand the regulations and stay up to date with new guidance and, at the same time, that those partners are innovating in areas such as AI and automation.

And, since the regulatory submission process doesn’t exist in a vacuum, working with a partner that has the technology, know-how and resources across the enterprise is important so the company can be sure that its systems are connected and that data is easily accessible. For example, having quick-alerting features across all systems can alert regulatory personnel to adverse-event issues being reported in clinical trials. Regulatory staff can then take the necessary steps in the submission process and be better prepared to respond to queries from the authorities.

Another prime consideration for life sciences companies is cyber security. If a company’s data is breached, its intellectual property is at risk, which is an ever-increasing hazard in the digital world. Business continuity is an equally important issue and having a partner with an advanced digital platform provides companies with the necessary disaster recovery tools and protections.

Taking a holistic approach to regulatory submissions entails an enterprise-wide approach that enables access to data from multiple different sources and data standardization to use that data more efficiently and with fewer resources. Advanced digital platforms and the capabilities presented by automation can potentially bring organizations closer to achieving greater efficiencies.

Sadia Ahmed has over 18 years of experience in IT and the life sciences Industry working in research and development and global management functions. She has extensive global knowledge of regulations and guidance for electronic submissions. She currently works as product manager for DXC’s Publishing Suite for regulatory publishing.



Marcy Miller is a senior sales executive with extensive experience representing technology and services to the Life Sciences and Healthcare industries. She has 20 years of life sciences experience working as a partner to multiple functions including Research and Development, Business Development, Marketing and Sales, Regulatory Affairs and Operations, Regulatory and Commercial Business Technology and IT.


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