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May 06, 2019
The case for intelligent regulatory submissions: a closer look
By: Margaret Gait

There is little doubt that digital automation processes are becoming standard in industries around the globe. From online insurance applications, and forms for everything from house rentals to doctor’s visits, the push to create automated, traceable, data-driven form submission is increasing in a big way.

Within the life sciences environment, the majority of regulatory bodies that create policy and procedures are increasing their requirements for intelligent submissions––but it isn’t an easy shift. Many people are resistant to change in the regulatory submission process, for reasons ranging from fear and uncertainty to a general aversion toward transformation. But it must be done.

In this post, I want to explore the case for the integration of intelligent regulatory submissions process: what it is, why it matters and how we can break down the barriers to change.

Understanding Intelligent Regulatory Submissions

The format of regulatory submissions has changed substantially over the last 3 decades. Their content can range from less than 10 documents to over 500, and the process starts with a submission creation form. Increasingly, this form not only informs the regulatory operations team that a new submission is needed, but also starts the process of recording the details of the submission in a Regulatory Information Management (RIM) system. This second aspect is usually done manually, and in a case study carried out by an Accenture automation team, the process for recording each submission took a minimum of five minutes. It isn’t uncommon for a team to have over 20 submissions to process in one day, some with as many as 20 sets of records to create or amend. That works out to roughly one to two eight-hour day––with no breaks––just to get through that single batch of submissions.

Intelligent regulatory submissions digitize the process, dramatically reducing the time it takes to get through a batch of submissions. Not only does it speed up the process, but it also improves data quality and frees up the team to concentrate on applying their expertise to the submissions.

Why It Matters

Regulatory authorities are rapidly shifting from being document-driven to data-driven, which is being facilitated by the implementation of intelligent regulatory submissions technology. Through intelligent regulatory submissions, regulators can better analyze the information being provided, increasing accountability throughout the data life-cycle. This deeper understanding provides many opportunities including increased transparency of information, the ability to confirm rather than assume compliance, and to have vast data sets correspond in ways they previously could not.

Additionally, intelligent regulatory submissions allow for cross-referencing of documents, a simplified life cycle, and reduced maintenance efforts––all of which can result in 30 to 50 percent efficiency savings.

Much of this is being supported through Electronic Common Technical Documents, specifically IDMP, XeVDMP, and eCTD V4. These formats are being discussed by authorities around the globe, including several European countries, Canada, Australia, the Gulf Cooperation Council, and more. They provide increased visibility of globally registered information, while allowing for more agility and ability to respond to shifts in the industry. This, combined with data transparency, delivers better understanding to the customer, who is better able to make informed decisions.

Barriers to Adoption

As requirements for intelligent submissions grow and more authorities adopt the move from documents to data, it is incumbent on those doing the submitting to embrace the technology––yet barriers remain. The leading factor in the aversion to change is mistrust of the technology. This mistrust of digital processing exists in almost all industries, including across financial and insurance organizations, and is largely based on not being fully informed on the benefits of the technology.

Where some workers may believe that automation puts their jobs at risk, the reality is just the opposite. Intelligent submissions processes serve as a supplement to help increase efficiency and accuracy, removing many of the tedious or error prone parts of submissions, while still requiring oversight and human touchpoints. This not only allows employees to focus on other key aspects of their roles, but also to serve an important role within transformation overall.

An additional benefit to intelligent regulatory submission technology is work satisfaction and employee retention. Currently, 65 percent of regulatory time resource is spent on submissions. By integrating intelligent processes and reducing that number by 30 to 50 percent, it opens up more opportunity for employees, resulting in a better work environment and increased staff retention.

To be sure, the transition from a primarily manual to a digital process for regulatory submissions is not an easy one. It requires strong leadership and buy-in from all levels, which requires a deeper understanding of the technology itself throughout. If that can happen, the benefits far outweigh the growing pains of change.

To read more about transformation in our industry, I encourage you to visit Accenture’s life sciences blog page.

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