How We Moved to Agile for Regulatory Submissions and Why It Works

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The following post is the first of six in GlobalSubmit’s Agile for Regulatory Submissions series. GlobalSubmit’s regulatory services team employs the Agile methodology for regulatory publishing projects. By instituting Agile principles, our team has been very successful in delivering high-quality submissions ahead of schedule while maintaining constant, clear lines of communication with clients. To date, 75% of the regulatory submission projects executed by GlobalSubmit have been completed ahead of schedule.

The content you’ll read in our Agile for Regulatory Submissions series is adapted from the original work of Ken Schwaber and Jeff Sutherland called the Scrum Guide under the Attribution Share-Alike license of Creative Commons. Our series, which differs from the original work in the industry it describes, end product of the Agile process and professionals involved in producing the end product, is available for license under the identical terms.

I have been in the business of software development for 20 years, first building products to analyze financial data and more recently developing the system the US FDA has used to review electronic submissions for the past decade and counting. I was also a leader in the effort to raise global electronic submission standards and worked to hasten our industry’s adoption of cloud-based technology solutions.

Publication of the Agile Manifesto, written in 2001, turned out to be a seminal moment for the software development community. That decree, co-signed by a group of 17 experts in the field, is a wellspring of scholarly publications, best practices and well-attended conferences, all advancing Agile as the most sensible methodology for large—almost impossible to plan—projects, where change is unavoidable and transparency is paramount for success.

The Agile methodology is now wildly popular and its reach extends beyond software development. My career at GlobalSubmit coincided with the rise of Agile and I’ve been a keen observer and practitioner of its principles.

GlobalSubmit applied Agile Principles to software development five years ago and realized a great number of measured efficiencies and quality improvements. As an organization collaborating with the heavily regulated life sciences industry, we contributed ways to validate systems developed using Agile processes to the existing body of knowledge.

Originally written as principles for software development, Agile was later applied to project management. Regulatory publishing projects, being as complex as they are, were obvious candidates for the application of Agile Principles.

As GlobalSubmit’s regulatory services team matured and took on larger, more complicated projects, it became apparent that the factors famous for hindering development efforts were also causing delays and issues in regulatory publishing. There was a lack of transparency as to the work being done, both internally and for the client, and we didn’t have a process in place that allowed for frequent self-correction.

The decision was made to apply Agile Principles to regulatory publishing.

Change is never easy, but looking back at what we had accomplished during the first 12 months guided by Agile Principles, the data pulled from our Submission Tracker substantiated our belief that use of this methodology would yield positive results.

After moving from the more common “waterfall” project management style to Agile for regulatory submissions, our team has submitted 75% of projects early—a rate unheard of in our industry. We have not had to work late into the evening or spend weekends in the office during the final push to meet deadlines. There have been exceptions. Our team was brought in to rescue projects with timelines compressed in half, but even then, there was no need for anyone to extend themselves to 50 hours a week.

Working long hours in the “last mile” is customary. Contingencies are made. We recently filed an NDA submission a week ahead of schedule. The client booked a block of hotel rooms across from their office for the final month of the project—the rooms were never used and late hours weren’t required.

An IND with a 4-week burn down from first document delivered to submission was another recent filing that went in ahead of schedule – this time 4 days.

When dealing with large or small regulatory submissions, instituting Agile Principles is a break from the status quo. The Agile guiding principles listed below have helped our team deliver high-quality submissions and beat our client’s expectations:

  • Visibility makes the constant delivery of submission-ready documents possible and allows us to quickly correct of any problems; other workflows push corrections to the tail end of a project
  • Client has full knowledge of submission status and ability to review documents in real time
  • Sections closed out and approved early to remove stress from final stress run

The act of compiling a regulatory submission is highly stressful, with the health of underserved patient populations and the financial viability of the client often at stake, and characterized by high turnover rates. High turnover is partly due to the marathon nature of a submission project and the unforgiving sprint to the finish line.

Submissions don’t have to be managed in such a frenzied way. By sharing our innovative approach, GlobalSubmit hopes to transform the status quo for regulatory publishing. Agile Principles combined with our leading technology solutions insulates a client from the usual deadline pressures and brings down costs when all assumptions are considered – all while submitting on time or early.

At the end of the series, you’ll have an understanding of how the Agile for Regulatory Submissions framework makes it possible to manage submissions in a different, more sensible way.

©2015 GlobalSubmit. Offered for license under the Attribution Share-Alike license of Creative Commons, accessible at http://creativecommons.org/licenses/by-sa/4.0/legalcode and also described in summary form at http://creativecommons.org/licenses/by-sa/4.0/. By utilizing this Agile for Regulatory Submissions content, you acknowledge and agree that you have read and agree to be bound by the terms of the Attribution Share-Alike license of Creative

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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