Mission3: Submissions Management at a Glance - New Letter

Introduction

The globalization of clinical trials and introduction of new submission standards and regional requirements such as RPS, eCTD Version 4.0, SPL, CDISC, SDTM, etc. make planning and managing global submissions a huge challenge for Life Science companies. Authors now need to write “electronic documents” using predefined templates that help to link tables and figures and automate bookmarking while following regulations and guidance documents regarding content and format. Publishing no longer happens at the end of the submission process, but continuously throughout. There are many moving parts, components, and required resources that need to be managed; But by whom? Enter Regulatory Operations - the group who does “whatever it takes” to get a submission out on time.

Concept of Submission Management

It is often said that Regulatory Operations only has to “push a button” to create an electronic submission (just don’t say that to any of these mission critical people). While that may have been somewhat true in the past, it is not so today, where the global regulatory landscape has rapidly changed. The future is sure to bring even more changes and challenges.

Expectations of Regulatory Operations have been raised. The function within Regulatory Operations responsible for navigating the complex submission process, defining timelines and managing the publishing process is usually called Submission Management. Submission Managers provide centralized oversight and act as manager, facilitator, and troubleshooter across various functions. They are the “go to” person for submission team members and management because of their in-depth understanding of business requirements and industry standards in relation to supporting technologies and processes.

The Submission Management Process

The submission management process emphasizes upfront and ongoing management, well-defined roles and responsibilities, application of standards and technology, and continuous improvement. Submission Managers requires expertise in project and resource planning, vendor relations/contracts, publishing tools, process management and electronic submission strategy. Additionally, submission managers must be able to communicate and foster collaboration with all levels of the organization, especially management as well as CROs and Medical Writing, Quality and/or Preclinical consultants.

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