Regulatory Submission Readiness in the Life Sciences and How Technology Can Help

We have all experienced those late night sessions running around trying to get those last pieces of regulatory content final for our upcoming IND. We tell ourselves, this is the last time I am going to do this, however, ultimately, we know it isn’t. Why do we find ourselves in this situation? Usually due to a lack of regulatory submission planning and complications caused by a large number of individuals involved in producing all of the various pieces of regulatory content. Then we start working towards an NDA this problem is multiplied 100-fold!

Getting submissions in on time is key to speeding up time to market, however, time pressure can also have a negative impact on quality, which ultimately leads to rejected submissions, increased costs and longer timelines. By combining better regulatory submission planning with the use of technology, we can begin to positively impact the results of our regulatory submissions. (Click to Tweet This)

There are multiple factors that contribute to improved submission readiness within the life sciences and it is important to clearly define what these factors are and how you will manage them. Understanding and Identifying where technology can help improve the implementation and control of these factors is also key, and will dictate how you develop your plan. Developing a concrete submission readiness plan which outlines these factors can be a useful tool in ensuring that everyone is on the same page and that you have properly thought out how technology could improve your submission readiness. Below we discuss some of the main factors that improve regulatory submission readiness and how collaborative technology can help:

Template Management

The use of regulatory templates for the creation of submission ready content is extremely important as templates ensure that the correct formatting and layout is being applied right from the get go. One of the issues that we often have is ensuring authors of regulatory content are using the correct template version for the document in hand. Collaborative content management systems (EDMS) like RegDocs Connect and Regulatory Submission Software typically allow you to centrally store, manage and distribute templates which are associated to content or document types. Using a system like this means that authors will automatically gain access to the latest version of the correct template for the type of document they need to author. Additionally the system often can take a copy of the latest template and create a placeholder with it ready for the author to write the document. Effective, automated template management can significantly reduce the amount of rework that the regulatory operations team needs to do and ultimately speed up the final publishing of regulated content.

Training

Training on the production of regulated submission ready content including how to use templates is crucial and a lot of emphasis should be placed on this. Authors of regulated content often do not understand the subtleties of electronic submissions so providing comprehensive training and support is paramount to improving submission readiness. Providing digital content in the form of video guides and in-application help & training will provide easy to access information for authors as they work with content with collaborative systems. This also lessens their dependence on the regulatory team, allowing regulatory to focus on the job at hand – getting the IND in on time…

Submission Planning and Tracking

We have often relied on Excel trackers to plan out the different documents and content that need to be produced for a specific regulatory application. As with all Excel trackers, they can be cumbersome and difficult to maintain, especially with so many people involved with the production of submission content. This is where having a centralized tool to plan all of the content that needs to be produced and assign trackable actions to individuals can have a positive effect on your ability to deliver a quality submission on time. These tools when integrated into the content management system, will allow you to identify the different documents for each sequence, assign due dates and individuals with actionable tasks, create placeholders within the sequences and track progress to final completion of all content. Instead of having to manually update your tracker, the information is compiled in real-time as content is authored, reviewed, published and finalized. You also ultimately spend less time running around trying to track people down to understand the status of documents. 

Automating the Regulatory Submission Process

Content Lifecycle

Defining and managing the lifecycle of documents manually can be a very difficult thing to do. There can be many issues when circulating content for review and managing multiple versions of documents via email or worse still through successive folders on the file-share or even paper. Also ensuring that documents follow the proper workflow through review and approval can be difficult to enforce and track, and in general tends to be very linear rather than parallel in nature. Using a centralized collaborative platform, we can implement workflows which will drive the documents through the various steps required to get a document from draft to submission ready. We are able to track and trend on progress and remind or escalate where necessary. Ultimately the system is focused on keeping the documents moving so that the regulatory team can focus more on the quality of the content itself.

Collaborative Authoring

Many of the documents we produce within a regulatory submission involve multiple parties both internal and external. Without a centralized system we are often left with lengthy sequential authoring processes or many copies of the same content that need to be integrated and that can be contradictory. With the use of collaborative technologies like RegDocs Connect and Microsoft Word, it is possible to perform parallel authoring on documents where all authors work on the same physical document, can see each other’s content, changes and comments in real-time and greatly reduce the amount of work required to integrate all authors work. This is probably one of the single biggest time savers when using collaborative technologies such as SharePoint integrated with Microsoft Word.

eCTD mapping and Integration

Finally, mapping content to the relevant eCTD module and section within the content management system makes it a lot easier to find and integrate content into a backbone. eCTD publishers can navigate through content by module and section and also filter for specific sequences. The ability to map one piece of content to multiple applications is also key. Having this type of feature within the content management system makes it easy to collaborate with both internal and external eCTD publishers, speeding up the backbone generation with the right content first time.

 

Conclusion

Generating regulatory submissions is not simple, and in a manual world can be time consuming and error prone. Using collaborative technologies coupled with good submission readiness planning and training, you can significantly increase the quality while reducing the amount of time required to put submissions together. It’s not just about putting the backbone together and submitting through the gateway, this is the final product, giving yourself the means to properly produce the final product is the key to success and collaborative technology can play a significant role in achieving this.

  

 Automating the Regulatory Submission Process

About the Author: Paul Fenton

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