Challenges In Managing Life Science Regulatory Submissions & Correspondence

By Ed Miseta, Chief Editor, Clinical Leader

Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

“Once you’ve made that submission, what will happen next is a lot of back and forth with the regulatory authorities,” says Lori McKellar, Director of Marketing for Life Sciences at EMC-IIG. “There will be questions, requests for clarifications, and requests for additional information, just to name a few. That ongoing conversation will involve emails, phone calls, and meetings (with minutes). Although all of that information is now associated with this particular submission, it is sitting on multiple systems within the organization.”

Lori McKellar, Director of Marketing for Life Sciences, EMC-IIG	Steve Scribner, principal consultant, EMC – Life Sciences

According to McKellar, the emails might be sitting in Outlook or another email system. Individuals will have files stored on their local laptop, and still more information may be stored in shared files. Unfortunately, anyone working on that submission no longer has a consolidated, comprehensive view of the submission along with all of the related correspondence.

“It's not just the creation, review, and approval of documents in that submission, but how you manage all of the additional communication that happens around the submission for the lifetime of the drug,” says McKellar. “What sponsors have had to do is work with a viewer that would allow them to see and view the submissions, but these are typically individual, separate solutions not integrated into the content management system. They're just separate applications. And very few of those can really bring all of this together. Usually personnel are forced to search for information across multiple systems. It’s very time consuming, which can hold up the entire approval process.”

Different Correspondence On Different Systems Is A Challenge

Steve Scribner, principal consultant for EMC – Life Sciences, notes there was a lot of discussion around this topic at the most recent DIA Document Management Conference in Washington D.C. Many attendees voiced the challenge they face working with affiliates and creating a more global perspective when interacting with agencies. “There was one session that addressed this very topic,” he says. “It was interesting to hear their comments. This situation of having different correspondence stored in different places seems to be a struggle even for some of the larger companies.”

The ability to track and monitor those communications is especially important when submitting applications in different parts of the world. According to Scribner, each area/country might require a slightly different application, and similar questions may arise on each one. When answering a question from a certain agency, you must be careful to answer it the same way when it comes up with another agency. “We were looking for a way, call it a 360 degree view if you will, that would allow clients to look at the entire spread of submissions to agencies around the world,” he says. “So far all I have seen to enable this was custom solutions. We felt the market needed a much more cohesive solution.”

McKellar references a paper called Managing Regulatory Information as a Corporate Asset: Industry, Health Authority and Vendor Trends published by Gens and Associates in Fall 2013. Many organizations are working with third-party regulatory affiliates, and 57% of the respondents to the survey said correspondence is managed by a regional or local solution instead of or in addition to a global solution. 

“Just from that viewpoint, you can see why there are so many phone calls being made,” she notes. “Companies just don’t have that full visibility. Another stat that jumped out at me was only 40% of respondents have an authoritative source of information. This is regulated information, and yet only 40% have what they deem to be an authoritative source. On the bright side, 78% of respondents said they had plans to change that situation in the next two years.

Wasted Time Costs Money

The company’s solution, EMC Documentum Submission Store and View, promises to give organizations a complete and readily accessible view of regulatory activity. Although it is too early to provide any metrics on the savings that could accrue from this type of solution, McKellar notes Gens found 40% of the local regulatory affiliates were spending time managing information and taking calls to determine the status of submissions. “If 40% of a person’s time is spent on the phone giving status updates, I think that shows there is a lot of opportunity to improve efficiencies,” she says. “There is also that risk of someone providing a different answer to the same question from different regulatory agencies. There is unknown damage that can occur when the agencies cooperate with each other, correlate their information, and find a sponsor is not being consistent when responding to queries.”

McKellar throws out a final thought: Many organizations have submission documents stored on file shares, and that correspondence may take up several terabytes of data. There continues to be a significant amount of merger and acquisition activity taking place in the life sciences industry. This has led to companies having to deal with legacy issues.

“I believe organizations are looking to consolidate platforms and submission applications, and this is another area where we can provide value,” says McKellar. “We are able to take those legacy submissions sitting on multiple file shares and get them all into one controlled repository, so they can easily find and access any ongoing correspondence. A product might be on the market for 50 years or more. There will be many submissions, activities, and interactions with agencies, and there needs to be a way to consolidate all of that information into a singular view.

“We have come a long way,” adds Scribner. “Not too many years ago we were still handling submissions by sending tons of paperwork to agencies via semi-trailer trucks. Today we have evolved to delivering the documents in electronic format. The next logical step is to allow someone to have a consistent view into submissions that have gone into that agency, including all additional interactions. Although our discussion has been from the viewpoint of a life sciences organization, regulatory agencies also have to keep records and manage the conversations they have with submitters. This is something we can market to them as well, since they face the same challenges as pharma.”