Scope Definition Important in Launching eSubmissions Program

Carefully defining the scope of an esubmissions program and having cross-functional agreement is "vitally important," Octagon Research Solutions Principal Consultant Gareth Williams told PIR last week.

When you are working to get buy-in for the esubs project, don't neglect senior management, he warned. "Unless you get someone at a senior level prepared to advocate and fund it, your grassroots [esubmissions program] supporters can't get anything going," Williams said.

The good news is that more senior managers, especially those in regulatory affairs, see the value in esubs.

When working on a cross-functional agreement covering what is in scope for the esubmissions project, Williams said it was important to:

Agree which sites are included/excluded and which functions will participate; Define how far back into the document lifecycle you want to go; Define what exactly is meant by "esubmission-ready"' and when documents must be at this status; Specify what file format(s) will be used for reviews; and Determine where people should look for final published submissions.

Esubmissions projects tend to ignite turf battles. One reason, Williams noted, is that esubs impact virtually every company operation and department. "When it comes to esubmissions, such turf wars simply cannot be tolerated if submission deadlines and regulatory requirements are to be met," he noted.

To pre-empt or fix the issue, he advised working aggressively to secure cross-functional buy-in from everyone involved in regulatory submissions. That means you should:

Ensure all functions are represented on the program team and that all regions or countries are also represented; Agree on the definition of an "esubmission-ready" document. "Typically, this means a PDF document where the content, intra-document bookmarks, hyperlinked table of contents, hyperlinked list of tables, figures and cross-references are all complete;" Adopt common processes and standards across functions as far as possible, but allow enough flexibility to meet function-specific business needs; Clearly define the respective roles and responsibilities of contributing functions and regulatory operations in preparing esubmission-ready documents, e.g., who does what, and when; Fund those roles properly with personnel and financial resources; and Develop a sound, consistent and well-documented approach to working with partners.

"One size rarely fits all," Williams noted. Many esubmission programs falter because they become too much about the technology and not enough about the process and goals.

It's a problem he's seen with companies of various sizes, he said. He recalled a big pharma esubmissions project where after a few years of not providing much value, an internal review determined that the project should be taken from IT and transferred to regulatory affairs.

That doesn't mean cutting IT out of the process altogether is a good idea, though. "A partnership with IT is essential," he said. "They have a big stake in it and you need their support."

Esubmission success and improving format quality is not usually achieved through leveraging technology alone, he noted. "Rather, the entire process of developing and submitting documents to an agency needs to be thoroughly mapped out."

For example, with the emergence of esubmissions, enavigation aids such as bookmarks and hyperlinks are mandated by agencies and critical for reviewers such as FDA inspectors. "The best timeframe for applying internal or intra-document enavigation and formatting is in the authoring phase and not during the submission compilation when the documents are often on the critical path," Williams noted. -- Michael Causey