Submitting a successful eCTD: 3 keys to effective sponsor-vendor partnerships

Since 2008, FDA has recommended that drug developers submit all electronic submissions via eCTD –electronic common technical document. The eCTD is now the standard format for submitting applications, amendments, supplements and reports to FDA (as well as many ICH regions including Canada, Europe, and Australia), and many drug developers work with a variety of vendors to contribute to their development.

Having supported thousands of eCTD submissions over the past decade, I’ve learned that like any team effort, communication, collaboration and clear rules of engagement are critical to keeping an eCTD on time and on track. Here, I share three keys to creating effective sponsor-vendor partnerships that will help avoid undue stress, while setting your submission up for success.

• Clearly define the scope of work and contract. An eCTD may be a standard global format, but each sponsor has specific preferences and needs. Clarifying those preferences and needs up front, and then fleshing out additional details in the kick off meeting, is a key factor that contributes to the success of the vendor-sponsor relationship.  Key questions to clarify include:
  
  
  • What regions and countries are receiving the submission? The number of applications that need to be submitted can significantly impact timelines.
    
  • Is this the sponsor’s first submission for this specific product? If not, how many previous submissions have been completed?

Remember – a key benefit of the eCTD lies within its ability to communicate and build on the story of a drug’s safety and efficacy.  Each eCTD sequence adds to that story with document-level lifecycle. To effectively tell the next chapter and meet eCTD compliance specifications, new vendors need to have a copy of all past eCTD submissions. The vendor cannot successfully create the next eCTD submission without first loading the past submissions into their system.  That takes time – sometimes a few weeks – to stage, and also requires adequate budget. However, it’s a step that can’t be overlooked, and must be adequately planned for in the timeline.

• Don’t skip the kick-off meeting.  In my experience, the single biggest pitfall to creating a successful eCTD vendor-sponsor relationship occurs when the sponsor chooses to forego a kick off meeting. A kick-off meeting can take time, and money, to plan and implement – but in the long run, it pays for itself when it comes to empowering the team to avoid costly re-work and missed deadlines.  This doesn’t have to be a face-to-face meeting.  A teleconference is almost always sufficient and most cost-effective and efficient for everyone.
  
  Equally as important to having the meeting itself, is to make sure that the right people are at the table. The specific people who will be working day-to-day with the sponsor should be present. If the right people aren’t at the table, the meeting is not likely to be a success in the long-term. Key issues to discuss at the kick-off meeting include:
  
  
  • Are multiple vendors involved, and if so, which vendors are responsible for which facets of the submission?
  • Who are the main point persons at each vendor? Who are their backup or support contacts?
  • How will the various players communicate, and how frequently? Are regular update meetings needed, or not?
  • How will the team handle unplanned, or rush submissions?
  • What are the agreed upon, standard timelines for the different types of routine submissions?

The result of an effective kick-off meeting will yield a detailed contact list, an overview of team roles and responsibilities, agreed-upon timelines and communications processes. The time spent up-front in the kick-off will ideally create a road map that will guide the team’s success through the duration of the relationship.

• Thoroughly define and document the logistics. When it comes to an eCTD, the devil is definitely in the details. In addition to defining the scope of work, the most effective vendor-sponsor partnerships will also clearly document the logistics of how every facet of the submission will be handled. Key logistics to confirm include:
  
  
  • Is the sponsor authoring their own document or will the vendor?
  • Does the sponsor want the vendor to perform final formatting on each document? What format will be used? Microsoft Word or PDF?
  • Does the sponsor need the vendor to provide eCTD templates?
  • Will the sponsor use electronic signature for cover letters and forms? Or will they provide a signed, scanned copy?
  • How will documents be shared between the sponsor and the vendor for publishing and final submission review?? Does the sponsor have its own SharePoint or other electronic document management system, or will it need to use a system provided by the vendor? Regardless of the answer, ample time needs to be built into the timeline, so all parties can access the system, and so the system can be built out to accommodate the necessary content.
  • Will the vendor submit to the regional Health Authority on behalf of the sponsor?

Even very specific issues – like how the sponsor will indicate where they want the vendor to build hyperlinks within documents – need to be clarified up front.

To avoid costly rework and delays, the most effective vendor-sponsor relationships will be true partnerships, where each player fully understands its role, responsibilities and requirements – from the start. Taking the time up front to create a clear road map for how all details will be managed, and for how all players will work together, is the best bet to avoid undue stress, and ensure eCTD submission success.