Managing eCTD submission projects involves balancing a complex set of conflicting requirements. The role of Submission Project Manager is often vaguely defined and ends up defaulting to someone in Regulatory Operations, who may be more skilled as a publisher than project manager. While every project is different, there are key elements that will be part of every submission project. The right approach can minimize stress by outlining the process and identifying the key handoff points between functions.
What Do You Really Need to Manage?
The best place to start is by determining what you need to manage. There is no one-size-fits-all answer to this question, since every company has a different set of systems, people, and issues, but there are a few things that I think apply to all submissions:
- Regulatory Operations needs a way to track every document that will go into the submission and when they expect to receive them. Depending on the RegOps process, they may need to track documents as they move through formatting, rendition, publishing, and QC steps. This kind of plan can help determine resource needs during the final publishing effort.
- Functional areas need to track their internal workload and deliverables schedule to ensure that they can meet submission timelines without overly stressing their organization.
- Program Managers and Senior Management need to have visibility into submission projects to ensure that resources are allocated appropriately and corporate timelines will be met. This may mean that risk factors need to be identified and tracked along with timelines to give early indications of potential problems.
- For companies working on several simultaneous submissions, it's helpful to develop a submission schedule to manage resources across projects. The key here is to capture information about upcoming submissions early in the process to identify potential conflicts. Most submissions seem to get scheduled on the 15th and 30th of the month. Spreading things out a little makes the publishing process much more manageable.
Each of these needs is real and must be addressed by whatever solution is adopted. In an ideal world, an integrated approach to submission management would allow functions to manage their own work while seamlessly reporting status information to management and downstream groups like RegOps. Unless your company has such a solution, you can manage with a set of simple tools and good communication.
Different Tools for Different Jobs
The goal in managing a submission project is to ensure that everyone crosses the finish line together, without burning out the resources in any given area. To meet that goal, you need to ensure that your plan helps you identify risks early and highlights areas that would benefit from additional resources. For most marketing applications, documents trickle in over several months, and then a tsunami arrives in the final weeks. If you made a graph of documents received by RegOps over time, the curve would look like a hockey stick. By the time you reach the vertical portion of the graph it's too late to adjust timelines and resources. An added wrinkle to most submissions is that teams are distributed geographically, and often include CROs, consultants, development partners, and CMOs. A successful project plan has to address these realities.
Here are some approaches that I think make sense:
- For Regulatory Operations, a spreadsheet that lists every document in the submission is a great way to track what's due when. Add columns for due date, author, date received, and any RegOps process steps you want to track. Think of this as your inventory tracking system. I created an example you can modify for your own use, here. It lists all the sections of a US eCTD and the basic RegOps process steps.
- Functional areas may want to use a Gantt chart to track authoring and review cycles. Don't forget to include any outside groups, such as QA, partners, and CMOs that need to review final content. Make sure to include a milestone for the handoff to RegOps.
- For management and development partners, a high-level timeline that tracks sections of the submission and identifies risks to the timeline may be more appropriate. If you already have a corporate dashboard, you may be able to feed into that. Otherwise, determine the key indicators that will demonstrate the project is in control and will be delivered on time.
It's critical to develop a process for integrating the information from each system to the others. Each system should be the official keeper of one or more types of information. For example, RegOps tracks which documents are complete, while the functions track their own review processes. In order for the submission to be successful the parts must come together, so communicating status and risk without drama is an important skill to embed in your team culture.
There is a new breed of web-based project management tools available that are worth investigating. These tools were designed to help manage geographically dispersed teams and projects, and are generally less complex and more user-friendly than MS Project. These tools were built from the ground up with collaboration in mind. The simplest approach to collaboration allows people to comment on tasks. More sophisticated tools enable you to associate tasks with risk factors and model potential outcomes. There are dozens of these tools available and many provide free trials. Most are priced at about $20/user/month, so you can get started without too much overhead.
Submission project management is not a static discipline. A submission project may require a variety to tools to meet the needs of different parts of the organization. The main thing is to recognize the way your organization works and the way information moves through the organization, then find a set of tools that works for you.
- Blog post on eCTD project management