Who would have thought when we completed work on the first submission for which we ever authored 3 or more documents and provided strategic support (our criteria for saying that we supported a client’s submission), that we’d be celebrating our 300th such submission just 12 years later. From that humble beginning, we’ve now supported more than 50 submissions per year for the past 3 years.
As you might imagine, we’ve seen and learned a few things along the way, so we’d like to share some of our top lessons learned. Aside from learning that there are lots of ways of generating submissions, there are some common themes. Here are our top Lessons Learned from our first 300 submissions:
- Communicate. There’s no such thing as overcommunication on a submission as every “lessons learned” ever conducted points out. Be more inclusive, both in meeting attendance, recording minutes and decisions, and sharing those broadly.
- Account for EVERYTHING. Submission plans fall apart if a component (eg, CDISC or SEND datasets, stability, and validation reports) was forgotten until late in the process.
- Seek health authority input as early as possible. The number one cause of delays is unexpected regulatory feedback and requests, especially over the past 2 years. The earlier you can get this input the better. Also, create a timeline scenario based on receipt of unexpected requests.
- Remain flexible. No submission ever goes exactly as planned. Think and plan in terms of scenarios, and know where you have flexibility (eg, shortening review periods from 5 business days to 3 business days, reviewing partial drafts to reduce what remains to be done after the now-delayed final data or report become available).
- Include upper management (approvers) as early as possible. Nothing derails a submission and deflates a team more than senior management coming in at the last minute and proposing major changes – even if they are very good changes (which we’ve seen many times).
- Know the history of the project. Review the minutes from all prior health authority interactions to know what was agreed and then confirm if and how the company has addressed those agreements. These agreements need to be clearly accounted for in the submission summaries.
- Don’t build a plan that requires a high-stress crunch at the end. While every submission has a stressful crunch-time near the end, do NOT create a plan that creates that crunch. Do everything you can to create plans that don’t include weekend and holiday work or require in-person lockdowns to get to the desired submission target.
As we move beyond our 300th supported submission, we’re helping our clients address new trends such as parallel authoring of reports and summaries, demands for ever-faster completion, and expanding use of AI and other tech-enabled tools. We’d love to help you address all of these on your next submission.
