The day starts out slowly. The clinical lead settles into her comfy chair, pushes up her glasses just a bit and gazes at the shimmering computer screen, as the spring breeze sways the branches on the other side of the window. Then, one email (bing)…two emails (bing, bing)… ten, twenty! The beeps roar like a machine gun. Here we go!
We are 2 days away from the submission deadline to the FDA. Operations refuses to approve the document. The dataset includes only 23 patients, while 26 completed the study. Why did no one notice this before? The team’s biostatistician is on a plane. We must find a different way. The administrative assistant procures the correct version of the outputs. Wait! Will the newly-found potential safety issue be the coup de grâce? And, by the way, the safety physician is on vacation in Hong Kong…
At the end of the last day, the cross-functional team members dial in for the final confirmation. It’s over. The document is in. Their eyes are filled with exhausted joy. They feel like superheroes.
We hear such stories all the time, and we celebrate them because the credit is indeed due. The team’s collaboration and dedication are inspiring in the face of potential disaster. However, when we look just a little beyond the fanfare, the great cost of such victories becomes apparent. The budget and the projected time allocation for all functional groups lie in ruins. The impact of the shift in priorities that had to occur to accommodate the chaos is catastrophic. Employees across functional lines get burned out and quit, raising recruiting and training costs. Importantly, the impact of the last-minute data changes remains unknown: Did we actually get the right dataset? Did we miss anything important in a rush? Did we not consider long-term impact? Will this bring refusal to file? With one heroic punch, we have opened Pandora’s Box.
At Synchrogenix, we believe that true document development success is when nothing out of the ordinary happens at all.
Superman vs. Clark Kent
In the last decade, the industry has begun recognizing that regulatory writing experts are uniquely positioned to influence and guide clinical development teams toward successful document submissions.
The superhero battles might get all the glory, but the best regulatory writing experts much prefer the pace of Clark Kent’s office. Unassuming and accommodating, the most effective and efficient writers are thorough thinkers and highly-trained project leaders. They leverage their knowledge and experience in the field to foresee and avoid future stumbling blocks with thorough and timely communication.
In the chaotic world of drug development, a strong regulatory writing team aims to never see the red cape.
At Synchrogenix, we are transforming regulatory writing from a commodity to a strategic asset. We understand our clients’ challenges. This gives us a unique edge: we know what tends to work, and we are excited to share our experience with our clients. To have the best submission experience, we recommend the following tips:
- Establish roles, processes, and expectations up-front: Each team is unique and so is each document. A solid kick-off that includes agreement on the timeline, expectations for each function, alignment on the process, and discussion of the goals for the document and beyond are essential. With all functional area representatives juggling multiple responsibilities, constantly evolving processes, and new technology, a clear and concise set of expectations creates a sense of control and a solid trajectory.
- Create Plan B (and possibly C): Clinical development is fast and dynamic. Consequently, timelines frequently move. Shifting company and functional priorities, critical regulatory agency feedback, and key opinion leader comments can dramatically delay or accelerate document development. Some teams are so used to chaos that they do not take timelines at face value. Discussing the contingencies and dependencies of each milestone allows the team and the writers to prioritize all activities appropriately. Building an alternative timeline at the start of the process creates clarity around impact and obviates the need to scramble for a path forward if the team does need to change strategy. Back-up rescue writing and quality assurance teams can be made ready to quickly assess impact and ensure thorough implementation of new information.
- Look one step beyond the data: Regulatory writing experts have a knack for uncovering tricky and critical unknowns early in the process. For example, the team may know that there were three deaths in the study. After the listings are released, it turns out that there was a fourth death that no one ever mentioned. This death occurred during the follow-up period, so it was excluded from the summary tables. To find this important piece of information early in the process, we might ask the team about the handling of adverse events that occurred during the run-in or follow-up periods.
Your success is our priority
Helping our clients achieve their goals in the most straight-forward and uneventful manner is our job. This means developing robust essential processes, foreseeing the pitfalls, planning for contingencies, and bringing cutting edge technology and the latest regulatory thinking to the table.
Will projects always go perfectly smoothly? Maybe not. However, every time our work does enable our clients to pick up their kids at 5 pm and forget their phones for the rest of the evening, we take a moment to celebrate.
Get a strategic advantage through engaging experts in regulatory writing
To learn more about the Synchrogenix approach, please read this case study. It shows how we helped a client prepare and summarize Common Technical Document (CTD) Modules 1-5 in less than five months. What struggles are you facing in developing a regulatory strategy? Let me know in the comments section!