(2 of 4) Transitioning from Clinical Research to FDA Review: Clinical Data Application Assembly Team

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Are you planning, or currently in, the process of building your submission clinical data package for a New Drug Application (NDA) or Biologics License Application (BLA)? It can be a complicated process, and in this blog series, we are discussing some of the most important considerations to keep in mind while preparing for FDA submission of clinical data and analytics. Our last post covered the process of preparing the application deliverables to showcase all of the safety and efficacy evidence on your new biologic or pharmaceutical. This time, we are looking specifically at the team members you will need to assemble to ensure the process is smooth and flawless.

When it comes time to prepare for your NDA or BLA submission, there are certain key team players that are needed to successfully guide your product through the application process. Before diving too deep into its necessary components, here are the key priorities to consider when designing this assembly team:

  1. Regulatory initial acceptance of the submission package
  2. Swift submission following the completion of all phase 3 trials
  3. Ensuring this process follows strict procedures to avoid issues with regulatory auditing
  4. Anticipating regulatory agency inquiries to reduce overall review time

Achieving these goals requires professionals with knowledge and expertise in statistics, analytics programming, CDISC data standards, and the regulatory submission process. Here are some of the key positions and teams needed:

Overall Project Manager

This person is your lead submission statistician and is responsible for creating and maintaining the application timeline. They will also be tasked with developing the statistical analysis strategies to be used for your clinical trials, as well as reviewing the quality control of these methods. Generally, this position is held by someone within the sponsor company who leads the analytical team.

Submission Data Planning & Review Team

The Planning and Review team is composed of at least one SDTM expert, one ADaM expert, and lead statisticians and programmers of the clinical trials. They will create the data standardization plan and review the M5 data packages produced by each study group. This team can consist of employees of the sponsor organization, or employees of the CRO. Since properly structuring your study data is an important aspect of the submission process, including experts with prior regulatory approval experience is highly beneficial.

ISS/ISE Analysis Team

In a sponsor/CRO collaboration model, both the sponsor organization and CRO will have an ISS/ISE team. First, the CRO group will create the analysis and data packages as per the statistical analysis plan. Then, the sponsor’s team, consisting of their internal biostatistician and programming team, will review and validate the analysis and data package created. Additionally, the CRO’s team can help to create the pivotal studies necessary for auditing the BIMO data package. These two factions will work collaboratively throughout the application process to be sure all bases are covered.

Phase 3 Analysis Team

The Phase 3 Analysis team should be structured similarly to the ISS/ISE study team, as the two will work in parallel to finish the submission package as quickly as possible before FDA submission. After submission and during the regulatory review period, the ISS/ISE team can focus on the 120-day update package, while the phase 3 team focuses on responding to any and all FDA inquiries.

Stay tuned for the rest of this blog series as we continue to explore some of the significant components of transitioning from the research phase to regulatory review and approval. As always, if you have any questions about clinical trial biostatistics, feel free to contact Princeton Pharmatech to schedule your consultation.

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