PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications such as oncology, CNS/psychiatry, renal disease, respiratory disease/allergy, and several rare diseases. PROMETRIKA’s NDA/MAA Project Managers (PMs) have developed the tools and skills necessary to successfully manage the study level team and the subject matter experts to complete submission projects with high-quality, on-time deliverables.
During planning for the Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and Bioresearch Monitoring Program (BIMO) components, PMs consider five key aspects.
- Best practice recommends submitting the ISS and ISE Statistical Analysis Plans (SAPs) to the regulatory authority at the time of a pre-submission meeting. This provides time for adjustments to the analyses suggested by the authority, which may decrease authority review time once the submission is made.
- Detailed planning prior to the availability of final clinical study data assists in managing stakeholder expectations of the processes and timing of the submission activities.
- The complexity of the submission greatly affects delivery timelines. Complexity is determined by such factors as the number of studies to be integrated; implementation of data-cuts for ongoing studies; managing data from several vendors; SDTM conversion; and up-versioning/down-versioning of adverse event, concomitant medications and procedures, and medical history coding.
- Adequate resources at sponsor and vendor companies are critical due to the simultaneous production and review of multiple documents and analyses. This is especially true at smaller companies where most of the work is conducted and reviewed by only a few individuals.
- A submission timeline differs from a clinical trial in that submission work often occurs simultaneously while for clinical trials, the timeline in the development of trial SAPs, statistical programs, and clinical study reports is mostly sequential. Some submission data preparations and document writing can be simultaneous for the ISS and ISE, and other submission sections. Adding to the layers of activity is the fact that, in most clinical programs today, the final clinical trial is not complete/still ongoing when summarization of data for the submission begins.
As evidenced by the above considerations, NDA/MAA submission work involves careful planning and execution. The possibilities of new treatments and therapies becoming available to patients are the motivation for PMs and study teams during submission development.