Comprehensive experience in New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) is rare, even among researchers who have successfully advanced development programs to late-stage clinical trials. The PROMETRIKA team includes several statisticians, medical writers and other clinical research professionals who have successfully developed dossiers for FDA and EMA regulatory submissions. The combined experience at PROMETRIKA includes 12 NDAs/MAAs. Our contributions include highly-specialized statistical analyses of integrated safety data, meta-analyses of efficacy data, and expert medical writing to support optimal strategies in positioning and presenting clinical research results in submission materials. We often participate in FDA meetings and teleconferences with, and on behalf of, our clients.
The PROMETRIKA team has developed NDAs and MAAs in a variety of therapeutic areas.
- ISS, ISE, and Summary of Clinical Pharmacology for the treatment of acute myelogenous leukemia; presentation to Oncologic Drugs Advisory Committee (ODAC).
- ISS for the treatment of Fabry disease, developed and submitted successfully to the EMA, and modified significantly, with major augmentation of data and analyses, several years later for submission to the FDA
- ISS (including SAP), ISE (including SAP), and Clinical Summaries, for the treatment of neuroendocrine tumors; CDISC conversion for SDTM & ADaM datasets
- Biostatistics and statistical programming for two ISS’ (two compounds) and an ISE for multiple sclerosis
- ISS and ISE (including biostatistics and statistical programming) for post-operative pain management, post-partum depression, and Hodgkin’s lymphoma; support for FDA interactions; remedial clinical operations, data management, and biostatistics services for several phase 3 trials in the program; validation of all third party analyses
- ISS (including SAP) and Clinical Summaries for non-dialysis dependent chronic kidney disease; CDISC conversion for SDTM & ADaM datasets
- ISS, ISE, Summary of Risk and Benefit, Summary of Statistical Methodology, and other summary sections for an oral asthma medication
- ISS, ISE, Summary of Statistical Methodology, and CSRs for 13 clinical studies for a nasal steroid used to treat allergic rhinitis
- ISS, ISE, Application Summary, pre-clinical sections, and CSRs for 19 studies for an ocular antihistamine to treat allergic conjunctivitis
- European submission for a steroid metered-dose powder inhaler (MDPI)