Our History
PROMETRIKA, LLC was incorporated in January 2003 and started operations in April 2003 in Cambridge, Massachusetts offering complete biostatistical, data management, and medical writing services.
PROMETRIKA was formed by key members of the drug development division at a mid-sized international pharmaceutical company that had ceased its US research operations in early 2003. The company founders, a cohesive and synergistic group with a 10-year history of collaboration in the drug development arena, by then had a proven record of success, including two new drug application (NDA) approvals by the FDA and one successful European submission.
As part of the drug development division of a pharmaceutical company, members of the PROMETRIKA core team were responsible for the study design, protocol development, data management, statistical analyses, and medical writing of approximately 100 Phase 1 to Phase 4 clinical trials. These trials ranged from small pharmacokinetic crossover studies to large and long-term international trials, including several hundred patients.
The PROMETRIKA core team was also responsible for the development and compilation of NDAs, including Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and other summary sections as well as interacting with the medical and statistical reviewers at the FDA. Two NDAs, one for a nasal steroid and one for an ocular antihistamine were approved by the FDA in the year 2000. One European submission for a steroid metered-dose powder inhaler (MDPI) was approved by the German regulatory body.