Analgesic in patients with dysmenorrhea, phase III
Background: Smooth Drug Development was hired by a global company to set up a clinical trial to add a new indications for the use of analgesic in dysmenorrhea.
About a trial: In this study, our services were data management, sites monitoring, ePRO, biostatistics, and preparation of the final report. We oversaw the logistics of the study, including purchasing of the reference medication and rescue therapy. Additionally, our team wrote modules 2.4-2.7 of the registration dossier and prepared and submitted a periodic safety report (PSUR).
Challenges: At the beginning of the project the customer experienced delays with the drug, so the launch of the trial was repeatedly postponed. After importing the drug, we immediately started the clinical part, since all the preparatory work was done. From that point on, there were no difficulties in the project, but due to the postponement of the start of the project, the patient enrollment period had to be cut in half. The study recruited 160 subjects at 7 sites in 3 months.