Observational program in hemorrhoids

Background: Smooth Drug Development was selected by a global pharmaceutical company to organize an observational program to evaluate changes in symptoms severity during the course of treatment.

About a trial: As part of the program, we were involved in the adaptation of the documentation package, data management, biostatistics, and monitoring of sites. The program enrolled 1,000 subjects with 14 centers in less than a year.

Challenges: During the planning stage of the non-interventional study, sites were selected by the client's marketing department. Smooth Drug Development did not participate in the selection of the sites at the initial stage. In the middle of the study we understood that we are late on patient enrolment deadlines. After discussion with the sponsor, we proposed to include additional sites selected by Smooth Drug Development. We selected and included 5 additional centers in the study, which helped close enrollment ahead of schedule.