Case Study: Major Pain Orthopedic Intervention

Musculoskeletal symptoms are some of the most common reasons for physician visits. These symptoms may include pain, aches, soreness, discomfort, cramps, spasms, tumors, stiffness, weakness, swelling, and limitation of movement to the musculoskeletal system.

The goal of this phase clinical III study is to evaluate the efficacy of the study drug in two different forms, one being administered intravenously and the other orally on postoperative pain in patients undergoing major orthopedic elective surgery of low extremities like hip or knee replacement. This is a randomized study which is double blind, and placebo controlled as well. This study requires 70 patients ranging between the ages of 18-70 who have recently undergone orthopedic surgery like hip or knee replacement will be recruited into the study.

This study initially started with 4 sites and the recruitment of only 30 patients in 12 months for the study, which was far from the requirements set by the Sponsor. The initial CRO responsible for the recruitment of patients failed in their duty of sufficiently supplying the study with an adequate amount of patients.

This is where OCT was called upon to rescue the study. OCT has had a sufficient amount of experience in the rescue study department, which enables us to overcome different obstacles. OCT managed to salvage the same sites that the initial CRO used, but because of OCT excellent relationship with the site investigator’s we were able to get much more out of the same sites. By not having to open new sites OCT was able to save the Sponsor precious time in the study and a substantial amount of money. Within 16 months OCT has recruited 71 patients more than double the initial CRO and within almost the same timeframe.

OCT is a full service CRO company with multiple offices throughout Russia, CIS, and CEE. We are an ever expanding organization with no project being too small or large. Where this initial CRO failed in this study by not being able to recruit the adequate amount of patients, OCT quickly and diligently stepped in to rescue them. OCT success is based on calculated procedures, which hopefully keep satisfying the Sponsor like they did this time.