Assorted Pharma-Sponsored Phase II, III, and IV Clinical Trials Addressing Pain

Client: Several pharmaceutical companies

Client/study focus and needs: We managed phase II, III, and IV pharma sponsored clinical trials with up to 500 participants across up to 20 sites. Studies focused on low back pain, post herpetic neuralgia, diabetic neuropathy, post-operative pain in adults and children, orthopedic pain and post-operative dental pain. For these studies, we designed all study materials (case report forms (CRFs), manuals of operating procedures, checklists), implemented the customized Smart Study™© application for clinical database management, managed clinical sites, monitored safety, and conducted data management, and interim and final statistical analyses.

In addition, our Medical Affairs group provided adverse event and serious adverse event monitoring, coding, and reporting for multiple pharmaceutical companies’ pain studies either as part of clinical study management or as stand-alone safety management.

We created a customized standard operating procedure (SOP) detailing the processes for the receipt, assessment, coding, and follow-up of serious adverse event reports; generated investigator alert letters; wrote the safety section for the annual Investigational New Drug (IND) update reports; and reconciled the safety and clinical databases.

Our customized approach: We maintain a library of U.S. Food and Drug Administration–compliant SOPs, data collection forms, and other study materials that can be used across studies. Customizing these materials instead of creating them de novo is cost effective and time efficient.

Services: Study material development, participant recruitment, staff training, study and data management, safety oversight, onsite monitoring

Results: Use of already developed materials allowed us to begin studies within 6 weeks of final protocol and complete the projects on time and under budget. Further, use of our recruitment plans customized to each site, ongoing training, and careful monitoring of accrual and completion allowed for eligible, compliant study populations.

Drawing on our expertise in this therapeutic area as well as the field of data standardization, we spearheaded efforts to develop and release the pain data standards package for the Clinical Data Interchange Standards Consortium (CDISC).