Pain Clinical Trials
inVentiv Health Clinical’s team of pain management specialists have conducted a wide variety of analgesic-related clinical studies for back pain, cancer pain, dermal and laser procedures, headache, migraine, neuropathy, osteoarthritis, and post-surgical pain. With a comprehensive range of services and deep experience, we can define a clear development plan for your drug, device, or combination product and manage the trial from start to finish.
We have successfully conducted more than 80 pain studies involving more than 4,000 clinical sites and 40,000 patients in the past five years in both adult and pediatric pain indications. One large program involved 15 studies and 18,000 patients with chronic low back pain and osteoarthritis at approximately 1600 sites. Our expert staff executes development programs in the Americas, Europe, and Asia-Pacific regions, utilizing the applied knowledge and intelligent solutions you expect from a global drug development leader.
inVentiv Health Clinical has rapid access to investigators across a variety of pain indications and maintains strong relationships with neurologists, pain management specialists, surgeons, anesthetists, general practice investigators, and professional research site experts. We understand that well-established relationships with experienced, qualified and motivated sites are crucial. After selection, a continuous dialogue with study centers ensures efficiency, effective recruitment, and continued retention of study subjects.
Your program will be monitored by experienced clinical research associates, project managers, and medical monitors. Our staff has extensive knowledge in working with the various instruments and questionnaires (e.g., BPI, MPI, MSQ, MSQoL, NIS, NRS, VRS, VAS, WOMAC, etc.) devised to capture responses to therapy. Our monitors also assist study coordinators in training patients to complete self-rated pain scales, reinforcing timely capture and review of responses in patient diary data serving as primary endpoints. They are entrenched in extensive education, review, and feedback with site personnel to ensure quality and consistency across all study sites. Study-specific risks in pain studies and program contingencies are identified so rapid recovery plans are in place.
inVentiv Health Clinical's surgical pain teams understand the importance of control over analgesia protocols in surgical and post-operative care settings to assure success in acute post-operative pain models. With established procedures to manage opiate drugs in clinical trials, inVentiv Health Clinical can maintain the control of the supply chain for global distribution. We also provide training to sites in the proper handling of Schedule II drugs to comply with regulatory requirements and prevent diversion.
More importantly, the inVentiv Health Clinical team is continuously conducting studies that result in successful NDA and MAA submissions, all within the program timelines.
Our experience includes: