Analgesia
Chronic Pain
Committed to Better Outcomes for those Suffering from Chronic Pain
Chronic pain can be debilitating, which is why Rho has been committed to clinical development for treatments of chronic pain for more than 25 years. Chronic pain studies can be complicated and challenging, and they have very specific requirements and expectations from FDA, including the need for Human Abuse Potential/Human Abuse Liability Assessments. Our team of pain experts knows how to design and execute successful chronic pain studies, as well as how to navigate FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP).
Why Choose Rho?
Having a history of delivering chronic pain programs ahead of schedule, our operational experts are well-versed in the challenges of these complex studies. Our teams have years of experience overcoming and mitigating issues with subject retention, diary compliance, rescue medication, scheduled drug handling, diagnosis/severity ratings, and blinding issues that are common to chronic pain programs. Our regulatory experts have helped sponsors achieve product approval in this competitive space by interacting with FDA’s DAAP on their behalf, providing insights into development programs and protocols, and advising on Human Abuse Potential/Human Abuse Liability (HAP/HAL) issues.
Expertise in Action
- Completed enrollment six weeks early on a large Phase III OA of the knee study
- Utilized ePRO to maintain daily pain/medication diary compliance rate in excess of 90% over 6 months
- Quickly pivoted to implement remote study options for a Phase II study at the outset of the COVID 19 pandemic, limiting dropout rates to less than 5%
We’ve worked with
250+
clinical sites who focus on pain trials
Rho has experience with
- Fibromyalgia
- Osteoarthritis including knee, shoulder, and small joint
- Migraine
- Musculoskeletal including low back pain
- Neuropathic pain including DPN and PHN
Scales
- BPI (DPN and PHN)
- KOOS
- WOMAC
- Oswestry Disability Index (ODI)
- Roland-Morris Disability Questionnaire (RMDQ)
- Patient and Clinician Global Assessments
- Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Endpoints
Our experts are proficient in the agency’s expectations for appropriate endpoints, calculations, and imputation. This includes strategic guidance on endpoint ordering to help sponsors obtain the broadest possible labeling.
Featured Content
We could not be more proud of the operational excellence Rho provided in the planning and execution of our Osteoarthritis trial. We have been successful in each step of the trial, including achieving FPI early, completing enrollment 3 months early, and adjusting and pivoting our protocol and operations.
Biotech Clinical Operations Leader
A Sample of Chronic Pain Experience
Phase | Sites | Patients |
I | 8 | 36 |
II | 17 | 180 |
II | 18 | 100 |
III | 60 | 600 |
III | 55 | 272 |
III | 40 | 800 |
II | 90 | 518 |
III | 13 | 100 |
III | 65 | 416 |
III | 50 | 600 |
III | 93 | 320 |
[Rho] staff have been a joy to work with over the years. Rho separates themselves from their competition with a lack of turnover of key personnel, including project management, and the training they provide to both their in-house and contracted CRAs.
Patrick McLaughlin, CEO, Anaheim Clinical Trials
Success Stories
Join us on our mission to bring relief to the millions in pain. We proudly invite you to experience Rho.
