Analgesia
Post-Op Pain
Committed to Research in Acute Pain and Post-Operative Surgical Models
To be successful in the acute post-operative pain space, you need a CRO partner with a demonstrated track record of success. The experience required comes from years of developing relationships with KOLs and their high-quality, high-enrolling sites, successfully navigating FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP), and maintaining a team of experts in acute pain who know how to execute these fast-enrolling studies.
Why Choose Rho?
Our experts understand both the challenges and FDA requirements for using surgical models in the development of products to treat acute pain, including the need to incorporate Human Abuse Assessments.
Our operational experts can handle the fast enrollment of these trials, which requires contemporaneous monitoring and real-time communications with sites. They know the ins and outs of handling scheduled substances, and they provide fast start up and a data cleaning strategy that will ensure enrollment and database lock timelines are met, and often exceeded.
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 (HAP) issues.
Expertise in Action
Rho’s team of post-operative pain experts routinely complete enrollment of clinical studies ahead of schedule. Some recent examples include:
- Completed enrollment 7 weeks early for a Phase III Bunionectomy trial with 500 subjects.
- Locked a database for a Phase II Bunionectomy trial a full month ahead of schedule.
- Completed enrollment 3 weeks ahead of schedule for a Phase III Abdominoplasty study.
- Successfully negotiated with DAAP on the primary estimate for multiple pivotal trials.
- Completed enrollment 4 weeks early on a Phase II molar extraction study with 108 subjects.
50+
clinical sites in the acute pain space
9
products reviewed by FDA’s pain division (7 approved)
30+
FDA Type A/B/C meetings in the pain division
6
advisory committee meetings in the pain division (both back room and bullpen)
Completed studies in recruited surgical pain models, including
- 3rd molar extraction
- Abdominoplasty
- Anesthesia induction
- Bunionectomy
- Hysterectomy
- Inguinal hernia repair
- Total knee arthroplasty (TKA)
- Ventral hernial repair
Human Abuse Potential
- Design and operational conduct of HAP studies
- Statistical considerations and powering of HAP studies
- Clinical data analyses needed in HAP studies
Assessments
- Patient Reported Outcomes – paper and electronic
- Double stopwatch
Scales
- VAS
- NRS
- Likert pain scales
- Global impression scales
- LAST
- Southampton and other assessments of wound healing
Endpoints
- Number of Events per Time period
- Opioid Sparing
- Time to Resolution/Resolution in xx hours
We’ve worked with
250+
clinical sites who focus on pain trials
25+
years in the acute pain clinical development space
A Sample of Recent Acute Post-Op Pain Experience
Phase | Sites | Patients | Indication |
IIa | 1 | 20 | Abdominoplasty |
III | 5 | 300 | Abdominoplasty |
III | 2 | 60 | Bunionectomy |
III | 16 | 400 | Bunionectomy |
III | 3 | 83 | Bunionectomy |
III | 6 | 522 | Bunionectomy |
III | 4 | 375 | Bunionectomy |
III | 3 | 340 | Bunionectomy |
II | 5 | 320 | Bunionectomy |
III | 1 | 125 | Bunionectomy |
III | 3 | 300 | Bunionectomy |
II | 2 | 45 | Hernia |
III | 11 | 159 | Hernia |
III | 24 | 319 | Hernia |
III | 16 | 412 | Hernia |
III | 25 | 500 | Hernia |
II | 6 | 45 | TKA |
III | 6 | 154 | TKA |
II | 1 | 52 | Dental |
II | 1 | 110 | Dental |
III | 2 | 110 | Dental |
III | 20 | 399 | Anesthesia Induction |
III | 20 | 399 | Anesthesia Induction |
II | 2 | 45 | Hysterectomy |
II | 6 | 18 | Hysterectomy |
[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
Webinar
Challenges with Fast Enrolling Post-Operative Acute Pain Studies
There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly? Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution.
Watch Webinar
Becky Baggett
Senior Project Director
Ben Vaughn
Chief Strategist, Biostatistics & Protocol Design
Featured Content
Thank you to the entire Rho team for locking this database on time! I truly appreciate the team’s dedication and hard work to get our acute pain program to this important milestone, despite challenging timelines.
Director, Clinical Operations
Success Stories
Join us on our mission to bring relief to the millions in pain. We proudly invite you to experience Rho.
