Success Stories

Rho is not like other CROs

While we enjoy the challenges of traditional clinical trial research, Rho’s team members excel at solving complex, one-of-a-kind issues in an incredibly short time frame. To understand Rho’s distinct approach to problem solving, as well as how we perform our job and deliver an unrivaled customer experience, check out some of our project successes below. They demonstrate how we’ve become the preferred CRO for some of the most dynamic pharmaceutical, biotech, and medical device companies in the industry.

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Experienced and effective clinical trial management delivers phase III pain trial ahead of schedule

Situation: A phase III bunionectomy trial

The Success:

  • Strong site relationships and experienced CRAs helped them complete enrollment of the trial's 500 subjects 7 weeks ahead of schedule.
  • A dedicated study start-up team ensured that all IRB approvals were in place within three months and that site contracts were negotiated and fully executed within 2 weeks of IRB approval.
  • Through the highly coordinated efforts of our data management professionals, the database was locked a full month ahead of schedule.

Overall, our Sponsor was incredibly pleased with the successful execution of their trial.

Close collaboration between the Rho team, the Sponsor and sites results in study completion a month ahead of schedule

Situation: A phase III ADHD laboratory classroom study

The Success: For a phase III ADHD laboratory classroom study, we:

  • Completed enrollment early
  • Reduced time from last patient last visit to database lock
  • Produced top line results two days after database lock
  • Completed the study more than a month ahead of schedule

We achieved these results by:

  • Selecting experienced central sites
  • Setting site start-up expectations during qualification visits
  • Using online ADHD assessment tools that reduced effort for sites and parents and reduced errors in scoring
  • Using sites experienced in EDC
  • Understanding the sponsor’s goals to deliver top lines as soon as possible after database lock

Completing enrollment early for a phase III rare disease study

Completing enrollment early for a phase III rare disease study

Situation: A phase III study in a rare disease

The Success:

On a recent phase III study for a rare disease, we randomized all 120 patients 4 weeks ahead of schedule.  How were we able to do this?

  • Creating a critical path map showing all tasks needed to reach the next milestone (e.g., site activation, FPFV)

  • Sharing this map with all team members, sites, and vendors

  • Collaborating closely with a patient advocacy group for the rare disease in question

  • Maintaining frequent and close communication with all stakeholders

This study included 37 sites across 5 countries. As a result, a treatment that has the potential to fulfill an unmet medical need for a serious rare disease is one step closer to being available to patients.  

Rho works with patient advocacy group to build and maintain strong relationships with key sites

Rho works with patient advocacy group to build and maintain strong relationships with key sites

Situation: Phase III cystic fibrosis study 

The Success: When it comes to cystic fibrosis studies, it is critical that CROs build and maintain strong relationships with sites.  Following study start-up for a phase III cystic fibrosis study being conducted by Rho, the Cystic Fibrosis Foundation Therapeutics Development Network (TDN) conducted a survey of participating sites to assess their satisfaction with Rho.  Some of the highlights:

  • 100% of sites ranked Rho as good or excellent for 6 of the 7 questions asked.  For the seventh question, 90% of sites ranked Rho as good or excellent.
  • On all questions, Rho scored higher than the TDN average.
  • “Rho is tremendous; their people put in the extra effort to get our site initiated over a weekend in order to make it easier for a subject.”
  • “At this moment, they are pretty near perfect as far as I can tell.”


Effective clinical trial management and regulatory expertise leads to FDA approval of unique product for ADHD

Effective clinical trial management and regulatory expertise leads to FDA approval of unique product for ADHD

Situation: Full-service management of two phase III ADHD studies + NDA Submission = FDA Approval

The Success:

  • Initially contracted for End of Phase II meeting support due to ADHD expertise, which lead to full service management of both phase III studies and subsequent NDA authorship and submission.
  • Study # 1: Laboratory Classroom Study leveraged existing relationships with Rho’s go-to network of experienced classroom sites and training consultants. 
  • Study # 2: Examined a novel endpoint to address unmet need/gap in typical coverage period for existing ADHD medications.
  • Seamless team integration between clinical monitoring, data management, and biostatistics to identify early data trends leading to training reinforcement needs for new endpoint scales.
  • Produced topline results within 24 hours of database lock.
  • Parallel development of Clinical Study Reports and Safety/Efficacy modules to support efficient NDA submission.  Successful label negotiation with FDA.    

Rho and the sponsor jointly navigated a new pathway from initial End of Phase II planning to phase III trial execution to delivery of quality data to support FDA approval.

Delivering topline results 36 hours after database lock

Situation: A phase IV pediatric study

The Success: Our Sponsor was thrilled when we delivered extensive final topline safety and efficacy results 36 hours after database lock. It didn’t come at the cost of data quality. We had zero randomization, treatment assignment and treatment errors with a BID dosing regimen that required some kids to receive medication at school. Also, subject retention was 100%.

Overcoming enrollment obstacles to exceed Sponsor expectations

Situation: Phase III dental trial

The Success: our project team was able to overcome enrollment obstacles and exceed sponsor expectations. We started the study using all sponsor selected sites. Many of these sites had no previous experience with clinical research, and early on we saw some issues with patient recruitment. Our project team took the following actions to make sure that quality data was collected and enrollment goals and timelines were still met:

  • We conducted in-depth GCP training for all sites during the site initiation visits.
  • Monitors were on-site during the first study visit where subjects were randomized to answer questions and to make sure study procedures were being followed.
  • Based on our recommendation, the sponsor added several high performing sites we had used in the past. These sites exceeded enrollment expectations and routinely outperformed the original sites.
  • We surveyed the sites to identify recruitment hurdles and ensure efforts to bolster recruitment were effective and tailored to the sites’ specific issues.
  • We held regularly scheduled calls with site study coordinators to share best practices as well as identify and fix issues. We routinely saw spikes in enrollment following the calls.

Achieving success after rescuing a neglected study

Situation: Rescuing a phase III periodontal study

The Success: We rescued a phase III periodontal disease study after a nine month gap with no study activity. We inherited over 600 casebooks of data that had not been entered or monitored. We got the study back on track by:

  • Getting all backlogged data entered and cleaned
  • Assisting the sponsor with discussions with FDA
  • Catch-up and new visit monitoring, including having monitors on site during patient visits. The CRAs worked closely with the DM lead to ensure all queries on old data addressed and verified.
  • Holding a new kick-off and training to retrain and re-energize sites and ensure their on-going effort

Meeting timelines in a small patient population

Situation: A phase II orphan drug study

The Success: During a challenging phase II study with a small patient population using visual analog scales, diary data, and patient workbooks, we were able to meet all timelines and exceed sponsor expectations by:

  • Maintaining strong relationships with the sponsor and sites
  • Utilization of support groups to assist in referral and recruitment efforts
  • Selecting experienced, high enrolling sites
  • Utilizing previous experience in both the therapeutic area and with diseases with small/special populations

Delivering high quality medical writing ahead of schedule

Situation: A phase 4 open label study needed to meet a commitment to FDA

The Success: A Phase 4, open-label, 52-week safety and efficacy study of a marketed oncology product was conducted as part of a commitment to FDA to extend the safety data available in the specified patient population beyond 6 months.

The sponsor had previously committed to FDA that the clinical study report (CSR) for the study would be submitted by the end of Q2. The sponsors had several significant delays, yet we were able to meet their needs by adding resources and working closely with the sponsor to address any questions during the generation of the draft CSR. The final CSR was delivered one week ahead of schedule!

Throughout this project, the sponsor commented on Rho’s attention to detail and clear communication. The Sponsor’s Research Study Manager said, "We are very pleased with Rho's efforts in this project. The medical writing has been excellent!"

Preparation and Collaboration Result in Successful Advisory Committee Meeting Outcomes

Situation: NDA submission and an FDA Advisory Committee meeting for a pain and addiction product

The Success: We supported a client’s successful FDA Advisory Committee Meeting regarding a pain/addiction product for which we prepared the entire NDA submission. To assist the client with their meeting, we:

  • Created more than 100 new displays to support core and backup slides
  • Proposed a new ad hoc analysis which was used in the core presentation and directly addressed some FDA concerns
  • Provided on-demand analyses leading up to and during the meeting

For the 4 questions posed, the Advisory Committee gave a majority favorable finding for all of them. There was also a formal discussion point regarding potentially critical application deficiencies, and the Advisory Committee deemed all of them not-critical.

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