Rho site logo

Rho Knows Clinical Research Services

Update from the top: FDA’s Office of New Drugs ongoing reorganization process

Posted by Karl Whitney on Thu, Jan 02, 2020 @ 11:00 AM

karlKarl Whitney, PhD, RAC, Assistant Vice President of Product Development, leads multiple integrated drug development programs spanning the development spectrum by planning, managing, and overseeing concurrent manufacturing, nonclinical, clinical, and regulatory activities.

Rho representatives joined regulators, industry scientists, and numerous patient-advocacy groups at CBI's Rare Disease Clinical Development & Access conference in Washington 03-04DEC 2019. During an opening plenary session, FDA's Office of New Drugs (OND) director Dr. Peter Stein shared comments and took questions from the audience. Participants asked a number of questions that indicate a high degree of interest in (and, perhaps, some anxiety about) OND's ongoing reorganization in general and as it might affect specific current projects at the IND or NDA review stage. This reorganization was announced earlier in 2019 and will, among other things, increase the number of offices overseeing review divisions from 6 to 8, and split and/or redesign review divisions to increase the number of divisions from 19 to 27. The reorganization is being implemented in four phases, with the last set to complete by February 2020. Dr. Stein certainly attempted to address some of the audience's concerns. His key message: the ongoing reorganization is intended to improve review processes while ensuring continuity for individual projects. In short, FDA doesn't want to fix what ain't broke.

Instead, the overall goals are to establish more therapeutically aligned, integrated review teams that take an interdisciplinary and 'problem-focused' approach to reviews; and to modernize and standardize review processes across divisions. In the process, he and hOptimization - Business Concept. Golden Compass Needle on a Black Field Pointing to the Word Optimization. 3D Render.is team are taking great care to ensure OND operates smoothly, and that review teams have a re-energized scientific focus for their work.

On the former, he hopes the reorganization will make for more sensible Division groupings. Some large divisions such as Neurology or GI/inborn errors are being split up so that Division Leadership can spend more time on the science and be more externally facing  (eg, at conferences). Individual review teams are being kept together as much as possible when these new divisional groupings are being designed. Further, he has instructed Division heads overall to avoid revisiting prior agreements made between the sponsor and the review team if the team has moved divisions. He believes strongly that it's in nobody's interest to upend established agreements, though he reminded the audience that of course, FDA reserves the right to update its positions as new data accrue. So, sponsor caveat emptor.

On the latter, OND is trying to enhance reviewer consistency and throughput by using a new review template and improved processes that support efficient, integrated reviews of submissions from IND through to approval/post-approval. In addition, a new non-review office called Office of New Drug Policy has been established to support review teams when novel Orange Business Processes Button on Computer Keyboard. Internet Concept.issues come up that lack clear guiding precedent, so that review teams across the OND approach novel issues with greater consistency. Another new cross-cutting office of interest to conference attendees is the planned Division of Rare Disease and Medical Genetics within the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. This group will not have direct review responsibilities but rather will offer 'consultative support' to help review teams properly exercise 'flexibility' in product development programs for example in terms of expected safety database size, a topic that commonly arises, naturally, with rare disease development programs. These rare-disease sponsor projects will still be overseen by the Division that makes the most sense from a therapeutic area - for example, Division of Anti-infectives. The new Division of Rare Disease and Medical Genetics group will also have a mandate to engage outside FDA with patient groups, other regulatory bodies, academia, and even Advisory Committees to ensure they understand realities for rare disease product development. One can only speculate as to why these new responsibilities were not assigned to the longstanding Office of Orphan Product Development.

Overall, the audience took a wait-and-see approach insofar as the reorganization is ongoing and the chips haven't fallen yet. Time will tell if the major goals of the reorganization are achieved by this structure, but Dr. Stein certainly made his best case for the various rationales for the temporary upheaval. Maybe spring cleaning came a bit early to the OND this year....


4 Reasons Low Employee Turnover Is Critical in CRO Selection

Posted by Brook White on Fri, Jun 03, 2016 @ 11:48 AM

Employee turnover rates across the CRO industry are incredibly high.  In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs.  As a Sponsor selecting a CRO, why should this matter to you?  The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project.  Project team stability can have a significant impact on the quality of execution, ability to meet timelines, the amount of time and energy you will need to put into oversight, and site relationships. While no CRO can guarantee zero turnover on your team, the ideal situation is that the team you meet during the selection process will be the same team present during study start-up and the same team at project close out.


quality.jpgClinical studies are complicated.  Over the course of a study, team members become entrenched in the details of the study—understanding the protocol, knowing the details in study plans like the data management plan and the clinical monitoring plan, and participating in investigator meetings and other study specific training.  As a result, things run smoothly.  Problems are less likely to be missed, risks are identified earlier, and fewer errors are made.  There is a human aspect as well.  CRAs that have a chance to develop relationships with their sites are more likely to catch on when something is amiss.  They know which sites may need a little more attention to keep up with enrollment projections.  Strong working relationships between functional area leads mean smoother hand-offs as well.  When the data manager and biostatistician have been working together from the outset, there are fewer surprises when it comes time for database lock.


time is moneyNew team members mean additional training, time spent reviewing study documents, and time getting up to speed on the study.  Even if it is a fixed price contract so there is no direct cost impact, the additional time spent on team member transitions may very well impact key milestones.  

Increase in oversight

oversightYour time is valuable.  As a Sponsor, you have a responsibility to provide oversight for your study.  With a stable team and proven track record, it is likely that over the course of the study you can back away from the level of oversight you are providing—how much time you spend reviewing status reports, how much detail you need in your reports, how frequently you meet with your CRO.  However, when key team members leave and new ones are added, the risk increases which means your scrutiny needs to increase.

Site relationships

handshakeSites that meet their enrollment projections and produce high quality data are crucial to the success of your clinical trial.  Consistent communication and strong relationships with their assigned CRA are needed to get the best performance out of your study’s sites.  If their CRA or other main contacts keep changing, it is hard to build and maintain those relationships.

Given that low turnover is so important, what can you do?  When it comes time to select a CRO for your next clinical study, make sure to ask about turnover rates, and specifically, about CRA turnover.  You should look for a CRO with an overall turnover rate around 10% and a CRA turnover rate of less than 15%.  Pay particular attention to the longevity of key team members.  Look for a team where most of the key team members have been with the company at least 3-5 years.  Finally, talk to prospective CROs about what they are doing to ensure team stability and how they will handle any turnover that happens during your project.

5 Tips for Creating an RFP

Thoughts from Rho’s CEO: Fostering Innovation in a Clinical Research Organization

Posted by Brook White on Mon, Feb 11, 2013 @ 02:58 PM

CEO Russ HelmsThe following article comes from Rho’s CEO Russ Helms who would like to share some thoughts on topics that he sees as important to Rho and our business.

Each year at Rho, we select a company goal intended to further Rho’s core purpose: to improve health, extend life and enhance the quality of life via corporate and research excellence. During 2012, we elected to pursue customer service through innovation as the goal.

Some people have asked, “Can a CRO be innovative?” We can! We’re committed to customer service, and we think one of the best ways to ensure the best possible customer experiences is to make sure our people are constantly innovating. Innovation helps us deliver what our customers need faster and better. We’re also committed to being a good place to work, and we think innovation can help our employees by reducing the mundane aspects of their work and making work more fun. And, of course, innovation helps the bottom line through increased efficiency and cost effectiveness. Maybe we’re unusual for a CRO, but we’re committed to innovation.

I want to share some of the programs we have put in place to foster innovation and to share a few of our successes. The first program we implemented was a series of innovation showcases. We employ smart, talented people, and we wanted the fantastic innovations they were creating to be more visible across the entire company. We created the showcase series to give employees an opportunity to share these existing innovations. The showcases gave employees exposure to innovations they might be able to use and, in some cases, sparked ideas of similar innovations they could implement in their own work. Some of our showcases included presentations on graphic visualization by Agustin Calatroni and a better system for managing documents and communications for data safety monitoring boards (DSMBs) led by Project Director Brandy Lind and business analyst Lee Ann Armstrong.

View "Visualizing Multivariate Data" Video

Our next program for fostering innovation is one we have dubbed “Rho24” modeled on Atlassian’s ShipIt days. The concept is that employees are invited to take a break from their everyday jobs and innovate for one 24 hour period. For 24 hours (10 AM on Thursday to 10 AM on Friday), employees work on any innovation of their choice with the goal of delivering something usable by the end. It doesn’t have to be directly related to their job, only something that is of potential benefit to Rho. We have had two of these events so far, and we’ve been blown away by the number of great ideas delivered and by the tremendous energy the events generated. Fun and useful—a double win! About half of our employees participated in at least one of the events and many innovations that came out of these events are already making a difference in our work. Some examples include:

  • An iOS app to report asthma outcomes
  • Improved reporting for our randomization system
  • A program that pushes out company announcements to the screens of our internal desk phones
  • Tools to facilitate our use of Medidata Rave
  • Converting common on the job training topics into reusable e-learning modules

Some people didn’t complete a project, but were able to do the research or create a prototype necessary to get a larger project started. One example is an iOS app to help clinical study sites determine enrollment eligibility.

We are now piloting the final program, modeled off of Google’s 20% time. This program allows select employees to spend up to 20% of their time working on innovations not directly related to their day to day work. Initially, we selected 14 employees to participate, but we may expand the program depending on the level of success. Our pilot program includes several different models that offer varying levels of oversight and support. This allows us to experiment with several approaches and determine what works best before expanding to a larger group where the costs of failure would be higher. I look forward to seeing the outcomes of this pilot in the coming months.

The 2012 annual goal has been a clear success. We are doing a better job of sharing innovation throughout the company, more of our great staff are engaged in innovation (and they are excited about it!), and we are going to keep doing it. I continue to be interested in how other companies engage employees in innovation. If your company is doing something to encourage innovation, I would love to hear about it. I am also curious about experiments in innovation that haven’t worked out and what you learned along the way, so please share your thoughts and experiences in the comments section.


Thoughts from Rho’s CEO: Our Commitment to Outstanding Customer Service in Clinical Trials Services

Posted by Brook White on Thu, Jan 10, 2013 @ 12:59 PM

Russ Helms-Rho CEOThe following article comes from Rho’s CEO Russ Helms who would like to share some thoughts on topics that he sees as important to Rho and our business.

There is a lot of competition in the world of clinical trials services. One way we differentiate ourselves is by providing our clients with an unparalleled customer experience. To make sure that happens consistently, we have developed 6 customer service principles that guide all interactions with our clients. All employees are trained on these principles, and adhering to them is an expectation of employees in all areas and at all levels.

Rho’s Principles of Customer Service:

Everyone at Rho must practice friendly professionalism. 

  • Good customer service must be consistently delivered.
  • Rho hires individuals who express a commitment to customer service in alignment with Rho’s Customer Service Principles.
  • Customer service - good or bad - is contagious.  Consistently practicing friendly professionalism will not only please customers; it will encourage others to practice friendly professionalism.
  • Building relationships, a key element of customer service, requires friendly professionalism. 

Personal investment is required for great Customer Service.

  • Rho's company culture supports each individual pursuing a career path that is engaging.  Engaged people intrinsically provide great customer service.  It is important for the company to maintain this culture and for the individual to take the responsibility to pursue engagement.  
  • Delivering results is a key part of customer service.  Each individual is responsible for maintaining, seeking, and furthering the technical competence associated not only with his/her current role, but also those roles along the chosen career path.  

The totality of our work and interactions contributes to the quality of the service provided to the customer. 

  • You may never interact with an external client; however, the work you do and the customer service you provide to your colleagues directly affects the customer’s perceived satisfaction.
  • Our customers judge our service based on our results, our relationships, and our impact.  All three of these components of customer service must be excellent in order to be regarded as excellent by our customers.  In other words, our deliverables must be top quality (results), our relationships with customers and colleagues must be built on mutual trust and respect (relationships), and the way we provide our services must be striking and above reproach (impact). 

We must understand the customer’s wants and needs and help them recognize the difference between them.

  • We seize opportunities to exceed the expectations we have negotiated. When we do that we create loyal, more than satisfied, customers.
  • Finding new customers is expensive; repeat customers are good business.
  • A part of recognizing the customer’s needs vs. wants involves a thoughtful assessment of our work processes.
  • Successful client relationships are not one sided, but include partnering by all stakeholders and include a foundation of trust and respect.  

Rho measures, evaluates, and rewards great Customer Service across project, sector, and company lines. 

Leadership at Rho provides the infrastructure that supports efforts to implement Rho’s Customer Service Principles.

  • This includes, but is not limited to: technological infrastructure, vendor selection, and well-defined escalation pathways to eliminate quickly customer service barriers.

Kudos for Rho’s Clinical Trial Management Teams

Posted by Jamie Hahn on Tue, Nov 13, 2012 @ 09:38 AM

teamHere at Rho, creating exceptional customer experiences is one of our highest priorities. We love delighting our customers across all of our clinical trial management projects, and the only better reward than the satisfaction that comes from a hard day’s work is the recognition of a job well done from our customers.

The following are recent compliments we’ve received on our work and our teams. We couldn’t be more proud of our employees and their dedication to our customers and their projects:

“Thank you and your team for doing such a great job. You didn’t just meet our expectations, you exceeded them. All with grace and style. Despite last minute challenges you and your team rose to the occasion. You are indeed awesome. Thank you, thank you, thank you! Of course, this is why I like to work with Rho....we get excellent service.”

"Our journey (clinical study report + filling), which started about 1.5 years ago, thus came to fruition, in a most gratifying way. Rho was a key part of this; thank you all for your contributions, and help, in getting this approval. More sick patients will now have access to [compound name omitted] in a setting where there was no approved therapy before!"

“First and foremost, I must say, the clinical study report draft tables and listings are beautiful. It is very rare for a first draft to be so complete and so easy to read. It is obvious that much time and effort has gone into this comprehensive display of data and summaries. Please thank your team for an excellent job. Congratulations on a job well done.”

"I am THRILLED with Rho! The randomization team was wonderful to work with, met their timeline for launch, and the system is fantastic!"

"AMAZING kickoff meeting! We couldn't be happier with our new team. Thank you thank you thank you!!