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Jamie Hahn

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Why Rho has Lower Turnover Rates than Most Contract Research Organizations

Posted by Jamie Hahn on Tue, Sep 17, 2013 @ 04:24 PM
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Jamie HahnJamie Hahn, Senior Director Corporate Communications, has worked at Rho for eight years.  In addition to corporate communications, she has worked in project management, data management, and proposals & contracts.  Here Jamie shares her personal take on why she, and many others, choose to stay at Rho. 

I’ve worked at Rho for eight years now, which might seem out of the ordinary for an employee of a contract research organization (CRO). In fact, it doesn’t just seem out of the ordinary, it actually is out of the ordinary. Based on preliminary results from the 15th annual CRO Industry Global Compensation and Turnover Survey*, U.S CROs continue to be plagued by a high employee turnover rate. 18.6% for 2012, to be exact. Wow. Clearly CROs are having serious trouble retaining talent, which is a huge problem in an industry that relies on human capital so heavily.

When I saw these numbers, I immediately called our HR group to find out our turnover rate for 2012. As I waited for the final numbers, I ran through some of the anecdotal evidence I’ve collected on this topic. On my walk to the water fountain, I pass four people who’ve been here for at least three years. There are always employees celebrating 1, 5, 10, and 15 year work anniversaries. And many of us worked in the basement of Ron and Mary Helms’s house in Chapel Hill when they first started the business. Certainly, we could beat a turnover rate of 18.6%.

HR sent me the numbers, and Rho’s turnover for 2012 was a mere 9.7%, just about half the percentage reported in the survey. They also let me know that more than 50% of our employees have been with the company for more than 5 years. I was stunned by these numbers, especially in light of the recent CRO survey results. Being in Corporate Communications, I was curious about the story behind the numbers and why Rho is so different from the rest of the CROs in the industry. Quite simply, I wanted to know why our employees stay at Rho.

So, we asked them. Through a survey that was sent to all employees (response rate of 77%), we received some wonderful and enlightening answers. Here are some of our favorites:

“I enjoy working with smart people.”

“Working in a stimulating environment with motivated team members.”

“Flexibility. Flexibility. Flexibility.”

“My colleagues are amazing.”

“Reasonable hours. This is a great company for family people.”

“Warm, relaxed atmosphere.”

“My work. I love what I do here at Rho.”

“Questioning the status quo is encouraged.”

“Being able to contribute to the greater good and using my brain 5 days a week.”

“Latitude to influence the makeup of my job.”

“My work is valued and my ideas matter.”


rho superheroAdditionally, we asked, “What do you do at Rho?” The top three answers were, “I solve problems,” “I make people happy,” and “I make the world a healthier place.” Not bad for a day’s work.

Around this time, we were also notified that Rho had been recognized by three organizations for our family-friendly, flexible, and all-around exemplary workplace in 2013. These awards included the Triangle Business Journal’s Best Places to Work award, the Sloan Award for Business Excellence in Workplace Flexibility, and the Carolina Parent Family-Friendly 50 Award.

All in all, I’d say that Rho is a great place to work. As a communications professional who’s been charged with sharing Rho’s story with the industry, I’m glad to be able to back up this statement with hard evidence from the industry turnover survey, our employees’ own words, and our recent workplace awards. I love telling Rho’s story every day, but sometimes it tells itself.

*The CRO Industry Global Compensation and Turnover Survey was conducted by HR+Survey Solutions

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Choosing the Right System for your Clinical Trial: Understanding the Differences between EDC and IVR/IWR

Posted by Jamie Hahn on Tue, Apr 09, 2013 @ 09:05 AM
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headshot steve palmatierThe following article was contributed by Steve Palmatier, Rho's service leader for Interactive Response Technology (IxR) system configuration and development.

Sometimes it's difficult to determine the best tool for a job, especially when technologies are developed in parallel to handle similar tasks.  Take Interactive Response Technology (IxR) and Electronic Data Capture / Electronic Case Report Forms (EDC), for example.  Both technologies provide a method for electronic entry of important data.  Both can have data verification checks incorporated to minimize the potential for ambiguous or incorrect data entry.  Both commonly incorporate user roles to limit access of individual users to functionality that is appropriate.  So what are the differences that would provide insight on which technology to use when?  Several areas of differentiation are outlined below.

Purpose of the System

EDC - In short, EDC systems’ primary purpose is to electronically collect and validate participant data for eventual use in statistical analyses.  Collecting these data electronically makes them more quickly available to the study team than traditional paper CRFs, and therefore allows more informed and proactive decision making.

IxR – The goal of IxR in clinical trials is to perform specific tasks, such as randomization, study drug dispensation, study drug resupply requests, emergency unmasking, etc.  It is not the goal of IxR in most cases to be the primary place where participant data are entered and stored, though some data are required to perform the aforementioned tasks.

System Interface

EDC – Due to the sheer volume of data to be captured, EDC systems nearly always use a computer-based interface that allows users to easily navigate between forms and between different areas on the same form.  While swift entry of data into EDC systems is often desired so that study teams have accurate enrollment information, it is not usually operationally critical, so it is acceptable for a user to enter data in not-quite-real-time.  Moreover, most clinical sites in developed countries can be expected to have computers, so a computerized interface is acceptable the vast majority of the time.

IxR – IxR has two main interfaces: web and voice (IWR and IVR respectively).  Over the past 10 years or so, the prevalence of IVR systems has decreased significantly due to workstations, laptops, smartphones, and tablets becoming more widely available in the clinical setting.  However, there are still some instances in which the phone interface is beneficial, such as when entry of data for randomization is highly time-sensitive (e.g., in neonatal trials where randomization must occur very shortly after birth), and when the IxR will be used for patient-reported outcomes or diary entry, since study subjects may not have access to a computer at home.

Navigation Paradigm

EDC - Most EDC systems are form-based, and most of the data entry fields on any particular web page are static.  When a participant is enrolled in a trial, a set of forms is made available into which that participant’s data will be entered.  Whether these forms are necessary or not becomes apparent later.  For instance, if a participant withdraws consent early in the study, there may be many forms for visits later in the study that never have data associated with them.  In many cases, the order in which data are entered is not controlled since different data will become available at different times, though sometimes additional forms are generated as they become necessary (e.g., SAE forms).

IxR - IxR systems generally create data entry pages dynamically.  That is, the information and entry fields that appear on-screen or that are prompted over the phone are a result of previous selections and entries made by the user.   This both minimizes data entry by the user and provides a gating mechanism that forces things to happen in the correct order.  For instance, a user cannot skip to kit assignment prior to randomization, or randomization prior to entry of valid stratification data.

User Modification of Previously Entered Data

EDC - EDC forms can usually be revisited multiple times because all of the data that are to be entered on a form may not be available at once (e.g., lab values).  Often, entry of data that seems inaccurate or is in an incorrect format is accepted and stored but fires a query that must be resolved prior to database lock, and the user may return at a later time to correct or confirm the entry.  This is consistent with the primary purpose of EDC, to store data for use in data analysis that will take place at a later date.

IxR - Unlike EDC forms, entry of data and completion of a function in IxR usually triggers an action that is based on the entered data, so it is uncommon for a user to be able to return to the system to make corrections of previously missing or incorrectly entered data without support intervention.     Incorrect entry of stratification data prior to randomization has cascading impacts, so correcting the mistake often involves more than simply updating that one data point.

Validation Burden

EDC – Because there is an opportunity to correct mistakes between the initial entry and database lock, the importance of correct and complete data at the time of entry is not often assessed to be at the highest level.  Also, since the primary purpose of EDC is to store data rather than to perform actions, validation of the system can focus primarily on making sure that edit checks fire correctly and that the data is stored accurately.

IxR - Because IxR performs actions that impact the course of the study, IxR systems generally carry a higher risk than EDC systems.  Not only is it important for validation efforts to ensure that the entered data is correct; but it is also important to validate the logic that is exercised in order to make the decisions and perform the actions that are based on that data – assigning the correct treatment kits, requesting resupply of investigational product when appropriate, enforcing cohort caps, etc.  The result is that IxR systems (especially those that are highly configurable) generally require more extensive validation and a higher percentage of setup time allotted to validation activities.

In the next post in this series, we’ll use these distinctions to help determine the appropriate scope for IxR systems so that the technology can be used most advantageously.

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Kudos for Rho’s Clinical Trial Management Teams

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

Which Type of Contract is Right for your Clinical Research Project?

Posted by Jamie Hahn on Mon, Nov 05, 2012 @ 10:02 AM
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contracts 101You've chosen a contract research organization (CRO) to partner with on your next clinical research project or program, and now it's time to sign a contract. It's important to be familiar with the different types of contracts and payment schedules, so that you can have an open discussion with the CRO about which is the best fit for your company and your project. It's always ideal to put a contract and payment schedule in place that is mutually beneficial for the CRO and the Sponsor.

The following is a description of the different types of contracts and payment schedules and when it's best to use each. 

Milestone Based Fixed Price Contracts

These are very typical contract forms which are used frequently for clinical research projects. As the name implies, the CRO offers the client a fixed price to complete the agreed upon scope of work. Therefore, if the CRO spends more hours than expected to complete a task, the CRO absorbs those additional costs.

If the scope changes, both parties agree on a price increase or decrease for the change. These contracts are referred to as milestone contracts because the payment schedules are made up of dollar amounts associated with pre-negotiated “milestones.” A billing occurs each time a milestone is achieved. For instance, in a contract that includes clinical monitoring, one of the contract milestones might be “Upon 50% Enrollment” - $X. In this case, we would bill $X on the date that 50% of the patients are enrolled in the study.

These contracts are generally used when the scope of work is well defined between the CRO and the sponsor, and the sponsor wants to have a high degree of certainty related to its necessary cash outlays.

Variable Price Fixed Unit Contracts

Unlike milestone based fixed price contracts, the total price of a unit based contract may vary. However, a fixed cost is agreed upon for all defined units. For instance, if the CRO is providing biostatistics services, they may agree to a price of $10 for each unique table that is delivered.  In addition, they may estimate that they will provide 10 unique tables for a total price of $100.  If during the course of the study, the client realizes that they will need 12 unique tables, they would be billed $120 without preparing a contract amendment.

Variable price fixed unit contracts are particularly useful when the scope of the contract may expand or contract based upon outcomes of the study.

Time and Materials Contracts

These are the simplest form of contract. In time and materials (T&M) contracts the CRO bills for actual hours at agreed upon rates. The roles and rates are defined in the contract. As an example, if a Clinical Data Associate (CDA) works for 10 hours on a T&M project and the agreed rate for a CDA is $10/hr, the client would be billed $100 dollars. T&M contracts generally have a contract cap that defines the limit of dollars that can be billed under that contract.  

Time and materials contracts are very useful when the scope of the project is undefined.

3 Benefits of Combining Clinical Data Management and Biostatistical Services

Posted by Jamie Hahn on Thu, Oct 25, 2012 @ 01:56 PM
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woman celebratingIn some cases, we're asked to provide services for just one piece of the biometrics component of a clinical trial project or program, such as clinical data management services OR biostatistical services. While in theory this set-up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the clinical data management and biostatistical components for your clinical trial project or program. 

When one CRO provides both clinical data management and biostatistics services for a trial, you can benefit in the following ways:

1) Well-designed database and less re-work

Clinical data management and biostatistical experts collaborate from the earliest stages of study start-up. Early collaboration on CRF design, clinical database set-up, and the clinical data validation plan ensures that the clinical data will support your objectives and reduces the potential for costly statistical re-work associated with an unfamiliar or poorly designed database.

2) Cleaner data

Experienced clinical data managers can provide databases with error rates far below industry standards. Focusing on building quality into every clinical database from CRF design through database lock will ensure that data issues, errors, and anomalies are minimized, and any data errors that do occur will be found early in the process. The earlier data errors are found, the less expensive these errors are to fix. When a clinical database has been designed well and the clinical data management process has been executed successfully, the biostatisticians have many fewer data errors and anomalies to investigate and correct, thus saving you time and money.  

3) Better traceability of data and potentially faster approval

When clinical data managers and biostatisticians collaborate early in the clinical trial process, they can focus on creating clinical, SDTM, and analysis databases in a manner that amplifies the traceability of data. Planning for the use of CDASH, SDTM, and ADaM standards from the start will increase traceability, facilitate FDA review, and potentially expedite approval timelines. 

What benefits have you noticed when one contract research organization supports both the clinical data management and biostatistical services for your clinical trial project or program? 

 

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4 Tips for Planning the RFP Process for Clinical Trial Services

Posted by Jamie Hahn on Tue, Aug 14, 2012 @ 02:49 PM
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gearheadBefore you request bids from contract research organizations (CROs) for clinical trial services, it’s important to spend time planning your request for proposal (RFP) process. It’s easy to neglect this planning step, especially since the other deadlines and pressures of the drug development and/or research process often take precedence. However, even the smallest amount of planning prior to the RFP process can reduce the amount of time you spend reviewing proposals and increase your ability to request clarifications from participating CROs.  

Here are some things to consider prior to the RFP process for clinical trial services:

1. Give the CROs at least 5-10 days to provide a bid. Plan ahead so that you can do this. The more time allowed for CROs to respond, the more complete and thoughtful the responses will be.

2. Determine a timeline for the RFP process, including: 

  • Due date for questions about the RFP from CROs.
  • Due date for your responses to the CRO questions.
  • Due date for responses to your RFP.
  • Date for the completion of your review of all CRO responses.
  • Dates for bid defenses for all contending CROs.
  • Date for final decision on selected CRO.

3. Determine selection criteria and provide that information to the CROs. For example, “The CRO will be selected based on responses to this RFP and the following criteria:

  • Quality of the response to RFP, including the quality of comments and suggestions.
  • Experiences/skill level of company representatives assigned to this project.
  • Quality and applicability of proposal presentations at bid defense meeting.
  • Demonstrated understanding of the indication.
  • Well-developed strategies for avoiding or effectively managing common drug development and clinical trial hurdles.
  • Value for the cost of service proposed.
4. Consider how you plan to receive and respond to CRO questions – Individually? As a group? In any format? In a prescribed format? We recommend providing a template and sending all the questions and answers to all participating CROs.
What else have you found useful in the RFP process? What would you add to our list?

 

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5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

Posted by Jamie Hahn on Tue, Jun 05, 2012 @ 11:46 AM
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tool for clinical trial servicesIf you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are five tips for creating RFPs that will help you compare “apples to apples” and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

1. Provide background info on your compound and program

2. Provide a protocol or protocol synopsis

3. Provide detailed RFP information to get consistent costs. Be specific. Some examples, might include:

  • Project specifications – What are the important details of your program? (Use our RFP specifications tool)
  • Project timelines – By when do you expect certain milestones to be met?
  • Responsibilities (CRO, sponsor, other vendors) – For which segments of your program do you need a CRO to provide clinical trial services?

4. Provide additional details. The more details you can provide the better.  It’s also OK to ask the CRO to make recommendations. You can tell a lot about a CRO by the recommendations they make and how they make them.  However, if you ask CROs to make recommendations be prepared for potential inconsistencies in the assumptions made and pricing offered between different CROs. The following are some additional details that might be helpful to bidders:

  • Paper or EDC?
  • Data output in CDISC format?
  • Provide site locations
  • Central or local labs?
  • Additional vendors (specialty labs, IRBs, translations, etc)?
  • Interim analyses, DSMBs, etc?
  • Automated subject randomization and clinical trial material re-ordering and shipping?

If you know you want to use certain specific vendors (i.e. you know you want to use Medidata RAVE for EDC), be sure to include that information.

5. Other items to request from CROs:

  • Project team CVs
  • Summary of team therapeutic experience and experience running similar trials
  • Relevant company information

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