Getting Past the Fluff to What Biopharmaceutical Sponsors and Clinical CROs Really Need
Part III: The RFP - Clinical CRO Considerations
Last week we reviewed what biopharmaceutical sponsors need to consider when Requesting a Proposal (RFP) for clinical research services. In this week's blog, we'll uncover some of the sticking points that clinical CROs need to keep in mind when preparing RFP responses.
So let's get straight to the first sticking point. Sponsors need another 112 page proposal like they need a hole in their head. If clinical CROs don't want to be treated like a commodity then it's essential that they differentiate themselves early-on as an invaluable, beneficial resource to biopharmaceutical sponsors.
So, how can a clinical CRO go about distinguishing itself as a valuble resource beginning with the RFP?
- Clinical CROs need to invest time and thought into each RFP, presenting a customized and compelling proposal for clinical research services each time. Sure, some parts of the proposal can be standardized for efficiency, but don't treat the clinical study trial with a one-size fits all approach. Present a well-thought out clinical research management strategy tailored to the sponsor's specific trial needs.
- Differentiate yourself from the competition on something other than quality and price. Quality is a given and differentiating on price is what contributes to the "CROs are a commodity" mindset. If your clinical research management proposal looks the same as everyone else's, then there's no reason to think that you will bring anything unique or of added-value to the trial.
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Thoroughly review and demonstrate a solid understanding of the clinical study protocol and other supporting RFP study documentation. Note foreseeable challenges with the clinical study protocol, investigator sites, patient recruitment or other phases of the trial.
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Include a high-level feasibility analysis and patient recruitment strategy. This is an opportunity to demonstrate your experience and show-off your critical-thinking skills based on similar clinical research management experience. Address feasibility challenges from the standpoint of the clinical study protocol and investigational study drug as well as from the standpoint of the types of investigator sites and geographical locations required to access qualified patients. Touch upon your approach to successfully reach the target patient population and to achieve the clinical study trial's patient recruitment and retention goals.
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Include clinical trial therapeutic experience for your clinical research organization, but more importantly, introduce a solid clinical research project team with deep experience in the therapeutic indication. Summarize each team member's industry experience as well as their experience working on similar studies. At the end of the day, clinical research is about people buying people, so it's imperative that you present the actual proposed clinical research project team and introduce what each member's specific role will be on the clinical study trial.
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Get rid of the feature creatures. Telling them about your clinical research organization's capabilities and services is not enough. Include specific case studies that provide proof of your experience on similar studies. Continually ask and answer the question, "So what? What does this (fill in the blank)mean for the sponsor?" Include or offer to provide references.
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Submit the RFP on time. Don't request extensions unless the initial deadline is unreasonable, in which case, negotiate a later deadline upfront.
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Spellcheck. Spellcheck. Spellcheck. Make sure the proposal is written with one voice, flows smoothly from section to section, has consistent formatting, is grammatically correct and has absolutely no typos or spelling errors. If you can't provide a quality deliverable at the RFP stage, there's no reason to think the study deliverables will be any different.
Once the RFP is submitted, don't let it just disappear (along with the relationship) into a black hole. Follow-up with emails and phone calls, as often as you can within reason, to make sure the sponsor received the proposal and that there are no outstanding questions, issues or concerns that need to be addressed.
Lastly, make sure you articulate your CRO's genuine interest and desire to introduce the proposed clinical research project team in a face-to-face meeting, and ultimately, to work on the trial. There's nothing wrong with asking for the business. We'd probably be shocked to learn how many clinical research organizations have so overly automated their RFP process that they never even bother to ask for the work.
Are you planning to solicit RFPs for your next clinical research management project? Are you in need of a standardized checklist to ensure you develop a comprehensive RFP for clinical research services?
Regardless of whether you plan to include Trio in your next RFP process, please download our free, standardized RFP Assumptions Checklist template to guide your next clinical research management project.
Getting Past the Fluff to What Biopharmaceutical Sponsors and Clinical CROs Really Need
Part III: The RFP – Biopharmaceutical Sponsor Considerations
You've had the face-to-face meeting, and now you're ready to move to the next step - the Request for Proposal, aka the RFP. Just getting to this stage is a major accomplishment because, as we all know, the clinical research market is not only big, but also competitive. According to the Association of Clinical Research Organizations (ACRO), the clinical research organization industry is expected to hit the $20 billion mark in revenue this year; roughly a third of all biopharmaceutical industry research and development spending. However, according to an August '09 report by Business Insights, there are more than 1,100 clinical CROs competing for clinical research outsourcing work worldwide and the top five clinical research organizations account for 55% of the market.
So what's most important to consider when requesting a proposal from CROs?
It's critical that you invest time upfront to make sure you are comparing apples to apples when the final proposals are submitted. You'll save yourself a world of time and frustration on the back end trying to compare various clinical CRO responses in order to get an accurate view and make a well-informed decision. Following are some pointers along this same line of thinking:
- Don't throw a protocol synopsis over the wall to clinical CROs and expect to receive a well thought-out proposal. This will result in many time-consuming questions for you and result in a rough ballpark estimate from your clinical research organizations.
- Invest some time and energy into providing a detailed and specific RFP.
- Pull together helpful documentation that you can share in order to help the clinical CRO prepare a thorough response. Items such as the draft/final protocol, responsibilities checklist, and the CRF contain extremely valuable information.
- Develop a standard assumptions document that you can send out with each RFP. This document will serve as a great checklist for you and help the clinical research organization provide you with a solid and thorough response. The RFP document should include key clinical study trial assumptions such as:
- the number of screened, enrolled and completed patients
- the number of investigator sites
- the number (and location) of countries
- the number of unique and total CRF pages
- the number of SAEs
- the number of tables, listings and figures
- the timeline for the various trial phases, e.g., start-up, enrollment, database lock, final study report
Note: if you don't have all the answers, request guidance and suggestions for a specific area of the clinical study trial.
- Outline clearly what you are looking for in the ideal clinical research outsourcing partner. What do you value the most and what will be the main drivers in the award decision?
- Allow a fair response time. Standard turn-around time is about two weeks. If you want a quality response, then it's important that you give the clinical CRO time to put together a proposal that considers all aspects of the clinical study trial and outlines their proposed team and a solid study execution plan. Be available to field questions and share questions and responses with the pool of clinical research organizations providing proposals. Now's the time to start the relationship off on the right foot and establish a considerate, professional and collaborative partnership. If you want to control the volume of calls and emails, provide CROs with a timeframe upfront to get questions to you. Be sure to allow adequate time to address questions in your turn-around timeline.
Today’s blog looked at points biopharmaceutical sponsors should consider when requesting a proposal. In next week's blog, we'll explore what's important for CROs to consider in the RFP stage.
Getting Past the Fluff to What Biopharmaceutical Sponsors and Clinical CROs Really Need
Part II: The Capabilities Presentation
The face-to-face meeting has been scheduled. So what should you expect from the meeting? What should you plan to take away?
If most biopharmaceutical Sponsors and clinical CROs are honest with one another, the first face-to-face meeting is not always a favorite for some. Similar to a first round job interview, it can make both parties uneasy getting to know one another for the first time. If you are the Sponsor, you may even go into it looking at your watch and wondering if it’s the best use of your time. Don't jump to this conclusion too quickly, however, because the first face-to-face meeting can hold a lot of promise and be a spring board for a long and prosperous business partnership. Take advantage of this meeting to learn what you can about one another’s organizations, clinical research needs and capabilities.
Clinical CRO:
- Don't show up with a ton of generic capabilities slides. The Sponsor has seen a similar variation many times.
- Introduce your clinical research organization enough to establish a comfort level about who you are and what you do, but don't dominate the conversation. Tailor your capabilities presentation to the biopharmaceutical Sponsor's specific clinical research needs.
- Ask questions and customize your presentation to the Sponsor's clinical research outsourcing needs as you go
- Be familiar with the Sponsor’s recent product developments or company news
- Try to know a little about your contact by networking with others in advance
- Identify shared industry relationships, establish rapport and trust quickly
- Differentiate yourself by referencing specific clinical research case studies. Be transparent about past clinical study trial challenges and confidently articulate how your company approached and resolved them. By communicating honestly, not only will you differentiate your clinical research organization, but you'll demonstrate how your company has learned, grown and refined processes based on years of clinical study trial experience.
- End the meeting on time. Thank the Sponsor for their time and establish specific action items for follow-up.
Biopharmaceutical Sponsor:
- Go into the meeting open minded and listen. Ask salient questions to keep the presentation in line with what will drive your clinical research outsourcing decisions
- Be honest about what's important to you, your colleagues and organization. Communicate what your needs are and what you are looking for in an ideal clinical CRO partner.
- Make your discussion richer by conveying as much information about your upcoming clinical study trial(s) as possible. The sooner the conversation can get to the specifics, the quicker you can differentiate between multiple clinical CROs and begin identifying which may be the best match for you.
- Be sure to monitor whether the CRO was responsive and provided you with quality, timely follow-up. Use this "courting" period to test the waters and get a true picture of what kind of quality follow-up you can expect from this clinical CRO in the future. If the clinical research organization can't provide quality, timely deliverables during the pre-award stage, then there's no reason to think that they will post-award.
In Part III of this blog series, we will explore the RFP stage.
Getting Past the Fluff to What Biopharmaceutical Sponsors and Clinical CROs Really Need:
Part I - The Initial Call
Biopharmaceutical Sponsor: Go ahead. Tell the truth. You've been dodging the Business Development sales bullet for months. But you just answered the phone thinking it was a different caller but got snagged by a clinical CRO. He/she would like to schedule a face-to-face meeting in the future to learn more about your clinical research and share information about his/her company.
What do you do next? Consider the following:
- Make the most of the call by being specific about:
- What you expect to get out of the meeting
- What you want to learn / walk away with
- What you do NOT want to hear
- How much time you are willing to give
- If possible, agree to sign a CDA in advance in order to make the meeting conversation more specific, and therefore, more productive
- Prepare questions and important points you want to raise during the meeting
Clinical CROs: Let's be honest. You've been trying tirelessly to get the clinical research or outsourcing professional on the phone for months now. You've sent emails, packages, left voice mails and asked to "drop in" when you're in the area. And now, at last, your contact has just answered the phone.
What do you do next? Consider the following:
- Biopharmaceutical sponsors tend to lump all clinical CROs into a similar bucket. They've heard the same sales pitch and the same capabilities presentations repeatedly.
- Be transparent and "real" on the call. Your tone and attitude can often convey more about you and your clinical research organization than your actual words.
- Get to the point. Say what differentiates you from other clinical research organizations; not by bad-mouthing your competitors, but by saying something compelling and genuinely unique about your organization and services. Focus on the benefits, not on the features.
- Show you are vested. Do your homework on their product and areas of clinical research. Demonstrate your familiarity with the organization and how you might be able to assist them in the future.
- Respect their time. Thank them for their time and ask for a convenient time to follow-up.
Within the clinical research industry, the range of services and the number of service providers has grown vastly the last few decades. As a result, clinical project managers and clinical outsourcing professionals have more viable options when determining how best to conduct and manage their clinical study trials. While a full-service model is sometimes the best fit, sometimes clinical trial functional outsourcing or clinical resourcing is a better option.
When clinical trial functional outsourcing or clinical resourcing is the best model, clinical outsourcing professionals have access to a variety of clinical resourcing providers. However, not all staffing agencies are created equal. The clinical research industry is unique and complex. It takes years to master the roles involved with clinical study trials. If you need a single clinical project manager or medical writer or a team of clinical CRAs, a large, generalized staffing agency is not always the best answer. While they do offer experience with personnel placement and typically have access to thousands of candidates, they typically don't understand the nuances of clinical study trials or have access to professionals with the right set of skills and experience. Finding clinical research professionals with the right clinical research industry experience or therapeutic expertise is not always that simple. And without an intimate knowledge and/or experience with the clinical research industry, it can prove challenging to identify and place clinical research professionals with the right skill sets. As a result, sometimes it's better to go to a small or mid-size clinical staffing organization. They will often have ongoing, repeat relationships with clinical research professionals with years of experience and outstanding reputations in the field. And because they specialize in clinical research, they know how to ask the right questions and further qualify candidates in order to find the right individual or team of clinical research professionals your clinical trial requires.
So when loyalty and commitment are nice-to-have's, but specific therapeutic and clinical research industry experience is a must, try reaching out to a clinical staffing organization. You may never look at clinical staffing the same again.
Unless you've been under a rock, you've no doubt heard about the recent Avandia debacle.
GlaxoSmithKline (GSK), a London-based biopharmaceutical company with US headquarters in Research Triangle Park NC, makes the diabetes drug Avandia, which has come under increased scrutiny recently following rising concerns over its safety profile. Safety concerns over Avandia first arose in 2007 when a New England Journal of Medicine study linked Avandia to a 43% increase in heart attacks. GSK was forced to place a warning label on the drug, slashing its annual sales revenues by two-thirds.
Last week, GSK found itself in front of a federal advisory panel yet again. Though the advisory panel recommended the drug stay on the market, the recommendation is hardly a major victory for GSK. While GSK would consider any ruling better than recall, the drug's market share will face further erosion with additional label warnings concerning cardiovascular risks being requested by the panel.
In a recent News & Observer article "Avandia inquiry is rooted in Triangle," GSK defended Avandia saying the data from its safety study, RECORD, showed that "'Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death" when compared to other diabetes drugs. Quintiles, one of the world's largest global contract research organizations, has also become ensnared in the controversy. Based in the Research Triangle Park area as well, Quintiles managed GSK's RECORD safety study of Avandia.
While the FDA weighs the advise and recommendations provided by the advisory panel last week, they requested a partial clinical research hold this week of GSK's post-marketing cardiovascular study of Avandia known as TIDE. Comparing the cardiovascular safety of Avandia with Actos, Takeda's competing diabetes drug, the FDA said that patients who are already enrolled in TIDE can continue, but no new patients can be enrolled at this time.
Do you think the FDA will recall Avandia? If yes, what kind of impact do you think a recall will have on current clinical research guidelines and practices?
Do you think the FDA is increasing its oversight of clinical research, contract research organizations and the biopharmaceutical industry?
Trio attended ExL Pharma's Effective Business Development for Clinical Trial Service Providers in Arlington, VA earlier this week. This was ExL Pharma's 2nd year hosting the event. John Kreger of William Blair & Company gave his State of the Industry address in which he provided a historical view of the clinical research industry’s financial performance. This included an interesting take on the industry’s stages of evolution, from very tactical and transactional relationships, to today’s more strategic deals. John also included his thoughts on CROs that were “break out performers” at each stage in the industry’s evolution.
Our overall assessment? Well, we estimate about 80 attendees in all. Yes, small compared to some of the industry's larger conferences, but for the first time in a while, we were energized by the quality those attendees, including many high level decision-makers. Let's face it. Year after year, our love-hate relationship with the same large conferences continues. You know…the conferences we love to hate. But we keep going….we keep spending….and, yes, we keep complaining. Perhaps not any longer though given what appears to be a viable alternative.
ExL Pharma's event brought buyers and sellers together in an intimate, collaborative and educational setting. Rather than being held hostage in an exhibit booth, Business Development professionals were engaged in the sessions and were able to hear first-hand what clinical research decision makers are looking for in an outsourcing provider and strategic partner.
So do we plan to attend again? You bet. And we also plan to pursue more smaller, high-quality clinical research conferences like this one reflecting our newly refined tradeshow strategy.
We'd like to hear from you.
Did you attend ExL Pharma's Effective BD for Clinical Trial Service Providers? Did you find the conference beneficial? Why or why not?
What other smaller, yet high-quality conferences have you discovered in the clinical research industry?
If you're in the drug development / clinical research industry, you've probably heard by now that the recent Patient Protection and Affordable Care Act legislation passed by the US Congress included a provision called the Therapeutic Discovery Tax Credit which allocates a total of $1 billion in funding to small biotechnology companies with 250 or fewer employees. Companies qualify for a tax credit or grant equal to 50 percent of eligible R&D expenditures during the 2009 and 2010 tax years. A $5 million maximum exists per company.
The qualifying window is tight, so biotechnology and medical device companies need to move quick. Applications were made available June 21 and are due back to the Department of Treasury and Health and Human Services by July 21. Applicants will be notified of the grant and credit awards by letter no later than October 29.
Washington Editor Donna Young recently interviewed Fred Dorey with Palo Alto, CA-based Cooley LLP. In her article, Mr. Dorey said that a survey conducted last month by his law firm found "90 percent of respondents [biotechnology and medical device companies] indicated they intend to complete an application in hopes of obtaining some of the program's available funds or tax credits." Additionally, "64 percent said their submissions would be for projects involving therapeutics, while 27 percent said their applications were for device or combined device-drug projects. Only 9 percent involved diagnostics." The Cooley survey further found "47 percent of the projects seeking the grants and tax credits are preclinical while 34 percent were Phase I and Phase II projects. Just under one-fifth said their projects were Phase III or beyond."
According to the legislation, the primary objective of the Tax Credits will be to fund therapeutic discovery projects that will:
(1) result in new therapies to (a) treat areas of unmet medical need or (b) prevent, detect, or treat chronic or acute diseases and conditions;
(2) reduce long-term health care costs in the US; or
(3) cure cancer within the next 30 years
Additionally, the new Tax Credit aims to create and sustain high-paying jobs in the US and ensure that the US remains competitive in the life, biological and medical science fields.
As a biotechnology company meeting the outlined criteria:
- Do you plan to submit an application for the Therapeutic Discovery Tax Credit?
- Are you looking to fund Phase I, II or III clinical research for a therapeutic, medical device or diagnostic?
Trio attended DIA's 46th Annual Meeting at the Walter E. Washington Convention Center in Washington, D.C., June 13-17th. Although the temperatures soared outside, the weather wasn't the only hot topic at this year's conference.
While the DIA hosted a great networking event Sunday evening at the Newseum, a 250,000 square-foot museum on Pennsylvania avenue, this year's event didn't officially kick-off until Monday morning with a keynote address from US Food and Drug Administration Commissioner Dr. Margaret Hamburg.
While the DIA offered it's usual sessions, the themes and hot topics at this year's conference included:
- impact of healthcare reform on clinical research, e.g., personalized medicine, comparative effectiveness, increased regulatory stringency, innovation
- adaptive trials
- recent FDA warning letters
- constrained resources
- optimization of site/Sponsor/CRO relationships
- recruitment and retention
DIA 2011will be in Chicago and chaired by CISCRP Chairman and Tufts Center for the Study of Drug Development Senior Research Fellow Kenneth Getz, MBA. At the MAGI East conference earlier this year, Kenneth cited that the success of the future clinical research enterprise will depend on the industry's ability to optimize in the following three areas: protocol design; site relationships; and CRO relationships.
Do you agree with Kenneth's assessment? It will be interesting to see if Kenneth asserts at next year's DIA meeting that the same three areas of optimization are still essential to the future of the clinical research enterprise.
Did you know June is Vision Research month?
According to EyeCare America, the foundation of the American Academy of Ophthalmology, one in three Americans suffer from some kind of vision impairment by age 65. Many Americans are not aware that they have vision loss because there are either no warning signs or because they assume it's just apart of aging. Did you know that many cases of vision loss and even blindness are preventable? Check out these stats from EyeCare America:
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Glaucoma - more than 3 million Americans have glaucoma but over half don't realize it since there are often no warning signals. Glaucoma is the primary cause of blindness among African Americans.
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Diabetic retinopathy - diabetes is the leading cause of blindness among adults. Diabetics are 25 times more likely to become blind than those without it. Twenty-four million Americans suffer from diabetes; nearly 25% of them don't know it.
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Age-related macular degeneration (AMD) - leading cause of blindness in Americans 65 years or older. According to the National Eye Institute (NEI), more than 10 million Americans suffer from AMD.
So what should you do?
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Get regular eye exams by a board-certified ophthalmologist, including routine dilation and examination of the retina, the back of the eye.
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If you suffer from an eye disease condition, consider participating in a clinical study trial. Be sure to talk to your health care provider about whether a clinical study is right for you.
Check out the following two clinical study trial listings for ophthalmology studies.
NIH Clinical Research Studies
Clinical study trials being conducted at the National Institutes of Health Clinical Center in Bethesda, MD. You can also contact the NIH Patient Recruitment and Public Liaison Office at 1-800-411-1222 for assistance.
ClinicalTrials.gov
Listing of federally and privately supported clinical study trials conducted in the US and globally.
Trio is advancing the cause for site-saving treatments by supporting the biopharmaceutical industry in the conduct of ophthalmology clinical research, primarily in age-related macular degeneration.