For many small to medium-sized investigative sites, the scramble to find clinical study opportunities continues to intensify. Some sites have become part of informal networks that help find available studies for individual members, while others turn to middlemen or trial management firms, often called study brokers, who are available to assist investigative sites in boosting their business development and lead-generation efforts.
While study brokers have been in operation for more than two decades, their business model has changed substantially from simply finding studies and charging hefty up-front fees to offering a wide range of support services including forecasting and budgeting, centralized study start-up assistance, media buying and recruitment promotion, lead generation and business development, general marketing and operations consulting. Study brokers pride themselves on having first-rate connections to sponsors and CROs that enable them to know about upcoming studies before individual sites learn about those opportunities.
Some professionals have more of a mixed view of intermediaries. “The dynamics of the study broker model has changed in recent years, but I don’t think any site would see study brokers as their primary business development activity,” said Christine Pierre, R.N., founder and CEO of the Society for Clinical Research Sites (SCRS). “Sites that use brokers usually engage them to augment their business development. And when sponsors and CROs have to choose between networks and study brokers for finding sites, there is a greater degree of comfort with the network.”
In this feature, CenterWatch focuses in detail on four select study brokers to understand and characterize the variety of models and approaches offered to investigative sites. It’s important to note at the outset that none of the following organizations charge sponsors or CROs fees for their services.
Midwest Clinical Support Inc.
Launched in 1995 and considered one of the oldest study brokers, Midwest Clinical Support Inc. has grown from 150 sites in 2000 to 301 independent sites in 11 therapeutic groups today.
Unlike PharmaSeek and ClinEdge, which provide a range of startup and financial services support in addition to lead generation, Midwest Clinical focuses solely on lead generation matched to the capabilities of its network of independent sites. The accumulated information on each site’s capabilities and performance is why its members win the majority of the trials it pursues from sponsors and CROs, according to Dan Ulrey, Midwest Clinical Support’s CEO and founder.
“We’ve accumulated a lot of information over the last 20 years to where we can forecast future performance. We have performance metrics on each site—a virtual capability that makes a difference for sponsors when reviewing our sites for their studies,” said Ulrey. “What matters most is the enrollment and retention study timelines for the pharmaceutical companies”
Ulrey explained that Midwest Clinical prequalifies the protocol and matches it to the site(s) in the network. Typically, Midwest Clinical contacts its site or sites after the protocol has been prequalified, and asks the site to decide if it wants to conduct the study. Once the site and sponsor agree, the investigative site pays a nonrefundable fee to Midwest Clinical based on the study budget and the number of completed patients requested by the sponsor.
Sites seeking entry into the network contact Midwest Clinical knowing that there are strict entry criteria including years of clinical trial experience, infrastructure and past performance success. Ulrey said only one out of 10 sites that seek entry into the independent network succeeds.
“Often the sites seeking entry don’t have the right capabilities; their coordinators and some of their principal investigators either lack experience or are just trying to enter clinical research and look for study brokers to provide them with studies,” said Ulrey. “It takes a good three to five years from inception and the completion of 10 to 15 studies to develop the infrastructure to be good candidates for our network. So we define site quality as solid performance; a good track record in the completion of clinical trials; good infrastructure; highly talented coordinators with administrative experience and familiarity with technology. We also reject a fair number of protocols we receive from sponsors because the design criteria are too stringent or are not feasible.”
As for competition in the study broker arena, Ulrey said he only knows of several firms in the market, but noted that those that do their homework and provide value-added services to sponsors, CROs and sites will prevail.
PharmaSeek—which works with 240 sites and 1,300 PIs—offers a range of startup services including budgeting, contracting, receivables management and patient recruitment assistance, without any long-term or exclusive agreements. PharmaSeek is only compensated if the site successfully enrolls patients. Typically, a portion of each study grant payment is earmarked for PharmaSeek.
PharmaSeek’s goal is to link clinical studies together with experienced, high-performing and independently owned research sites. The 21-year-old company works with sponsors and CROs to streamline the site identification and study startup process, which includes centralizing administrative and business functions.
“We find study opportunities, negotiate budgets/contracts, and provide other value-added services. Because we only get paid if a site enrolls patients, our interests are aligned with the sites, sponsors and CROs,” said Nicolas Cindric, CEO of Middleton, Wis.-based PharmaSeek.
“We are also seeing an uptick in industry-funded research from academic medical centers, as government-funded research is constrained and reimbursements continue to get squeezed,” said Cindric.
PharmaSeek, Cindric noted, turns over about 4% to 6% of the sites in its network, replacing lower-performing sites with those that it expects will do better. Prior to adding a site to the network, the company uses a six-step evaluation process that includes background and referral checks, reviews of historical performance (notably recruitment and quality), and an assessment of the site’s key personnel (coordinators and PIs).
“We have heard from other brokers, but we chose PharmaSeek because they can cast a very wide net to find studies for us,” said Trish Hardee, president of Riverside Clinical Research, which has been part of PharmaSeek’s network for more than 12 years. “They have helped us make connections with CROs and small biotechs, where if you do a good job, these companies come back directly to us. We also like working with PharmaSeek because you are only obligated for studies you choose, which for us is better than the ClinEdge model where you pay monthly even if you don’t always get studies that match your needs.”
Investigator Location Services
Investigator Location Services (ILS), provides basic services matching experienced clinical investigators with specific sponsor and CRO studies. Formed 14 years ago in Bend, Ore., it bills itself as the largest study broker in the U.S., with a database of 27,000 investigators.
Since 2001, ILS has recruited more than 9,750 experienced clinical investigators for 407 sponsors and CROs on more than 960 protocols, according to Joe A. Bollert, Ph.D., company founder and president, a 40-year veteran of the drug development industry.
“It’s a simple business, which is a free service to sponsors and CROs, as only the individual investigators pay our broker fees, which range from $2,000 to $9,000, per study and only if a study is placed,” said Bollert.
“We speed-up investigator recruiting, where for example we get an email about a nephrology study and email 484 nephrologists in our database with a brief description that does not reveal the name of the sponsor, but does provide inclusion/exclusion criteria, the number of patients and trial recruitment length, and the approximate size of the grant for the completed study. If a nephrology investigator is interested, we send his credentials to the sponsor or CRO and both sides agree to do the study, our role is finished. If both sides cannot agree or the combination of sponsor and investigator is not a good fit, there is no fee for us.”
Investigators who use ILS find there is no fee if the sponsor comes back to the site/investigator directly with future business. Clinical research sites can leverage broker contacts with sponsors and CROs, paying ILS only for the first study, which gives the clinical research site an opportunity to perform, noted Bollert. He added that good performance should produce other new study opportunities without a broker fee. Also, the company does not remove inactive investigators or track how many studies he or she conducts.
Boston-based ClinEdge works with 36 geographically dispersed and independently owned sites. Each has been conducting clinical research for at least 13 years and about 90% of the sites have been with the company for at least five years, according to ClinEdge CEO Christian Burns. The company also works with 250 investigators in the U.S. and Canada. Each investigator conducts 20 trials annually, Burns noted.
ClinEdge employs relationship managers who work with pharma companies or CROs on site studies and other managers who run the sites directly. Both oversee day-to-day operations.
“We strive to increase productivity, innovation and revenue of our clients through personalized services and a profound understanding of the clinical research industry,” said Burns. “We streamline the startup process with pharmas and CROs, where they have one ClinEdge person to deal with across all our sites. If they see our sites are struggling with recruitment for any reason, we can boost enrollment. We have a full media team that can come in and implement any service to maximize site resources to be more successful. We’ll put together an average of 120 study leads per month. So if you had a pain study, and we have eight pain sites, we gather the information, talk to each of the eight doctors about it and make a rational decision and whether we can do it fairly quickly.”
Segal Institute for Clinical Research worked with ClinEdge initially for its psychiatric studies and more recently for women’s health clinical research. With nine clinical study locations in South Florida and South Carolina, it turned to ClinEdge to find clinical trial grant leads and a more efficient way of handling its business development issues.
“They had the infrastructure and organization that we needed. Their flat monthly fee was less than hiring a full-time employee,” said Segal Institute Vice President Bonnie Segal. “We’ve used their marketing, patient recruitment, help with creating social media content for institutional review board submissions and they helped us launch a monthly newsletter and blogs—all of which gains us exposure on the Web to reach a young audience for our psychiatric trials. For us, the return on investment with ClinEdge has been excellent.”
ClinEdge also runs a second site network called Blue Theory Clinical Trials with sites that are smaller in size, younger and less experienced. They are supported at the consulting level to help make their site research infrastructure better. That includes standard operating procedures (SOPs) and quality assurance.
Some successful investigative sites maintain that study brokers are good in the beginning and for expanding into new medical areas where they lack experience, while others urge sites to ignore brokers and focus on developing relationships with pharmas and CROs.
“What prompted us to use ClinEdge was really the need to increase our pipeline. We weighed our options of whether to use them or hire a full-time employee dedicated to finding certain studies and augment our work with different sponsors,” said PMG Research Senior Director of Client Services Amanda Wright. “We continue to evaluate this decision, as study brokers will diversify their services.”
For Terry Stubbs, founder and CEO of ActivMed, relying on ClinEdge is more cost-effective than hiring a full-time person to find studies. “They have ‘feelers’ into the CRO/sponsor community and help us find the work we need to ‘stay alive’ much faster than we could ourselves,” said Stubbs. “I have used another study broker before and most of the trials offered to us were hard to recruit for and just looking to add on sites, which meant they were dogs and not the cream of the crop as clinical trials go.”
Some established sites view brokers as unnecessary middlemen who are only concerned about an income stream rather than a site’s success. “I have always avoided study brokers because I do not understand why a sponsor or CRO would use them as compared to going directly to the sites,” said Jeffrey Rosen, M.D., medical director at Clinical Research of South Florida. “Brokers act as a wedge between the sponsor/CRO and sites. I hear from brokers on a regular basis—and avoid them.”
Similarly, Terry Poling, M.D., medical director and founder of Heartland Associates and one of 16 members of the Alliance for Multispecialty Research views brokers as “another parasite and I stay completely away from them. But if I was starting a site today and having difficulty getting studies, I might consider a broker but soon go it alone without their help.”
Some experienced sites believe that study brokers perpetuate the availability of novice, less sophisticated sites for biopharmaceutical companies. “The brokers’ business model can be a hindrance to our industry because they contribute to an already highly fragmented, highly competitive sector of our industry which is already in financial crisis,” said Benchmark Research CEO Mark Lacy.
High-performing clinical investigators that have performed well with major biopharmaceutical companies may soon gain additional study grant opportunities from a competitor to study brokers—the Investigator Registry, a shared repository of investigator contact and operating details developed by TransCelerate and DrugDev. The registry claims to accelerate identification and recruitment of qualified investigators. TransCelerate has predicted that the new registry will lessen the burden on clinical trial sites to constantly update multiple records, and benefit participating TransCelerate member companies with reduced costs and improved time and efficiency of the entire clinical trial start up process.
To date, five of the 20 TransCelerate members have begun using the Investigator Registry—with three more members slated to join by the middle of this year—and all who sign up will be able to tap into a database of more than 300,000 investigators, according to Munther Baara, TransCelerate’s Investigator Registry lead. He declined to reveal the cost to members using the Investigator Registry.
“In 2016, this registry will take off,” said Baara, adding that investigators have to register or opt-in to the registry and provide information about the studies and companies they worked for, with TransCelerate members able to share information about individual investigators.
As for study brokers, Baara quipped, “There will always be a niche market for them.”
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 23, Issue 01, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>