The Alliance for Multispecialty Research (AMR), which includes some of the most experienced independent clinical research centers in the U.S., has established a new business model that fully integrates its 17-member network and better positions the organization to collaborate with sponsors and CROs in preferred provider site networks and strategic partnerships.

The new model, announced at the annual Drug Information Association (DIA) meeting, allows sponsors and CROs to engage multiple AMR sites using central budgeting and contracting processes and standardizes other practices, such as study source documentation and general standard operating procedures (SOPs), throughout the network to maximize economies of scale and consistency. Service offerings also include protocol feasibility assessments, an integrated team with a primary point of contact for each trial and identification of appropriate investigators for a study through the alliance’s central office.

“We are answering a need in the industry from sponsors and CROs to be fully integrated and to offer them faster, better service. They can identify sites quicker and get one contract, one budget and one set of source documents,” said Jeffrey B. Rosen, M.D., medical director of Clinical Research of South Florida and one of AMR’s founding members.

The alliance research centers, which have an average of 24 years of experience, individually are involved in preferred provider networks established by CROs and sponsors during the past few years. Yet the fact that these investigative sites work together through the AMR has been largely unknown.

“It’s to everybody’s benefit if we can introduce sponsors and CROs to our partner sites and if we can work as a group streamlining the processes,” said William B. Smith, M.D., president and principal investigator at Volunteer Research Group/New Orleans Center for Clinical Research and another AMR founding member.

As part of its stepped-up integration activities, the organization plans to increase its visibility in the industry and focus business development activities on establishing new preferred provider relationships between the AMR network and sponsors or CROs. Last year, the alliance formed a partnership with PRA Health Sciences to conduct vaccine studies, and the network has been involved in other collaborative initiatives.

“We want to be the group of choice for both CROs and sponsors. Our goal is to be involved with them very early on so we can work together on upcoming pipelines and prepare in advance for upcoming trials to help improve the entire development process,” said Rosen. “AMR is the same sites and the same quality. But now we are fully integrated.”

The alliance’s decision to fully integrate its network reflects how the investigative site landscape has begun to evolve, mature and consolidate in recent years. CROs, which increasingly manage site operations for sponsor companies, have bought investigative sites or established strategic partnerships with high-performing sites and site networks in order to improve efficiency and predictability in study conduct.

“The size of your site, or the size of your site network, matters,” said Christophe Berthoux, DMV, CEO of Synexus Clinical Research, which has 30 dedicated sites and 65 affiliates in 11 countries. “Bigger site groups will have a much greater financial stability, leverage in contract negotiations with sponsors and CROs and they will be able to provide more patients into particular trials, which is very important for both the industry and the patients. I foresee that the bigger sites or site groups will be even more prevalent in the future.”

The AMR was formed in 1994 by a group of investigators in response to an industry-wide move toward developing site management organizations (SMOs) and site networks. The AMR investigators aligned their sites, established central contracting processes and collaborated on joint marketing programs in order to compete with these new networks. But when the SMO concept failed to take off, the AMR sites largely continued to function independently. Over the years, however, the members have continued to conduct business development together, share best practices and study leads, support a central office and hold biannual meetings to discuss industry trends.

“That served us well,” said Smith. “But over the last couple of years, we have seen some large studies that we were interested in participating in being contracted in their entirety or their majority with site networks. That has not happened in a long time. In view of the push for these networks and their intrusion into our pipeline on a couple of occasions, we have re-evaluated the benefits of further integration.”

The new AMR model differs from some other integrated networks. It employs staff from individual sites with a particular expertise to manage that area for the group rather than adding additional infrastructure to the central office. In addition, the model allows sponsors and CROs the flexibility of working either with an individual alliance site or with multiple sites, depending on the organization’s needs.

“With the additional integration, we can function as one network, or when appropriate, we can function as separate entities. That flexibility sets us apart from some of the other integrated networks,” said Smith. “We can provide extensive central infrastructure or we can provide minimal central infrastructure, whatever the sponsor or CRO prefers. We are allowing for flexibility that emphasizes what the sponsor and CRO wants, not what fits into a pre-existing infrastructure.”

The alliance, which employs a rigorous peer review and acceptance process for new members, plans to expand its network within the next couple of years. Current members include Baptist Health Center for Clinical Research, Center for Pharmaceutical Research, Central Kentucky Research Associates, Clinical Physiology Associates, Clinical Research Associates, Clinical Research Associates of Tidewater, Clinical Research Consortium-Arizona, Clinical Research Consortium-Nevada, Clinical Research of South Florida, Coastal Clinical Research, Heartland Medical, Heartland Research Associates, Maine Research Associates, MediSphere Medical Research Center, Rochester Clinical Research, VRG/New Orleans Center for Clinical Research-Tennessee and VRG/New Orleans Center for Clinical Research-Louisiana.

“The trend of sponsors and CROs working with site networks and preferred sites seems to be accelerating, whether it’s a preferred site network that the sponsor or CRO is putting together or whether it’s a site network agreement. We think we will be able to be more competitive if we grow,” said Smith. 

This article was reprinted from Volume 20, Issue 28, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »