This article first appeared in DIA Global

The clinical trial ecosystem has become increasingly complex, with the number of drugs in development nearly doubling between 2012 and 2022. This growth, coupled with rising patient recruitment demands and the need for diverse trial endpoints, has highlighted the limitations of the traditional site model.

For decades, clinical trials have relied on a fragmented system of investigator sites and Principal Investigators (PIs). While this model was sufficient for smaller, less complex trials, it is no longer adequate to meet the demands of today’s research landscape. Nearly 80% of trials fail to meet enrollment targets and timelines, resulting in significant financial and operational challenges for Sponsors and CROs. According to Tufts University, delays in clinical trials cost Sponsors an estimated $540,000 in revenue per day, making inefficiencies a costly barrier to progress.

The Association of Multisite Research Corporations (AMRC) is a newly established trade association dedicated to advancing the use of multisite clinical research corporations (MCRCs) in the clinical trial ecosystem.

With a mission to transform the clinical research landscape, AMRC serves as a unifying voice for MCRCs, addressing systemic inefficiencies that have long plagued the traditional site selection model. By championing standardization, scalability, and operational efficiency, AMRC seeks to elevate the quality and speed of clinical trials, benefiting all stakeholders involved.

The Case for Change

AMRC’s vision is to create a future where MCRCs are widely recognized and leveraged by Sponsors, CROs, regulators, and policymakers for their ability to streamline processes, enhance data quality, and deliver innovative therapies faster. Its governance model emphasizes collaboration and inclusivity, bringing together key stakeholders to define and implement best practices for the industry.

AMRC was created to address critical challenges that hinder the effectiveness of clinical trials. These include operational inefficiencies, fragmented data systems, and the excessive administrative burdens placed on PIs and site staff. High rates of burnout among clinical personnel further exacerbate these issues, with many PIs opting out of research after participating in a single trial.

The rationale for AMRC’s existence lies in its ability to provide scalable, systematic solutions that modernize clinical trials and meet the growing demands of the industry.

AMRC has the potential to drive a shift in the clinical trial process. At launch, it represents nearly 400 sites and 1000 PIs, giving it the scale to define and advocate for industry-wide best practices that can accelerate the development of novel therapies, benefiting CROs, Sponsors, and patients.

AMRC’s Scale and Benefits

The association is funded through its membership base, which includes 14 founding multisite organizations representing nearly 400 sites, 980 principal investigators, and 7000 staff globally. AMRC’s members collectively enrolled nearly 85,000 patients in clinical trials in 2024 alone, underscoring their significant impact on the research ecosystem. This funding model ensures that AMRC remains independent while focusing on initiatives that benefit the broader industry.

AMRC benefits multiple stakeholders:

• Sites and Principal Investigators: MCRCs provide systematic training, operational infrastructure, and administrative support, reducing the burden on PIs and site staff. This approach mitigates burnout, improves retention, and enhances the overall quality of trial conduct.
• Sponsors and CROs: Centralized operations and streamlined processes simplify site selection, contracting, and trial management. By reducing startup times and improving data quality, MCRCs align with regulatory expectations and deliver value to Sponsors and CROs, first in the US and eventually scaled globally to regions including Europe, Canada, and Asia.
• Patients and Public Health: By accelerating the development of therapies and improving trial accessibility, MCRCs contribute to better patient outcomes and public health advancements. Their ability to enroll diverse patient populations ensures that trial results are more representative and applicable to real-world settings.

Success for AMRC means transforming the clinical trial ecosystem to make it more efficient, cost-effective, and patient-focused. Key indicators of AMRC success include increased adoption of MCRCs, faster trial timelines, higher enrollment rates, and improved retention of PIs. AMRC will measure its impact through metrics such as membership growth, member satisfaction, and the implementation of standardized practices across the industry.

Addressing Industry Challenges

To realize its vision, AMRC has outlined a comprehensive roadmap that prioritizes collaboration, education, and advocacy. The association’s immediate focus is on establishing industry standards, engaging key stakeholders, and building value for its members. These efforts will lay the foundation for a more efficient and effective global clinical trial ecosystem.

• Establishing Standards: AMRC is committed to defining unified training, operational, and technological standards for MCRCs. By partnering with industry stakeholders, including IRBs, other associations, and data providers, AMRC aims to conduct research that highlights the economic and patient impact of inefficiencies in the traditional trial model. This research will serve as a foundation for advocating for industry-wide adoption of best practices.
• Engaging Sponsors and CROs: A key priority for AMRC is to educate Sponsors and CROs about the unique benefits of MCRCs. Through targeted outreach campaigns, the association will showcase the advantages of centralized operations, standardized contracts, and enhanced data quality. Case studies highlighting the ROI of MCRCs will be developed to demonstrate their value and impact on trial outcomes.
• Building Member Value: AMRC aims to create a community where members can collaborate, share best practices, and access resources that enhance their operations. By facilitating connections with Sponsors and CROs, AMRC will help members expand their reach and increase their impact within the industry. Educational events, webinars, and content will be key components of this effort, ensuring that members stay informed and engaged.
• Driving Industry Transformation: Over the longer term, AMRC seeks to establish itself as a global authority on clinical trial excellence. The association will advocate for policies that promote the adoption of MCRCs, initially in the US and eventually internationally. By collaborating with regulators and policymakers, AMRC will ensure that its initiatives align with broader industry goals and priorities.

What’s Next?

AMRC’s launch marks the beginning of a transformative journey for the clinical trial industry. Its immediate next steps include hosting a series of webinar discussions. The association will also be launching research in short order to understand better the operational inefficiencies in the clinical trials landscape and what that costs Sponsors, CROs, and patients.

Over time, the AMRC aims to expand its membership, engage with new stakeholders, and drive meaningful improvements in trial efficiency, quality, and outcomes.

Readers of Global Forum can play an active role in supporting AMRC’s mission. By engaging with the association on social media, sharing AMRC’s news, and collaborating with founding members (listed on AMRC’s website), stakeholders can contribute to a more efficient and effective clinical trial ecosystem.

Together, we can build a future where clinical trials deliver life-saving treatments to patients more quickly, safely, and efficiently.