Defining and Demonstrating Quality in Multisite Clinical Research: The IAOCR Perspective

Quality in clinical research is a concept that everyone values, yet one that remains inconsistently defined and unevenly recognized across the industry. As multisite clinical research corporations (MCRCs) continue to expand their role in global trial delivery, there is a growing need for a clearer, more meaningful understanding of what “quality” truly looks like in practice.

In response to the USA-based, Association for Multisite Research Corporations (AMRC) consultation on defining and demonstrating quality in multisite networks, IAOCR, together with a global group of industry leaders, submitted a joint response grounded in real-world experience, evidence, and globally adopted best practice standards. This blog highlights the key themes from that response and explains why a more holistic approach to quality is essential for the future of clinical research.

The full response paper can be accessed here IAOCR Joint Response-AMRC Consultation

Why Quality Needs to Be Reframed

The consultation response acknowledges several important realities. Sponsors and CROs consistently value speed, consistency, and efficiency when working with clinical research sites. Despite this, operational excellence is still not widely recognized as a marker of quality. As a result, sites and site networks are often under-credited for the very attributes that enable reliable data, positive participant experiences, improved patient outcomes, and better client (CRO/sponsor) experiences.

IAOCR’s Role in Advancing Global Best Practice

IAOCR was established in 2011 to support the development, recognition, and assurance of quality across the clinical research industry worldwide. Today, IAOCR provides international accreditations and certifications to professionals and organizations in over 55 countries. All standards are developed collaboratively with the industry and are subject to continuous review to ensure alignment with evolving best practices.

IAOCR’s competency frameworks have been reviewed by the MHRA and shared with the FDA, and are now widely adopted by CROs, sponsors, sites, and membership organizations globally. These frameworks underpin many workforce development, training, accreditation and certification programs, providing a consistent and internationally recognized foundation for assessing competence and professionalism at individual and organizational levels.

Moving Beyond Checklists and Credentials

A key message from the joint response is that traditional indicators of quality, such as investigator experience, staff tenure, or training certificates, are not sufficient on their own. While these factors are important inputs, they do not reliably demonstrate competence or real-world performance.

Experience does not always equate to being fit for purpose. High staff retention does not guarantee high-quality delivery. Training records often show what content was delivered, but not the quality of that training or whether individuals can apply it effectively in practice. Over-reliance on these measures can place both patients and clinical research outcomes at risk.

True quality requires meaningful assessment of competence, supported by clear standards, robust evaluation processes, and independent oversight.

A Stakeholder-Centered Approach to Quality

IAOCR advocates for a broader definition of quality that reflects the experiences of all key stakeholders involved in clinical research. These include trial participants, employees, commercial clients, and suppliers. Quality should be evidenced through both quantitative and qualitative measures that demonstrate consistency, reliability, and trust across these groups.

This approach informed the development of the Global Certification Standard for Clinical Research Sites (GCSA), launched in 2023 following extensive global consultation with sponsors, CROs, government bodies, and sites. GCSA focuses on the business operational processes that underpin the successful delivery of clinical trials, ensuring a patient-centric experience while enabling effective collaboration across the research ecosystem.

Since its launch, GCSA has been adopted by sites of all sizes across the USA, Europe, South America, the Middle East, and APAC, providing independent assurance that organizations are operating to globally recognized quality standards.

Professionalism, Workforce Quality, and Culture

MCRCs are often recognized for efficiency, but professionalism is less frequently acknowledged. From an IAOCR perspective, professionalism is not about uniformity or box-ticking. It is about embedding values, behaviors, and expectations into the organizational DNA.

IAOCR’s Workforce Process Quality Certification (WPQC) supports organizations in assessing and improving workforce maturity across bronze, silver, and gold levels. This certification examines how organizations design roles, assess competence, support development, and embed values, helping to drive continuous improvement rather than one-off compliance exercises.

Robust competence evaluation is central to this approach. Organizations must understand the skills, knowledge, and behaviors required for each role and use this understanding to identify development needs and support targeted learning interventions.

Technology, Data, and Human Oversight

As AI becomes increasingly accessible across the industry – to organizations of all sizes, responsible implementation and governance will be key differentiators.

While technology can enhance efficiency and consistency, it should not be viewed as a standalone indicator of quality. Instead, quality depends on how technology outputs are validated, how consistency is assured, and what human oversight processes are in place.

Participant Experience as a Core Quality Indicator

Participant experience is a cornerstone of quality and a foundational element of the GCSA standard. While participant outcomes are influenced by many factors beyond a site’s control, MCRCs can demonstrate quality by evidencing how participant feedback is collected, analyzed, and used to drive continuous improvement.

Independent certification of operational processes, combined with demonstrable use of participant insights, provides a credible and transparent way to evidence patient-centered research at scale.

Looking Forward

The AMRC consultation provides an important opportunity for the industry to align around a more meaningful and evidence-based definition of quality. From IAOCR’s perspective, quality must move beyond perceptions and proxies, toward independently and globally recognized quality standards, delivered by accreditation experts and based on demonstrated competence, with consistently applied best practices.

By recognizing operational excellence, investing in workforce quality, and adopting globally recognized certifications and accreditations, MCRCs and clinical research organizations of all types can more clearly demonstrate the value they deliver to patients, sponsors, and the wider industry.

To explore how IAOCR consulting, training, accreditation or certification services can benefit your organization contact us.