
Clinical trial sites operate at the intersection of science, ethics, business, and patient care. While the primary mission is to protect participant safety and generate high-quality data to accelerate the development of new treatments and medicines, long-term success depends on more than scientific rigour alone.

Clinical Research Associates (CRAs) perform a key role at the interface between Sponsor and site in the conduct of clinical trials. They are the primary link between Sponsors, CROs, and clinical research sites, responsible for oversight of protocol compliance, data integrity, patient safety, and regulatory adherence. Despite the critical nature of this role, CRA capability is often inferred from job titles, years of experience, or completion of internal training programs. In a clinical research landscape that is becoming more complex and risk-driven, this approach is no longer sufficient. Accrediting CRAs should be a strategic priority for sponsors and CROs.

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.

Clinical research quality standards in Latin America have reached an important new milestone. The International Accrediting Organization for Clinical Research (IAOCR) is proud to announce that Hospital Internacional de Colombia – FCV has become the first clinical research site in Colombia to achieve GCSA Site Certification.

Following inspiring meetings with each of the four regional chapters (Americas, APAC, Europe, and EMA) we’re delighted to announce that the work of the IAOCR Clinical Research Global Best Practices Board (GBPB) is underway.

Sherwood Forest Hospitals has marked a major milestone for healthcare innovation with the opening of its new, purpose-built Clinical Research Facility (CRF) at King’s Mill Hospital. This dedicated space is designed to support rigorous clinical trials and research studies — enabling cutting-edge treatments to reach patients across Mid-Nottinghamshire.

With patient safety and data integrity being principal to clinical research, it goes without saying that all site units must focus on compliance with ICH-GCP. However, well-run clinical studies are underpinned by more than legal and regulatory compliance.

In the high-stakes environment of clinical research, patient retention in clinical trials is arguably the single most critical factor determining a study’s success. For those conducting clinical research in a public health setting and sites both within networks and site management organisations (SMOs), recruiting study participants and then maintaining the required enrollment rate is only half the battle; ensuring that those participants remain engaged and committed to the study right through to the final visit is the true measure of operational excellence.

In the complex and critical interface where clinical research and innovation meet patient care, an essential level of oversight and governance is fundamental to ensure the continued protection of patient safety, the integrity of all trial data, and ethical conduct of all research under the umbrella of ICH-GCP.