Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.
The Value of Clinical Research
Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients’ access to treatment options, improve patient care and outcomes, and transform the healthcare landscape. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy. Without clinical research, these medical breakthroughs would remain out of reach for patients. Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Advarra ensures that clinical trials comply with the U.S. Food and Drug Administration’s (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki.
Protecting Trial Participants
Trial participants are courageous volunteers, and every step must be taken to ensure their rights and welfare are protected. That is not to say that they do not face potential risks. This is why IRBs are tasked with conducting an ethical review of clinical trial proposals to ensure participants are informed of risks before and during their participation in any trial.
Advarra prides itself on not only providing ethical review services but also performing this critical work in a manner that fulfills regulatory requirements. For example, Advarra’s IRB is composed of approximately 200 experts, including scientists with diverse and extensive therapeutic area expertise, allowing for specialized and highly knowledgeable reviews, as well as non-scientists such as legal experts, ethicists, and members with expertise in vulnerable populations offering a different perspective than members with scientific/medical backgrounds.
Expertise and Experience
Advarra’s value to clinical research is driven by its team of dedicated professionals and collaborations with highly qualified research experts. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations. This includes researchers, ethicists, and compliance professionals with decades of experience, many of whom have worked with prominent institutions and top academic medical centers. The team also receives ongoing training and professional development to stay at the top of current clinical research practices.
Furthermore, Advarra’s IRB includes hundreds of expert members, many of whom bring expertise and experience in several therapeutic areas and disciplines, including oncology, bioethics, investigational pharmacy, internal medicine, psychology, physiology, radiology, public health, pediatrics, nursing, and social and behavioral science. Many individuals that belong to Advarra’s extended network of experts are active or recently retired clinicians from academic and large network clinical and hospital entities such as Harvard University, Mayo Clinic, Vanderbilt University, and several National Institutes of Health designated Comprehensive Care Centers.
This unique depth of expertise allows Advarra to maintain the highest standards in clinical trial reviews.
Industry-Leading Ethical Standards
Advarra is organized and operates in compliance with U.S. and Canadian regulations and policies governing research with human subjects, as applicable, and is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Advarra’s commitment to quality and ethical conduct is apparent in our internal policies and operational procedures, which often exceed federal regulations and set a benchmark for the industry. One such area that has always remained a focus for Advarra is our commitment to a robust set of policies that govern potential conflicts of interest.
Moreover, Advarra separates client services and IRB review teams to guarantee each clinical trial we review is unbiased. This firewall ensures that clinical trial reviews focus solely on ethics and scientific integrity.
Investing in Improvements
At Advarra, we understand that to maintain our position as a trusted partner to the clinical trials ecosystem, we need to invest in our people, processes, and technology. While other companies in the clinical trial industry are reducing staff and investments in technology, Advarra is committed to fostering continued innovation. One significant investment in this area is the Center for IRB Intelligence (CIRBI) platform, which streamlines the review process, improving the speed and quality of clinical trial evaluations. Over $25 million has been invested in this platform to enhance the effectiveness of the IRB process without compromising its thoroughness. Advarra has continuously hired additional staff to manage the increasing workload, demonstrating our commitment to continuous improvement and ensuring our standards align with Advarra’s best-in-class practices.
Looking to the Future
Advarra’s work benefits clinical trial participants and the entire healthcare ecosystem. By ensuring clinical trials are ethical and are held to rigorous standards of scientific integrity, Advarra helps advance the development of new therapies and treatments. Advarra’s commitment to quality, transparency, and continuous improvement sets a high standard for clinical research, ultimately advancing medical science and improving patient outcomes worldwide.