Advarra’s Support for Institutions
As clinical research sites face more challenges than perhaps ever before, it’s increasingly important to provide sites with proper support to ensure smooth and efficient research processes. In particular, many institutional and academic sites are dealing with limited research staffing resources, sub-optimal research workflows, competing organizational priorities, and pressure from researchers and sponsors to maintain momentum and capacity for conducting trials.
Institutional sites are critical to successful clinical research and the advancement of healthcare as a whole. That’s why at Advarra, everything we do is driven by site centricity. The concept of site centricity involves investing in and centering support and workflows at the site level. This improves the outcome for all research stakeholders as well as participants, significantly impacting the research community at large. How does Advarra play a role in the movement toward site centricity?
At Advarra, our mission is to advance clinical research: safer, smarter, faster. This mission is embodied in everything we do, starting with our experienced staff, many of whom come from esteemed institutions and organizations within the clinical research community. With their vast knowledge and experiences, they have firsthand understanding of the issues and concerns important to institutions, because they’ve been in your shoes. Their passion is using their experiences to help institutions like yours optimize research and maintain compliance.
The variety of backgrounds Advarra staff bring to their current roles also provides useful and unique perspectives: they’ve seen why and how certain approaches are successful while others fail. In working with these experts, your organization leverages valuable context to find the best possible solutions and see maximum results.
Institutional Review Board (IRB)
With over 3,500 institutions supported by Advarra’s IRB capabilities, we’ve observed challenges and helped implement successes across all types of organizations, including:
- Academic medical centers
- Cancer centers
- Health systems
- Commercial sites
- Federal agencies
- Contract research organizations (CROs)
- Large pharma
- Emerging biotechs
Advarra’s central IRB provides dedicated, responsive service and expertise to support any research study. We understand the nuances and unique requirements of institutional sites, and we work with each institution to ensure local context is properly addressed and compliance is achieved at every level, from local to federal.
Our dedicated review staff can support your site’s clinical research at every phase, from early phase and first-in-human all the way to Phase IV and post-marketing research. Our IRB members represent clinicians, researchers, scientists, nurses, and others with direct knowledge of the conditions, standards of care, and patient populations under investigation. Our reviewers are also familiar with the latest in research technology, like eConsent, wearables, and mobile medical apps. Their educated perspectives help ensure reviews are informed, thorough, and of the same high quality you’d expect from your local IRB.
With multiple daily IRB meetings Monday through Friday, and technology-enabled processes designed to increase efficiency and allow staff to focus on the regulations and client needs, we can provide timely reviews that help make your institution become more competitive and appealing to sponsors.
Institutional Biosafety Committee (IBC)
With the recent boom in research involving genetically modified material, IBC review is suddenly at the forefront of many research professionals’ minds. Many institutions have local IBCs, but they primarily focus on preclinical and non-clinical projects, with less experience or expertise in the clinical space. Advarra can provide additional support for these local IBCs, in addition to serving as IBC for sites who don’t already have one onsite.
As a central IBC, Advarra can provide sites and institutions with a centralized biosafety review at significant speed and efficiency while complying with practices outlined in the National Institutes of Health (NIH) Guidelines. Advarra’s IBC meets regularly—essentially whenever a new site is ready for review—and provides a free NIH registration service to help speed startup for gene therapy trials. A faster IBC review enables sites to move forward with their studies at a quicker rate.
Advarra also offers the Gene Therapy Ready site network for sites interested in promoting their status as “gene therapy ready.” The Gene Therapy Ready site network is a comprehensive collective of clinical research sites ready to conduct clinical trials involving genetically engineered vaccines, gene-modified cellular therapies, and gene therapy research. Sponsors can save significant time during study startup by identifying sites already prepared to conduct this specialized research.
It’s more important than ever to enable sites to adopt and utilize their own technology across all trials, which can reduce duplicative data entry, enhance compliance, and allow site staff to focus more time on participants. Our technology solutions serve research sites of all types, from academic medical centers, cancer centers, health systems, and site networks, to individual research sites, helping sites manage their research more efficiently and enabling data-driven decision making. Developed with guidance from sites like yours, our site-centric ecosystem of technology solutions enables key workflows and integrations, improving compliance and further reducing time spent entering data.
In addition to the solutions themselves, we’re proud to support our technology customers through our Onsemble Community, a robust network of the nation’s leading clinical research professionals sharing best practices and addressing current challenges. The Onsemble Community allows researchers and research administration professionals to collaborate with colleagues while shaping the industry and the technologies they use every day. By working together, we can all move clinical research forward.
When an outside perspective is needed, Advarra Consulting’s Institutional Research Center of Excellence (CoE) is here to help. Empowering the clinical research community to achieve excellence, this group assists sites in complying with federal regulations, state and local law, and industry best practices. We work to maximize research activity efficiencies as we support institutions via process improvement, innovative technologies, and education.
Consulting services are as unique as the clients we serve; we understand your challenges and partner to deliver customized solutions to fit your unique needs. For example, we can identify seasoned professionals for short- and long-term staffing support, use industry best practices to assist in modernizing research policies and processes, help prepare for a regulatory audit, and so much more.
More than industry experts, Advarra consultants are former executives and practitioners, professionals with deep experience and a relentless focus for continuous improvement. We know what it takes to build the infrastructure to establish, administer and evolve compliant research programs. And we stand ready to help you deliver.
In addition to Consulting, Advarra’s Professional Services helps sites increase their research productivity while experiencing breakthrough efficiencies. We provide services including budget negotiation, informed consent development, coverage analysis, custom eLearning and more. Advarra knows time is of the essence and working with our experts to perform these tasks frees up your staff’s time, empowering them to focus on tasks that matter the most.
Advarra knows sites are at the heart of clinical research, and we are working to make sure we can assist in every aspect as you work to address and overcome things including staffing challenges, increased workloads, and accelerated activation timeframes. From our technology to our reviews and services, site centricity is at the core of what we do. Engage with us today to learn more about how together we can advance clinical research to be safer, smarter, and faster.