ABOUT ADVARRA

Advarra optimizes compliance and clinical trials as the premier provider of global research compliance services, including IRB, IBC, consulting, and research technology products. Clinical trial sponsors and CROs recognize Advarra as the largest integrated provider of IRB services with the greatest institutional reach among health systems, cancer centers, academic medical centers, and investigators. Forte, now part of Advarra, is the industry’s leading provider of standards-based research technology, including OnCore CTMS. For more information on Advarra’s robust regulatory expertise and innovative products and services, visit advarra.com.

CONTACT INFORMATION

Advarra

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

UNITED STATES

Phone: 410.884.2900

FEATURED ARTICLES

  • Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.

  • With over 100 sites in the Academic and Community Center Research United (ACCRU) research network, utilizing a central IRB office was essential to increase review consistency and turnaround times.

  • Maintaining efficient, effective regulatory management processes can be a significant challenge. At Inova Health System, the research team improved regulatory efficiency by 20% without the need for extra regulatory staff by adopting Advarra’s eRegulatory Management System.

  • Does your organization utilize your in-house reporting teams and systems to their full potential? Learn how a standardized business intelligence system could complement your current reporting structure to improve your organization’s operations.

  • Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and the Common Rule have made it clear that the federal agencies favor centralized review by a single IRB for multicenter research. Download this guide to find out about issues your institution should consider as the research community evolves into the new landscape of mandated centralized IRB review.

  • Fiction often shows warp speed travels not going as planned, but what does warp speed mean for vaccine development in clinical research? Compared to the processes of 20 years ago, development of the current SARS-CoV-2 vaccine candidates has been remarkably swift thanks to genetic engineering and the additional resources afforded via Operation Warp Speed. Is this new approach used to develop COVID-19 vaccines safe?

  • Messenger RNA (mRNA) has made recent headlines due to its role in Operation Warp Speed. This article explores how its technology is used to fight the COVID-19 pandemic.

  • FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures Act (“Cures Act”), which was passed in 2016. In this blog we discuss what has and has not changed regarding CoCs and how this new guidance impacts research sponsors, research sites, and institutional review boards (IRBs).

  • Advarra, the market leader in regulatory review solutions and clinical site technologies, is pleased to announce the acquisition of YourEncore, a leading provider of drug development and commercialization advisory and consulting services to the biopharmaceutical industry.

  • We are honored to support a resilient research community during the COVID-19 pandemic. See the data points in our video to find out how Advarra helps keep research moving forward.

  • Advarra, the market leader in regulatory review solutions and clinical site technologies, is pleased to announce the acquisition of Longboat, an innovative provider of clinical trial technologies focused on site training, protocol compliance, and patient engagement

  • On October 23, 2020, the US Department of Health and Human Services Office of the General Counsel (HHS OGC) issued two important Advisory Opinions, 20-03 and 20-04, about the Public Readiness and Emergency Preparedness (PREP) Act and the HHS Secretary’s March 10, 2020, Declaration under the PREP Act for medical countermeasures against COVID-19.

  • Edit checks are a great mechanism to improve data quality within an electronic data capture (EDC) system. Here are a few tips to keep in mind when writing edit checks in eCRFs.

  • When an investigator has an idea for a study they’d like to conduct, they may begin what is known as an investigator-initiated trial, or IIT. This article provides a basic understanding of IITs and how they fit into the clinical research landscape.

  • Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), quality and compliance consulting services, and research technology solutions is pleased to announce the acquisition of IntegReview IRB, an AAHRPP-accredited central IRB.

  • There are many challenges involved in developing and negotiating a clinical trial budget that applies Medicare’s rules and regulations for device and drug clinical trials. In Advarra’s blog, we’ll discuss these challenges and suggest strategies to assist with this process.

  • The COVID-19 pandemic challenged the clinical research industry. This new urgency has affirmed certain clinical trial innovations originally pioneered in the oncology space.

  • Study startup timelines are a key factor in the ultimate success of a clinical trial. This blog explores the impact of budget negotiations on study startup from the perspectives of both sites and sponsors.

  • As virtual trial technology usage increases, the regulations governing IRB criteria for research approval and the underlying ethical considerations will not change. Explore key issues IRBs face when reviewing research that includes virtual trial technology this blog.

  • How do remote visits and remote data collection impact participant safety monitoring? This article presents ways to satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world.

  • - When supporting vendor qualification and management programs, there are different audits to consider. This article defines the differences and how to identify potential risks for your program.

  • Maintaining complete, compliant documentation on top of managing the complex processes and interactions of clinical trial conduct can be challenging. Advarra presents 12 items to help you prepare your ISF for an audit.

  • Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. Find out how IRBs and other stakeholders can assess potential issues and encourage patient involvement.

  • As the COVID-19 public health restrictions ease, it’s time to plan the restart phase for research activities. Find out how the “new normal” will impact research plans to re-open research after the pandemic

  • Are platform and adaptive trials the same? How can they improve research in the time of COVID-19? This blog post answers these questions and reflects on their features and benefits.

  • Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), research technology solutions, and quality and compliance consulting services, recognizes research sites as heroes of the COVID-19 crisis on Clinical Trials Day.

  • Gene therapy research continues its rapid expansion in the clinical setting, with 2019 marking an all-time high number of investigational new drug (IND) applications for gene therapy products. Read more on Advarra’s upcoming symposium.

  • Long activation timelines are a familiar concept in the clinical trial landscape. How can your site improve its study activation timelines?

  • Protocol feasibility review examines logistical aspects of a clinical trial prior to starting the activation process, helping studies meet their goal of accruing subjects at the site level. Read about how a protocol feasibility process can increase the probability of a successful clinical trial.

  • Science 37, the industry leader in decentralized clinical trials, and Advarra, a leading institutional review board (IRB), have partnered to expedite approvals on COVID-19–related virtual trials.

  • A consortium of leading healthcare companies today announced the launch of the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified and limited patient-level data sets made available to public health and policy researchers to extract insights to help combat the COVID-19 pandemic.

  • Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), research technology solutions, and quality and compliance consulting services is pleased to announce the acquisition of IRB Company, Inc. (IRBco), an AAHRPP-accredited central IRB that has conducted research reviews in the U.S. since 1981.

  • The global pandemic caused by the coronavirus (SARS-CoV-2) and the disease it causes (COVID-19) has brought vaccine research to the forefront. Currently available genetic engineering techniques and the available SARS-CoV-2 genome sequence provide a wealth of opportunities for research and development of new vaccines.

  • Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), research quality and compliance consulting services, and standards-based research technology solutions announced today the appointment of Gadi Saarony as Chief Executive Officer.

  • Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), research quality and compliance consulting services, and technology, today shared progress made by customers utilizing the company’s products and services to keep research moving forward during the COVID-19 pandemic.

  • Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors. Let’s look at information we are hearing from the current coronavirus (COVID-19) pandemic to highlight how research informs our daily lives.

  • Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research.

  • Have you heard the latest media buzz? Apparently, all clinical trials are going “virtual.” If the articles and buzz are correct, researchers “need to prepare now for this new reality!”

  • Read a “Tale of Two Health Systems,” one with a centralized research administration and one without. A story we’re sharing in case it helps others in the research community.

  • A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
    coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

     

  • Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

  • Managing conflicts of interest in clinical research is a critical mission for many reasons.Here we discuss the need for conflict of interest policies, examine the role of an IRB in managing conflicts of interest, and review key elements an IRB’s policy should include.

  • Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.

  • As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

  • Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

  • Advarra announces the availability of free resources to support and enable the clinical research community and ongoing research during the coronavirus disease (COVID-19) crisis. This includes complimentary transfer of IRB oversight, access to a new version of Forte eRegulatory management software, eReg Lite, and a dedicated “Ask Advarra” resource for rapid guidance on emerging issues impacted by COVID-19.

  • New and emerging infectious diseases like coronavirus are a fact of life, but the reaction of the research community can impact how far they spread. Learn how biosafety measures help advance vaccine development in our recent blog article.

  • For emerging infectious disease research, efficient and high-quality IRB review is critical. Find out about special IRB considerations for emerging infectious disease research based on Advarra’s experience reviewing the majority of current US coronavirus research.

  • Learn what NOT to report to your IRB from an IRB operations expert. Many of the "potential" unanticipated event reports IRBs receive don't pertain to IRB responsibilities, and such submissions provide no regulatory or legal coverage.

  • How does the revised Common Rule affect your research? On January 20, 2020, we reached the final compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”). Get the facts here!

  • The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.

  • Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.

  • Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles of participant protection, allowing participants to make informed decisions about what is in their own best interest, with the materials that appear at the earliest stages of recruitment as well as through the life of the study. Well-informed prospective and current participants lead to improved recruitment and retention rates.