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

  • How Oncology Research Is Advancing Better Research

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

  • Clinical Trial Budget Negotiations: A View From Each Side

    A key component to the success of a clinical trial is opening a site for recruitment, which requires accelerated startup times. Delays in budget negotiations and site startups can dramatically alter these timelines. This blog explores the impact budget negotiations has on study startup.

  • IRB Review Of Virtual Trial Technologies

    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.

  • Accelerating The Recovery – Design And IRB Review Of Safety Monitoring Plans During COVID-19

    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.

  • Vendor Qualification Vs Requalification Audits: What’s The Difference?

    - 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.

  • 12 Items Auditors Look For When Reviewing An Investigator Site File

    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.

  • Patient Engagement And The IRB

    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.

  • For Sponsors And Sites, The Research Restart Effort Begins With Communication

    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

  • Trial Design In The Time Of COVID-19: Complex And Efficient

    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 Calls Research Sites ‘Unsung Heroes’ Of COVID-19 Crisis

    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.

  • Virtual Symposium: Gene Therapy Research In The Age Of COVID-19

    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.

  • Study Activation: A Complex Process That Doesn’t Have To Be Painful

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

  • Protocol Feasibility To Promote Trial Efficiency

    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® Partners With Advarra To Expedite Virtual Trial Research For COVID-19

    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.

  • Advarra Joins Leading Healthcare Companies To Announce COVID-19 Research Database

    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 Acquires IRBco

    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.

  • How Sites Can Prepare For COVID-19 Genetically Engineered Vaccine Studies

    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 Announces 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 standards-based research technology solutions announced today the appointment of Gadi Saarony as Chief Executive Officer.

  • Advarra Technology Keeps Research Moving During COVID-19 Pandemic At Academic Institutions

    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.

  • How Research Informs The COVID-19 Response

    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.

  • Centralized IBC Review Benefits On Research

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

  • Are “Virtual Trials” Mainstream Yet?

    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!”

  • The Power Of Integrated Research Administration

    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.

  • Comparative Analysis For Non-IND Sites

    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.

     

  • Special Considerations For Pediatric Trials

    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

    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.

  • Tips For Submitting Expedited Review Studies

    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.

  • The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research

    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.

  • Botanical Medicines In 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.

  • Free Research Compliance Resources During COVID-19 Crisis

    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.

  • Key Biosafety Considerations For Coronavirus Research

    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.

  • IRB Review Of Coronavirus And Other Emerging Infectious Disease Research: Issues To Consider

    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.

  • Reporting To The IRB: What NOT To Report

    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.

  • Revised Common Rule Compliance Now In Full Effect—And What That Means

    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!

  • What Level Of Review Does Your Study Need?

    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.

  • Informed Consent: 6 Approaches To Increase Clinical Trials Participant Comprehension

    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.

  • 10 Tips For Writing Compliant Clinical Trial Participant Materials

    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.