
ABOUT ADVARRA
Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted IRB and IBC review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Advarra is advancing clinical trials to make them safer, smarter, and faster. For more information, visit advarra.com.
BROCHURES
- IRB Services For Institutional Sites
- Compliance Without Compromise
- Advarra University And Training
- Advarra Consulting: Global Consulting Powered By Relevant Experience
- Mitigate Risk With Research Billing Compliance Services
- Cosmetics Research And IRB Review
- Advarra eReg Integrations Overview
- Clinical Research Staffing Solutions
- Support For Institutions
- Advarra Custom Learning Portals
- eConsent Overview
- Elevate Your Research With Comprehensive Tools And Expertise
- Streamline Your Regulatory Process
- Study Startup Support
- Quality Center Of Excellence
- SiteIQ
- Optimize Your Research Administration, Compliance, And Operations
- Custom eLearning Services
- Pandemic Response Assessment
- Virtual Investigator Meetings By Advarra
- Advarra Regulatory Consulting
- Institutional Biosafety Committee (IBC) Reviews
- IBC And Consulting Services
- Advarra eRegulatory Management System Overview
- Advarra Electronic Data Capture (EDC) System Overview
- Budget Setup Services
- Budget Negotiation Services
- Coverage Analysis Services Info Sheet
- Site Performance Metrics And Feasibility Support
- Study Activation Consulting
- GxP Auditing, Compliance, & Specialized Consulting Capabilities & Services
- Protocol Development & Medical Writing
VIDEOS
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Decentralized clinical trials and the solutions and services that support them are still taking shape in the new research landscape. Learn what they are, how they impact your responsibilities and explore solutions to challenges implementing decentralized clinical trials.
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In this video, learn why Advarra is trusted by global clinical leaders to enable safety, compliance, & efficiency in their research. Advarra advances human health, by making clinical research safer, smarter, and faster.
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An institutional biosafety committee (IBC) is a panel of experts that assesses risks associated with gene therapy research to ensure the research is conducted safely and in compliance with the NIH Guidelines. Watch this video to learn what an IBC is and when IBC review is required.
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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.
NEWS
- Advarra Launches Cloud-Based Secure Document Exchange To Accelerate Study Startup
- Advarra Acquires YourEncore, A Leading Provider Of Drug Development And Commercialization Advisory And Consulting Services
- Advarra Acquires Longboat, A Leading Provider Of Site Training, Protocol Compliance, And Patient Engagement Solutions
- HHS OGC Issues Important Advisory Opinions On The PREP Act
- Advarra Acquires IntegReview IRB
- Advarra Calls Research Sites ‘Unsung Heroes’ Of COVID-19 Crisis
- Science 37® Partners With Advarra To Expedite Virtual Trial Research For COVID-19
- Advarra Joins Leading Healthcare Companies To Announce COVID-19 Research Database
- Advarra Acquires IRBco
- Advarra Announces Appointment Of Gadi Saarony As Chief Executive Officer
- Advarra Technology Keeps Research Moving During COVID-19 Pandemic At Academic Institutions
- Free Research Compliance Resources During COVID-19 Crisis
CONTACT INFORMATION
Advarra
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
UNITED STATES
Phone: 410.884.2900
FEATURED ARTICLES
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Learn how a developed billing plan by performing MCA can help individual research sites and sponsors estimate their expenses on protocol-required items and services.
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Discover how more medical professionals are becoming familiar with this rare disease and how it’s helping to significantly impact lifespan rates.
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Ensure the protection of research participants, proper address of local requirements, and a competitive and productive research program with a single institutional review board (sIRB).
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Learn how clinical teams using a single institutional review board (sIRB) can oversee all trial sites in a multisite study.
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To ensure a seamless process, there are several factors to consider when adopting an eConsent platform. When launching the process, organizations should think about taking the steps outlined in this article before the first patient uses the new platform.
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Explore the challenges of defining and measuring “quality” IRB review and certain key efforts by research community stakeholders to overcome such obstacles.
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Discover how having all sites use a central IRB can build efficiencies and results in significant resource savings for everyone involved in the research study and improves human subject protections.
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Within the last few years particularly, read about the trends surrounding physical workplaces, technology, regulatory requirements, evolving site and sponsor relationships and more.
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Explore a step-by-step process to determine whether your clinical trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.
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To better understand what sIRB review requirements mean for sites and sponsors, it’s important to first understand what an single IRB is and how it works. Gain insight into a single IRB review in the U.S.
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Learn about the challenges of bringing rare disease drugs to market within the U.S. system and some of the guidance for sponsors on meeting them.
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The most recent Cancer Center Support Grant (CCSG) guidelines released by the National Cancer Institute (NCI) include a new Core component. Find out its purpose and how to grow diversity, equity, and inclusion programs.
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Although it’s becoming more widespread, explore why there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance.
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In this episode discusses patient-centric strategies and solutions of real research programs at CSL Behring to improve the patient experience and retention in clinical trials.
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An IIT is a result of an investigator creating an idea for a study, developing the protocol, and serving as both the sponsor and the investigator for the trial. Discover why there is much to plan in order for it to run smoothly.
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On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). This blog highlights some of the major proposed changes and how they may impact the clinical research community.
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Learn how the solution to the key challenge of successful, timely study startup requires careful coordination across multiple constituencies outside and within a research organization.
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According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective.
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Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress. Find out more in this blog.
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This blog highlights how IRBs can simplify review of electronic patient reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) materials to streamline study startup without impacting the review quality.
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Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research.
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Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring additional oversight by an institutional biosafety committee (IBC). So what’s the difference between an IBC and an IRB?
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This blog outlines essential strategies for identifying the appropriate sites, analyzing historical site performance and feasibility, and implementing better communication and tools across stakeholders.
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A top-30 pharmaceutical company was conducting two phase 3, multicentre, randomized, double-blind studies to evaluate the safety and efficacy of a treatment for a serious dermatological condition. So how did the sites involved manage such significant and prolonged engagement?
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This infographic outlines how the public learns about clinical trials, why they participate, and the enrollment challenges trials pose.
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Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. While Part 11 is widely known, this blog explains how it fits in with your research software.
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This white paper discusses the EAC’s role in research, the basics of setting up an EAC, and regulatory context on why it is so important for the committee to be completely separate from study conduct.
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A well-trained, effective, and efficient team is key to a successful clinical trial. This blog reviews the breakdown of types, goals, principles, and strategies for ensuring you have a trained and effective team.
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In 2009, the Food and Drug Administration (FDA) released a guidance document on adverse event (AE) reporting to IRBs. This blog examines what the regulations do and do not say about IRB reporting requirements, and addresses some of the undefined “gray areas.”
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Use this list of common elements included in research grant applications and budgets to ensure you’ve considered all the necessary resources in your proposal.
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This blog defines eConsent, offers considerations for conducting eConsent, and navigates communicating with your institutional review board (IRB) as you figure out how to include this process at your organization.
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Gain insight into the site selection process sponsors undergo and the information sites provide as part of site feasibility questionnaire completion.
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In this report, Advarra explores what the "next normal" will be for clinical research organizations following the COVID-19 pandemic.
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Explore how direct communication and integration between key operating systems contributes to a more efficient and compliant trial.
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Discover how Advarra is pushing to bring innovative approaches to the research community, starting with one of the costliest, most resource-consuming challenges facing research teams: zero and under-accruing protocols.
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Sites provide a wealth of data to sponsors and CROs throughout a study. But how much of that data is truly valuable? In this article, we explore the metrics sites need to measure in order to improve internal processes and become more attractive to sponsors and CROs in the future.
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In this blog, learn why it is important to encourage sites to seek buy-in from their sponsors as they advocate for using their preferred technology platforms on studies.
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In this blog, delve into a basic understanding of the EDC system and its role in clinical trials.
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This blog identifies applicable regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.
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Aside from being a regulatory and ethical requirement, discover why informed consent is a good way to ensure participant knowledge and start a relationship between researcher and participant.
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Discover why empirical research into participant views and experiences has consistently shown participants' desire to learn the results of research to which they’ve contributed.
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This article outlines common eReg management system integrations, and highlights a new integration already allowing sites to save hundreds or thousands of dollars per protocol.
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This blog looks at the key elements of a good charter and explores why these details are critically important to the successful completion of the research.
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Learn how an eLearning solution was used to help overburdened trainers from a large National Cancer Institute (NCI)-designated hospital system.
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Explore how a clinical research operations assessment was conducted to ensure compliance and maintain critical funding sources.
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Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.
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This eBook is designed to help prepare for an upcoming FDA inspection, outlining what to expect during the investigation, and strategies to employ as the investigation process comes to a close.
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Learn how clinical quality services, designed to enable compliance with critical good clinical practice requirements, were used to assess and mitigate study startup risks, and identify key issues and concerns in clinical operations and clinical trial management process areas.
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Comprehensive pre-screening is overlooked in favor of more familiar, but also more outdated, manual tactics. In this blog, learn why that’s a mistake and why pre-screening is the great missed opportunity for modern day trial enrollment.
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The Whole Product Approach: An Integrated Approach To Evaluating And Selecting Enterprise Technology
This eBook will outline the general principles of the Whole Product Approach for selecting systems supporting clinical research operations and will illustrate how the Whole Product Approach is adopted to help research sites implement, utilize, and extract maximum value from site technology.
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Most institutional review board (IRB) inspections and audits focus on common elements. This blog aims to provide an overview of such items to help you understand the standards to which IRBs are measured against.
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Discover how a large clinical research site network was able to accomplish fast and compliant informed consent form (ICF) writing that helped meet sponsor clients’ expectations with the help of an outside source.
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In this blog, take a closer look at what significant risk (SR) and nonsignificant risk (NSR) determinations mean for medical device clinical trials.
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Learn why who sponsors a decentralized trial study and how the study is funded are key drivers for determining the trial’s regulatory oversight framework, as well as the framework used by the IRB.
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Find out how incidental findings can result from a standard, approved clinical test or intervention and can also be found from a research test or intervention.
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Curious about mRNA technology and the regulatory requirements for its use in clinical trials? Read on for answers to the most commonly asked questions.
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Learn why a pre-IND meeting is crucial to addressing questions related to the initial clinical study design, as well as answering other important questions potentially affecting the IND application.
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Most organizations understand the importance of creating a competitive advantage with a targeted, aggressive hiring strategy – but why is this typically exclusively focused on external candidates? Find out in the available blog.
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In this blog, discover an approach to building an agile workforce while becoming resilient to change and developing an innovative mindset ready to futurize the industry.
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This blog outlines five considerations when selecting an eIRB system for your organization.
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Discover how a top 10 biopharmaceutical company expanded its regulatory efficiency and automated key workflows between their IRB Platform and their electronic master file (eTMF).
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This white paper discusses the data safety monitoring board's (DSMB) role in research, the basics of setting up a DSMB, and why independence is so important.
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Explore why organizational leaders must understand the key factors redefining CDOs and the steps they must implement to drive value in the short term, as well as address the critical need to drive greater efficiencies amidst an industry-wide war for clinical research talent.
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While there are clear benefits to understanding which technology sites are relying on most, read this article to delve deeper into identifying opportunities for sites in the months and years ahead.
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There’s no question about it: clinical research sites are stretched thin. In this article, understand current struggles sites are facing from study startup through closeout.
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In the fast-paced clinical research industry, time is of the essence. Discover why knowing the benefits of using eSource, tips for implementing eSource, and maintaining compliance in your eSource solution may make all the difference in an efficient trial.
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Learn how remote and hybrid working models have shaped current regulatory trends, and what it suggests moving forward.
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Watch to learn the reasons why research sites, site networks, health systems, academic medical centers, and cancer centers use a CTMS to centralize information related to protocols, subjects, staff, financials and billing, and much more.
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Accrual is the ultimate outcome of success for a clinical trial. Gain insight into how without accrual, data cannot be obtained to answer the scientific objective being investigated.
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What does digital acceleration mean for clinical research, a traditionally risk-averse industry? Find out in the available blog.
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Informed consent is one of the central protections the regulations provide to research participants. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs).
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This blog outlines five benefits of engaging with an expert partner for biopharmaceutical and medical technology companies.
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Recently, Advarra conducted an anonymous survey to collect site-specific study activation data to help understand how sponsors can enable faster study activation at sites. Explore the top four takeaways.
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This white paper will explore four strategies to execute across site selection, training, ethics review, and site initiation.
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Research sites that rely on a local IRB typically take at least twice as long to activate than sites that rely on the study’s single central IRB. Utilizing the central IRB not only helps to streamline study startup but also enables increased efficiencies in managing sites throughout the study’s lifecycle.
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Reasonably, it takes a village to conduct a clinical trial. And among the many vital contributors to successful clinical research in the U.S. is the institutional review board (IRB) – sometimes known as an independent ethics committee (IEC), an ethical review board (ERB), or a research ethics board (REB).
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What are the differences between working with a local IRB and working with a central one? Find out in this blog post.
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What’s the difference between an EAC and a DMC? This blog outlines the requirements for each committee, what they do, and the critical roles each plays in keeping research participants safe and in advancing clinical research.
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While artificial intelligence and machine learning are not new concepts in science, in the last decade the clinical research community has seen tremendous growth in these areas. But what do “artificial intelligence” and “machine learning” really mean?
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This white paper focuses on key issues of interest to sponsors who may be interested in planning and designing EFIC studies, sites and investigators conducting EFIC research, and IRBs charged with reviewing EFIC studies.
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This article includes considerations for designing your next EFIC (exception from informed consent) research project and covers key questions to ask when reviewing EFIC research.
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In this blog, learn about the changes and implications from the updated European Union (EU) pharmaceutical legislation for the Clinical Trials Regulation.
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In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one nonprofit set out to fill this critical gap for hospitals across the U.S. Find out how they moved through the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) filing process in this blog.
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Learn how an audit report should identify how quality and risk management are managed throughout the entirety of the study conduct.
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Learn how a growing biotech company worked to develop a nitric oxide and delivery device for babies in the newborn intensive care units (NICU).
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This blog provides a beginner’s overview of clinical trial billing compliance and best practices to ensure charges and claims are properly routed to the correct billing entity.
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Explore how an integrated approach to the clinical research industry’s technology landscape can remove friction, improve access, save time, and better serve patients.
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Due to their high volume of research across industry and investigator-initiated studies, discover the solution the site staff at Duke University uncovered regarding the impact of inefficient processes on an exponential level.
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The days of using spreadsheets to track are thankfully over for most sites. Discover how a clinical trial management system (CTMS) can be configured to the needs of research centers and can bring powerful efficiencies insights, and compliance to their day-to-day operations.
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This eBook examines how a clinical trial management system (CTMS) addresses several challenges to managing a clinical trial.
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Learn how BYOT will benefit all research stakeholders from sites to participants, making safer, smarter, and faster clinical trials a reality.
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This white paper outlines IRB reporting requirements, providing clarity on why IRB reporting is important, what should and should not be reported, and the problems of under- and over-reporting.
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Despite their potential impact on a study’s success, training programs are often outdated, unengaging, and redundant. Therefore, it is critical to select a vendor or program encompassing not only regulatory requirements but also your organization’s goals.
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Find out how identifying, implementing, and adopting ongoing GDPR compliance initiatives without disruptive impacts to current Eurozone customers was achieved in this case study.
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This paper focuses on how to ensure the clinical plan is feasible, focuses on the issues that matter, and mitigates anticipated risk to the program.
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For an early-stage pharma/biotech company, the Clinical Development Plan (CDP) can be extremely valuable and a key indicator of potential success of a program. This white paper highlights key components for developing and executing a clinical research strategy once the plan is in place.
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Learn more about how the clinical trial associate (CTA) role could be the key to aligning organizational design and business imperatives, as well as focus on innovation and agility in the clinical trial management industry.
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The COVID-19 pandemic highlighted the need for organizations conducting research to have certain protocols in place, including robust emergency preparedness plans. Designed to guide communications and operations throughout an ongoing public health emergency, it’s important an organization has an emergency preparedness plan in place.
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In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one nonprofit set out to fill this critical gap for hospitals across the U.S. However, they needed guidance as they moved through the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) filing process.
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This eBook addresses common challenges sites and sponsors encounter when collaborating on a clinical trial and provides proactive best practices to help resolve these challenges.