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.

VIDEOS

  • 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.

  • 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.

  • 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.

CONTACT INFORMATION

Advarra

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

UNITED STATES

Phone: 410.884.2900

FEATURED ARTICLES

  • In this blog take a look at the specific role DMCs play in overseeing research, and how IRBs rely on the independent DMC’s oversight of interim trial data to ensure an adequate safety monitoring plan is in place.

  • This blog aims to provide a beginner’s overview to the regulatory concept of “minimal risk,” and which regulatory flexibilities research might be eligible for.

  • Phase I studies raise unique challenges, in both their design and implementation as well as for the institutional review board (IRB). Proactive strategies for identifying and addressing these challenges can enable ethical IRB review and timely study implementation.

  • A thorough asset review optimizes the potential for an asset to achieve an organization’s clinical, regulatory, commercial, and market access goals. This blog provides a beginners’ guide to understanding independent asset reviews (IAR) and their role in clinical research.

  • In a remote clinical research landscape, a successful virtual investigator meeting can ensure a more cost-effective and compliant clinical trial. This blog will expand on those critical elements and provide examples of how to implement them in your next study.

  • Implementing a clinical trial management system (CTMS) can generate significant improvements to the way your organization understands your research portfolio, manages the financial components of your trials, leverages reporting and analytics, and more.

  • As the clinical research industry becomes more technology-centric than ever before, it’s becoming more common to work with connected technology platforms to streamline studies. Read about working with integrated eSource, electronic patient-reported outcome (ePRO), and electronic data capture (EDC) systems.

  • This blog covers three must-have decentralized trial tools to efficiently and compliantly implement remote modalities at your organization.

  • Decentralized clinical trials are gaining popularity and momentum, promoting a more flexible participant experience as a whole. However, decentralized trial modalities also present unique challenges. Download the available white paper to find out more.

  • In this episode, Aidan Gannon of Advarra and Jessica Perry of Moderna discuss patient centricity in clinical research.

  • Read in the available blog how clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.

  • It’s no secret that in clinical research, everything moves at a quick pace – and that doesn’t stop when working with outside vendors. Institutional review board (IRB) partners are no exception. As a sponsor, how can you make the most of your relationship with your IRB?

  • Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. In this blog, we’ll explore how existing regulations might be applied to establish best practices in using social media for research participant recruitment and engagement.

  • In clinical research, utilizing your clinical trial management system (CTMS) to its fullest potential can allow for more streamlined financial management, visit management, compliance, patient recruitment, and more. This blog outlines what you should look for in a CTMS to maximize your organization’s return on investment (ROI).

  • Read in the available blog how rethinking how your site’s fiscal priorities have shifted–and the possible effects of these shifts on operations, sponsors, and participants–can help ensure your financial management leads to long-term business success.

  • At the core of clinical research, the safety of all stakeholders is paramount. This blog outlines IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance across your research program.

  • Clinical development proceeds in phases, and each phase contains a set of clinical trials. Below are some examples where considering ROI benefits individual study designs and the program overall.

  • Vendor management and oversight of clinical trials continues to be a critical activity for sponsor companies planning and conducting clinical trials. Read how vendor management and oversight is not only a regulatory imperative, it is also a business imperative.

  • In recent years, the gene therapy field has experienced booming growth. This white paper focuses on gene therapy uses in oncology and discusses operations and infrastructure at a cellular immunotherapy program at a National Cancer Institute (NCI)-designated comprehensive cancer center.

  • The development of new treatments, both drugs and biologics, is a long and arduous process, which can take many years. Read about the two major obstacles to getting approval and market authorization.

  • Depending on the level of decentralization of your trial, you need secure cloud-based technology to adhere to Good Clinical Practices (GCP) while overseeing, communicating, and managing the entire trial process. Read how the best tools are scalable to any level of enterprise complexity and help maintain study quality, while allowing you to adapt to any level of decentralization according to protocol.

  • Across the life science industry, many development companies and research and development (R&D) organizations do not have a quality department or even a specific quality function in their early stages of development. Read how science and research-driven activities require a high degree of flexibility and may demand fast reviews of development stages – at times, even reconsideration of the development program or project termination. 

  • Developing an investigational new drug (IND) application is a big milestone for organizations. Too often, though, the chemistry, manufacturing, and controls (CMC) aspect of the IND are not fully considered until it is too late, resulting in a delayed IND submission or even a clinical hold letter from the Food & Drug Administration (FDA). To understand more about how these roadblocks may impact an IND, this blog outlines three common CMC pitfalls.

  • While it may not have been common a few short years ago, cell and gene therapy’s popularity has grown exponentially in the past year, as researchers are rapidly expanding our understanding and potential uses of these innovative therapies. The possibilities with this new technology are exciting. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.

  • Increasing diversity and inclusion in research has long been a challenge in the clinical research community. This paper shares unique perspectives from industry experts regarding barriers and strategies for improving access to research for diverse and underserved populations with approaches ranging from grassroots community efforts to enterprise-wide initiatives spanning large research sites and CROs.

  • Data is the most important asset that a pharmaceutical or biotechnology company has, and the number and complexity of sources of data in clinical trials is increasing all the time; at the same time, there is increasing pressure to deliver high quality data with accelerated timelines. This white paper describes a standardized approach to developing a data strategy that can be customized to a company’s current needs and can be adjusted as those needs change.

  • 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.

  • Breaking down barriers to participation in clinical research has long been a challenge, affecting every aspect of the industry. This blog aims to define diversity, equity, and inclusion (DEI), discuss exclusive trends in recruitment and trial design, and present actionable steps sites can take immediately.

  • In a recent study activation survey we asked clinical research site professionals to examine the current state of study activation in the industry and identify the processes and resource constrains impacted. Here we have categorized five areas of protocol feasibility and identified items in each area indicating successful activation practices.

  • Billing compliance ensures all services in a trial are paid for, working to reduce double billing and preventing billing services not covered by the trial or are not medically necessary for the participant. This infographic explains how non-compliance can happen and how it can be costly to an organization.

  • The gene therapy market is accelerating at unprecedented speed, with expected growth globally of 16.6% between 2020-2027, but it hasn’t been an easy road. In this episode, Advarra’s Daniel Eisenman talks with Dr. Adam Soloff and Dr. Paul Gulig for an enriching discussion about the growth, misconceptions, and promise of gene therapy. 

  • Regardless of whether you are a sponsor or an investigative site, it is imperative that you have a reliable system and associated policies for storage and upkeep of documents surrounding trial conduct.

  • The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar from everyday life: “coercion” and “undue influence.” These concepts surface in IRB review of research involving vulnerable populations, where the regulations enjoin IRBs to apply additional safeguards for populations that “are likely to be vulnerable to coercion or undue influence.” Despite the regulatory importance of these concepts, there is wide variation in how they are understood and applied by IRBs in practice.

  • Historically, OHRP has said that the Common Rule reporting requirements apply to all nonexempt human subjects research covered by an FWA, regardless of funding source. In other words, institutions must follow the Common Rule reporting requirements for activities supported by a Common Rule department or agency, or for "check the box" research. Learn why it is critical for FWA-holding institutions to know whether the box is checked on their FWA and to understand what that means for research at their institution.

  • As the research industry is continually evolving and adapting, many institutions, health systems, and private research sites are adopting more electronic technologies to streamline operations. While oftentimes, sponsors or CROs provide sites with validated technology, many adopt these technologies themselves. For quality management professionals and site regulatory personnel in the position to evaluate a system’s effectiveness, quality, and compliance, they need to understand how Part 11 compliance fits into the quality management framework. Here we outline how sponsors should consider 21 CFR Part 11 (Part 11) compliance at research sites and how that fits in with the overall quality management system they may administer, build, audit, or evaluate.

  • 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.

  • Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide. Read how UWCCC was able to enhance their data analytics and visualization capabilities helping them improve operational oversight, especially through greater visibility into site accrual metrics.

  • The COVID-19 pandemic forced a CRO to reimagine what was possible as it became clear traditional timelines would not be sufficient to move the new COVID vaccines through clinical trials and to the public at warp speed. Working with Advarra, they were able accelerate review times so the COVID vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

  • Study activation processes take time, resources, and an upfront investment from your site. More time spent on study activation results in a lower chance of meeting financial and accrual targets. Five notable success factors from sites who have improved study activation are described detail in this paper. Learn how to streamline study activation and maximize operational efficiency.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.