FEATURED ARTICLES

• A Beginner’s Guide To Medicare Coverage Analysis

  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.

• Sickle Cell Disease: The Importance Of Amplifying Patient Voices

  Discover how more medical professionals are becoming familiar with this rare disease and how it’s helping to significantly impact lifespan rates.

• Tips For Working With A Single IRB For The First Time

  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).

• sIRB Oversight For Multisite Research

  Learn how clinical teams using a single institutional review board (sIRB) can oversee all trial sites in a multisite study.

• Developing And Implementing A Successful eConsent Process

  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.

• What Is A Quality IRB Review?

  Explore the challenges of defining and measuring “quality” IRB review and certain key efforts by research community stakeholders to overcome such obstacles.

• A Toolkit For Sponsors And CROs Shifting Institutional Sites To Central IRB

  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.

• 2023 Trends Impacting Clinical Research

  Within the last few years particularly, read about the trends surrounding physical workplaces, technology, regulatory requirements, evolving site and sponsor relationships and more.

• The Workflow Of Medicare Coverage Analysis

  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.

• Beginner’s Guide To Single IRB Mandates

  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.

• Rare And Orphan Diseases: Choosing A Path To Regulatory Approval And Market Success

  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.

• Diversity In Cancer Research: Getting Started

  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.

• Regulatory And Ethical Considerations For eConsent In Research

  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.

• Patient Centricity In Clinical Research

  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.

• Setting Yourself Up For Success During Investigator-Initiated Trials

  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.

• FDA’s September 2022 NPRMs: What They Mean For Academia And Industry

  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.  

• A Checklist For Optimizing Clinical Trial Study Startup Activities

  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.

• How Paper And Electronic Source Data Meet ALCOA-C Principles

  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. 

• Keys To Unblocking The Innovation Bottleneck In Research

  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.

• Unpacking IRB Innovations For Decentralized Clinical Trials

  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.

• How Centralized IBC Review Can Benefit Gene Therapy 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. 

• IBC Vs. IRB: What’s The Difference?

  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? 

• Strategies For Successful Site Selection In Clinical Trials

  This blog outlines essential strategies for identifying the appropriate sites, analyzing historical site performance and feasibility, and implementing better communication and tools across stakeholders.

• Demonstrating The Impact Of The Longboat Portal On Recruitment Success

  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?

• Patient Recruitment And Enrollment In Clinical Trials

  This infographic outlines how the public learns about clinical trials, why they participate, and the enrollment challenges trials pose.

• Beginner’s Guide To 21 CFR Part 11 Compliance

  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.

• What Does An Endpoint Adjudication Committee (EAC) Do?

  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.

• Scale Your Training Program: Three Successful Models

  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.

• Reporting To The IRB: Serious Adverse Events (SAEs) In Drug Studies

  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.”

• Grant Application Checklist

  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.

• Enhancing Research Conduct Using eConsent

  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.

• Current State Of Trial Opportunity And Selection

  Gain insight into the site selection process sponsors undergo and the information sites provide as part of site feasibility questionnaire completion.

• The Future Of Work In Clinical Research

  In this report, Advarra explores what the "next normal" will be for clinical research organizations following the COVID-19 pandemic. 

• Utilizing eRegulatory Integrations To Expedite Regulatory Workflows

  Explore how direct communication and integration between key operating systems contributes to a more efficient and compliant trial. 

• Insights Accrual Prediction Platform Leverages Machine Learning To Advance Better Research

  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.

• Site-Driven Metrics: Operational Data To Improve Research

  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.

• Addressing Research Technology Challenges To Gain Sponsor Buy-in

  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.

• The Beginner’s Guide To An Electronic Data Capture (EDC) System

  In this blog, delve into a basic understanding of the EDC system and its role in clinical trials.

• Beginner’s Guide To eTMF, eISF, And Regulatory Research Documents

  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.

• Informed Consent: When, Why, And How It’s Obtained

  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.

• Return Of Research Results To Study Participants

  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.

• The ROI Of eRegulatory And eIRB Integration

  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.

• What Goes Into A Charter For DSMB Or Endpoint Adjudication?

  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.

• Large NCI-Designated Hospital System Trains 400 End Users, Resulting In Increased Levels Of Efficiency And Consistency

  Learn how an eLearning solution was used to help overburdened trainers from a large National Cancer Institute (NCI)-designated hospital system.

• Large Research Healthcare System Maintains Compliance Through Internal Program Assessment

  Explore how a clinical research operations assessment was conducted to ensure compliance and maintain critical funding sources.

• Developing An Organizational Roadmap For Post Authorization Safety Studies

  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.

• Complete Guide To FDA Inspection Readiness

  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.

• Delivering Clinical Trial Management Oversight

  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.

• Best Practices In Pre-Screening Includes Use Of Technology

  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.

• 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.

• Common Elements Of IRB Assessments

  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.

• Large Clinical Research Site Network Streamlines Study Startup With Reliable, Timely ICF Writing Services

  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.

• Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations

  In this blog, take a closer look at what significant risk (SR) and nonsignificant risk (NSR) determinations mean for medical device clinical trials.

• Why Do Funding And Legal Structure Matter In Decentralized Clinical Trials?

  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.

• What Do I Do About Incidental Findings In Research?

  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.

• mRNA Clinical Trials: Key Regulatory Considerations

  Curious about mRNA technology and the regulatory requirements for its use in clinical trials? Read on for answers to the most commonly asked questions.

• Beginner’s Guide To Pre-IND Meetings

  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.

• Building An Agile Workforce In Clinical Research

  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.

• Clinical Trial Associates And The Future Of Pharma

  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.

• 5 Considerations For Evaluating An eIRB System

  This blog outlines five considerations when selecting an eIRB system for your organization.

• Top 10 Biopharma Achieves Significant Regulatory Efficiency

  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).

• Establishing And Operating A DSMB

  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.

• Organizational Design For Clinical Development Organizations

  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.

• Technology Trends: The Top 3 Opportunities For Sites In 2022

  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.

• Research Site Perspectives On Sponsor-Provided Technology

  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.

• Considerations For Transitioning From Paper To eSource

  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.

• eClinical Regulatory Trends Impacting Clinical Research

  Learn how remote and hybrid working models have shaped current regulatory trends, and what it suggests moving forward.

• Clinical Trial Management System

  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.

• Case Studies In Accrual Prediction

  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.

• The Impact Of Digital Transformation In Clinical Trials

  What does digital acceleration mean for clinical research, a traditionally risk-averse industry? Find out in the available blog.

• Informed Consent Writing

  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). 

• Study Startup Success For BioPharma And MedTech: Engage A Research Compliance Partner

  This blog outlines five benefits of engaging with an expert partner for biopharmaceutical and medical technology companies.

• Study Activation: Top Four Takeaways From Research Sites

  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. 

• Expedite Study Startup: Four Strategies To Optimize Site Activation

  This white paper will explore four strategies to execute across site selection, training, ethics review, and site initiation. 

• Global CRO Drives Study Startup Efficiency By Converting Local IRB Sites To Central IRB Review

  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. 

• Beginner’s Guide To Institutional Review Boards

  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).

• Local Versus Central IRBs: What’s The Difference?

  What are the differences between working with a local IRB and working with a central one? Find out in this blog post.

• DMC Vs EAC: What’s the Difference?

  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.

• Considerations For IRB Review: Artificial Intelligence And Machine Learning

  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?

• Planned Emergency Research And Exception From Informed Consent

  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.

• Planned Emergency Research

  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. 

• Understanding The EU Clinical Trials Regulations Updates

  In this blog, learn about the changes and implications from the updated European Union (EU) pharmaceutical legislation for the Clinical Trials Regulation. 

• Navigating The FDA Emergency Use Filing Process

  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.

• Critical Steps For Writing An Impactful Clinical Audit Report

  Learn how an audit report should identify how quality and risk management are managed throughout the entirety of the study conduct.

• Keys To Advancing Your Biotech Go-To-Market Plan

  Learn how a growing biotech company worked to develop a nitric oxide and delivery device for babies in the newborn intensive care units (NICU).

• Beginner’s Guide To Clinical Trial Billing Compliance

  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.

• The Rise Of The Clinical Research Network: Using Technology To Connect Sites And Sponsors

  Explore how an integrated approach to the clinical research industry’s technology landscape can remove friction, improve access, save time, and better serve patients.

• Prioritizing eReg Site-Centric Workflows Within A Connected Research Ecosystem

  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.

• Beginner’s Guide To Clinical Trial Management Systems

  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.

• Driving Site Efficiency And Visibility With A CTMS

  This eBook examines how a clinical trial management system (CTMS) addresses several challenges to managing a clinical trial. 

• It’s Time For Sites To “Bring Your Own Technology” (BYOT)

  Learn how BYOT will benefit all research stakeholders from sites to participants, making safer, smarter, and faster clinical trials a reality.

• Reporting To The IRB: What Does And Does Not Need To Be Reported

  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.

• The Clinical Research Training Program Checklist: What To Look For

  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.

• GDPR Implementation Support

  Find out how identifying, implementing, and adopting ongoing GDPR compliance initiatives without disruptive impacts to current Eurozone customers was achieved in this case study.

   
• The Clinical Development Plan: Executing the Clinical Strategy

  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.

• The Clinical Development Plan: Ensuring Success

  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.

• The Future Of Clinical Staff Development Planning

  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.

   
• Developing An Emergency Preparedness Plan For Your HRPP

  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.

• Navigating The FDA Emergency Use Filing Process

  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.

• Improving Site-Sponsor Relationships: Efficient Strategies For Transparent Clinical Trials

  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.