GUEST COLUMNISTS

  • The Clinical Trials Transformation Initiative: Shaping The Future Of Clinical Research

    The Clinical Trials Transformation Initiative (CTTI), co-founded by Duke University and the FDA, consists of a group of individuals and organizations working to improve the quality and efficiency of clinical trials. This article shares CTTI's goals to improve clinical trials and modernize research, as well as how you can get involved.

  • Digital Solutions For Clinical Trials Aren't “One Size Fits All”

    Undoubtedly, digital trials will stay as the world coexists with the pandemic, so it is essential for both sponsors and sites to be early adopters. This article will examine the benefits and challenges of digital clinical trials and identify key considerations for sponsors and sites as the world continues to navigate the new normal.

  • How To Overcome The 3 Major Challenges In Conducting Rare Disease Clinical Trials

    Designing and conducting clinical trials for rare diseases often requires drug developers to plan for and address many challenges that are often not associated with or are less severe in larger trials for more common diseases and conditions. If they are not adequately addressed, these challenges can result in trial delays or discontinuations. This article shares Cyclo Therapeutics' 3 lessons learned.

  • Decentralized Clinical Trials: Data Considerations & Value-Added Taxes

    The rapidly changing regulatory, tax, and global business landscape, driven in part by COVID-19 and ongoing economic and political shifts, means that biopharma executives must keep careful watch over how they implement and monitor decentralized clinical trials (DCTs). This article examines key considerations for biopharma executives in overseeing hybrid or fully decentralized clinical trials.

  • Can Real-World Evidence Transform Healthcare? FDA Indicates Yes

    Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

  • Digital Vs. Decentralized Trials: What’s The Difference & How Do I Meet Implementation Challenges?

    Digital clinical trials, which have gained momentum since the onset of the pandemic, have the potential to address many of the inefficiencies of traditional trials. This article defines digital clinical trials and how they differ from decentralized clinical trials, as well as how to meet implementation challenges.

  • Our Lessons Learned In Implementing AI In Clinical Development

    Taiho Oncology had multiple sources of clinical data that weren't being leveraged to their fullest potential. When they implemented an AI-powered data analytics platform, they obtained a single source of truth for data analysis and reporting, and they learned a number of valuable process- and people-oriented lessons along the way.

  • Is A Decentralized Clinical Trial Right For Your Trial? & 5 Tips For Success

    Pharmaceutical companies have achieved considerable success in decentralizing clinical trials and shown that this model can offer significant benefits — both during the pandemic and afterward. While some elements of decentralization can be applied across all trial types, this article covers several specific trial characteristics that are particularly suited to remote studies, as well as tips to maximize success.

CLINICAL TRIAL WHITE PAPERS

  • Reducing Site Workload For Better, Faster, Safer Clinical Trials

    Life science companies are under increasing pressure to execute clinical trials faster with higher quality.  Read survey results that show as the Lunexis platform adoption increased, study teams began to see an improvement in data quality, operational efficiency, and ease of use compared to traditional paper and EDC methods.

  • The Secret Sauce In Successful Clinical Trial Payments Programs
    9/13/2021

    More than 80 percent of sites surveyed want to get paid in 30 days, and many clinical technology companies offer specialized software solutions to help manage several components of the site payments process. However, these systems still require a large effort by the sponsor to operate. What is the secret sauce for success?

  • Optimizing Immuno-Oncology Clinical Trials For Biotech Companies
    3/3/2021

    For biotech companies developing an immuno-oncology (IO) therapy, the complexity of oncology clinical trials takes on new dimensions. Review the current IO landscape and considerations for biotech companies preparing for IO studies.

     
  • Assembling The Right Team For A Successful Nonclinical Program
    11/18/2021

    Discover insight into the importance of – and requirements for – nonclinical studies and review recommendations for putting together a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.

  • From Chaos To Order In 3 Steps: The Guide To Planning Your TMF Migration
    1/27/2021

    Knowledge and planning are the keys to successful TMF migration. This guide from Phlexglobal is designed to help you navigate the most important part of any TMF migration: project scoping and planning. Once you have a firm grasp of the three key steps listed in this brief, you will find it much easier to manage a successful TMF migration – whether performed internally or outsourced to a provider.

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring
    9/8/2020

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • How Data Integration Saved Time And Increased Output
    10/27/2021

    An established biotechnology company needed a technology partner to support them in implementing risk-based quality management and providing greater visibility into their data. In this case study, learn a risk-based approach with data visualization and communication that dramatically increased output and time savings.

  • GrantPlan: Making Fair Market Value A Reality
    6/22/2020

    Building an accurate budget for a clinical trial comes with a host of challenges. These include, but are not limited to, intricate protocols, large enrollments, shortened timelines and global sites. By using a benchmarking tool that uses a global dataset experts can develop Fair market Value (FMV) costs.

  • Best Practices Guide To Data Privacy In Clinical Trials
    1/6/2021

    As life sciences companies grow, the regulatory compliance requirements, and risks, expands as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do?

  • Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe
    1/14/2021

    Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.

  • How Biotechs Can Cut The Negative Impact Of Protocol Amendments
    3/5/2021

    When planning a clinical trial it’s common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the inflexibilities of much of the clinical trials industry. Read how having a CRO that can remain focused on being agile and flexible can minimize the impact of protocol amendments on your trial.

  • Attributes Gaining Importance In Clinical Research
    6/29/2021

    What sponsors need from their clinical research partners can shift year to year, which is why ISR asks our respondents about which attributes they believe to be rising in importance when choosing between preferred providers. Below, we share the top three attributes gaining in importance across all clinical phases.

CLINICAL LEADER CONTENT COLLECTIONS

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In this e-book, we take a close look at RWE and RWD. What is it, how is it being used, why all the hype over it, and how the use of it may bring together the worlds of pharma R&D and healthcare. But more importantly, how can we best tap into the data we have available to us today to improve clinical studies and healthcare in the future.

More Content Collections

FOCUS ON PATIENTS

  • The Clinical Trials Transformation Initiative (CTTI), co-founded by Duke University and the FDA, consists of a group of individuals and organizations working to improve the quality and efficiency of clinical trials. This article shares CTTI's goals to improve clinical trials and modernize research, as well as how you can get involved.

  • Designing and conducting clinical trials for rare diseases often requires drug developers to plan for and address many challenges that are often not associated with or are less severe in larger trials for more common diseases and conditions. If they are not adequately addressed, these challenges can result in trial delays or discontinuations. This article shares Cyclo Therapeutics' 3 lessons learned.

  • The rapidly changing regulatory, tax, and global business landscape, driven in part by COVID-19 and ongoing economic and political shifts, means that biopharma executives must keep careful watch over how they implement and monitor decentralized clinical trials (DCTs). This article examines key considerations for biopharma executives in overseeing hybrid or fully decentralized clinical trials.

EMBRACING DIVERSITY & INCLUSION