GUEST COLUMNISTS

  • How To Navigate Drug Repurposing And Bridging Studies

    Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

  • How To Build A Strong CRO Partnership And Find Drug Development Success

    Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.

  • Clinical Trial Duration Trends & The Study Closeout Gap

    Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends. 

  • How To Leverage RWE To Facilitate Access To Cell & Gene Therapies

    As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.

  • Improving Diversity In Clinical Trials With A Community-Based Approach

    Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.

  • Latin America: A Compelling Region To Conduct Your Clinical Trials

    This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.

  • IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy

    European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.

  • How Can We Investigate Biomarkers For Lung Cancer Patients More Effectively?

    With a 5-year mortality rate of nearly 90%, lung cancer is in dire need of targeted control interventions. There is a serious lack of sufficient predictive biomarkers, turning the lung cancer journey into one in which the patient and physician alike may as well be wearing blindfolds. This article discusses how we can start to swing the needle in the patient's favor.

CLINICAL TRIAL WHITE PAPERS

  • Tips For Tailoring eConsent For Optimal Patient Centricity
    3/29/2022

    While informed consent is a critical process for ensuring participant autonomy, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. Explore why eConsent is a potential solution to this problem.

  • Breaking The Mold In Clinical Systems Integrations
    1/18/2022

    There is a plethora of data points needed to run a successful trial through to approval. Departments (drug supply, clinical, finance) may have different uses for the same data, and therefore the way they track and communicate the data varies. Learn how this all varies in this white paper.

  • Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs
    7/20/2020

    Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which could lead to delays that create a market shortage that triggers serious health consequences for patients. A clinical supply partner can provide packaging as needed and handle distribution for expanded access and general commercial needs.

  • Report: Impacts Of Decentralized Clinical Trials 2021
    8/10/2021

    Decentralized clinical trials have had the potential to revolutionize studies for a number of years, though in the last two years, accelerated by COVID-19, they have finally started to realize some of that potential.  This final report based on 125 responses reveals unique insights into the adoption of decentralized trials today.

  • FDA Designations for Rare Disease Products: A Complete Guide
    8/27/2021

    This paper highlights the designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Explore the criteria, timeline and maintenance, and benefits of each designation.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Diversity In Clinical Research: Improving Clinical Trial Representation With High-Quality Training
    10/27/2021

    Over the last several years, the pharma industry has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines and in the clinical trial recruitment phase of new drug research and development. However, relatively little attention has gone to diversity within the clinical research workforce, which many industry insiders have suggested can significantly enhance study population diversity.

  • eTMF Implementation Quick Guide
    1/21/2021

    Implementing an eTMF for the first time can feel like a daunting process. This checklist will help you focus on some primary considerations to reduce risks, maintain compliance, and establish effective processes in your eTMF so that your team embodies a culture of inspection readiness from the start.

  • Elevating Effective Outcomes With Companion Diagnostics
    3/22/2021

    Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDxcentral laboratory partner is necessary.

  • Large Research Healthcare System Maintains Compliance Through Internal Program Assessment
    6/28/2022

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

  • High-Quality, Audit-Ready Clinical Research Driven By Digital Data Management
    8/3/2020

    A contract research organization (CRO) focused on quality needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. With a cloud-based, unified IBM® Clinical Development platform, the CRO can now quickly create accurate digital records of every action taken, including granting users access and updating study protocols.

  • Real-World Evidence In Clinical Trials
    8/11/2021

    Recent technological innovations have expanded the potential for the collection of real-world evidence (RWE) in clinical trials. Read how t hrough patients’ personal devices, fixed in-home sensors, or third-party wearable devices (e.g., Fitbit) and biological sensors, researchers can now collect ecologically valid data representing a wide array of constructs.

CLINICAL LEADER CONTENT COLLECTIONS

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The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.

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FOCUS ON PATIENTS

EMBRACING DIVERSITY & INCLUSION