GUEST COLUMNISTS

  • Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19

    Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

  • Inside Novo Nordisk’s Patient Advisory Board Meetings

    Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.

  • What Patients Are Telling Sites About Trial Participation During COVID-19

    LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.

  • Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity

    Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about COVID-19 therapy approvals, supply chains, and scientific breakthroughs.

  • An Update On Regulatory Guidance For U.S. Clinical Trials During COVID-19

    To preserve integrity in clinical trials and mitigate the need to place clinical trials on hold indefinitely, the FDA has issued updated guidance to support important research and exploration of new treatments. Additionally, the U.S. Department of Health and Human Services’ Office of Human Research Protection issued guidance to assist researchers in applying human subject protection regulations.

  • Diverse Enrollment In Clinical Trials: What Do Successful Research Sites Have In Common?

    Diverse enrollment in clinical research studies is a complex issue that has multifaceted implications for clinical research sites. An understanding of the research site community’s perceived awareness and current ability to enroll these populations is lacking in the clinical trials landscape.

  • Moving Virtual Trials From Aspiration To Reality In Today’s Environment

    With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must.

  • COVID-19 & Clinical Trials: Understanding The Long-Term Impact

    While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs.

CLINICAL TRIAL WHITE PAPERS

  • A Guide To Evaluating eRegulatory Software For Clinical Research Sites

    Researching eRegulatory management software for your investigative site? Start with this easy-to-follow buyer's handbook on the most important features to consider.

  • Successful BYOD In Any Phase

    The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Read more about the Advantages and Misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

  • Botanical Medicines In 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.

  • Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains

    Embracing Importer of Record best practice is key to reducing risk and promoting timely and compliant supply to patients enrolled in global clinical trials. Download Almac’s whitepaper, for information on how to embrace safe, efficient and cost-effective global supply chain operations, through the COVID-19 pandemic and beyond.

  • Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct

    As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • The Benefits Of Blinding of Investigational Medicinal Products (IMPs)

    How blinding benefits both the patient and the investigator and drug encapsulation is an effective blinding method.

  • Six Trends Shaping Tomorrow's Clinical Trials

    Due to the continuous growth in drug development costs, there has never been a greater need for new and innovative ways to support the clinical trial supply chain. Explore key trends that are pushing the innovation envelope.

  • Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF

    Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.

  • Total Transportation Management Saves Company $10.2 Million

    A leading multinational pharmaceutical company approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully-managed transportation strategy. Learn more about our outsourced transportation option that delivered tangible results.

  • Medical University Finds Solution To Track Participant Remuneration

    Concern ensued across the Medical University of South Carolina (MUSC) research faculty and staff when they received notice that departments would need to somehow track and sum all their petty cash, Walmart and Target gift cards, VISA cards and checks issued through Accounts Payable (as there was no institutional research policy standardizing a single type of remuneration payment for clinical research participants). A fellow academic medical school recommended ClinCard by Greenphire which ended up being the perfect solution.

  • Customized Labelling Solution Delivers Seamless Trial

    Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.

CLINICAL LEADER CONTENT COLLECTIONS

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In this eBook, we present seven articles showing the potential of digital health technologies to reform clinical trials. Read about how Fitbit is gathering insightful data on users, how Otsuka is using real-time data to change the trial paradigm, how digital devices can be used to maximize patient engagement, and much more.

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