GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Trial Results Summaries: Improving Patient Communications

    This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

  • Addressing Suggestibility As A Psychological Phenomenon In Clinical Trials

    How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

  • Spotlight On Quality In Study Startup

    This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.

  • EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market

    It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.

  • Mitigating Inherent Risks In Global Sample Processing

    The global demand for specialized sample processing has grown dramatically however despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry fast turnaround and monitored, specialized processing can help safeguard samples.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • The Complex Issues With Developing A Novel Human Antibody From Scratch

    Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.

  • Industry Perspectives On Decentralized Clinical Trials

    Read what was learned in a recent independent research to identify biopharmaceutical industry perspectives on the benefits and barriers of Decentralized Clinical Trials.

  • Sponsors’ Regulatory Responsibilities In Outsourced Trials

    ICH E6(R2) is an addendum to the International Council for Harmonisation E6(R1) that provides Good Clinical Practice (GCP) guidance. Regulatory bodies can issue major or critical findings for non-compliance therefore it is important to understand sponsors’ regulatory responsibilities in outsourced trials.

  • Innovative, Flexible, And Time-Sensitive Packaging Solutions

    Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant - attending to every detail of the process. Learn how several sponsors achieved success through these case-study examples.

  • Actigraphy For Alzheimers

    Alzheimer’s disease is a cognitive impairment, but it can manifest itself in many detrimental ways including alterations in daytime activity levels, sleep quality, and awake/sleep patterns. Read how actigraphy can provide important data when studying patients with Alzheimer's disease.

  • Disassembling Endemic Silos In Pharma Pivotal To Improving The Clinical Trial Continuum

    Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.

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.

More Content Collections

FOCUS ON PATIENTS

  • How Trial Sites & Sponsors Can Deliver On Patient Convenience In The Age Of COVID-19

    For insights on the impact of COVID-19 on patient convenience in clinical studies, and how sites and sponsors should respond, Clinical Leader reached out to Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS) and a nearly 20-year-veteran of the healthcare industry.

  • 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.

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