GUEST COLUMNISTS

  • Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product’s Labeling & Shipment

    When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse. 

  • Co-Creating With Patients: The New Guide To Expanded Access

    Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

  • How AstraZeneca’s Clinical Trials Procurement Team Adapted To The Pandemic’s Demands

    The pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue. As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time and with solid service by third-party suppliers to respond to any shifts in demand. Here's how AstraZeneca's procurement team successfully adapted.

  • What Is Scientific Research Misconduct & Fraud In Clinical Research?

    What does scientific misconduct and fraud truly mean in the context of clinical research? And what are the ramifications for those at fault? This article provides an overview as well as common findings from the DOJ and FDA.

  • Decentralized Clinical Trials: Does Your Strategy Include These Facets?

    Decentralized clinical trials have increased in response to the COVID-19 pandemic, yet this may be due to a convergence of two factors already in play: our reliance on the use of digital health technologies and a move by the FDA and industry toward patient-focused, real-world clinical trials that leverage the technological advances already available.

  • 3 Strategies To Engage With Patient Advocacy Organizations

    Patient communities can offer extremely valuable insights to help ensure the success of your clinical development program. Larger companies have a corporate function with professionals who are well versed in engaging these groups, but how do small companies take that first step to introduce their company to a new patient community? Here are 3 successful strategies.

  • Best Practices for Risk Assessment of GxP Vendors and Inspection Readiness

    Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

  • Cell And Gene Therapies: Solving Six Challenges

    This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

CLINICAL TRIAL WHITE PAPERS

  • Avoid Critical Findings In Your TMF - A Review Of MHRA Findings

    In clinical research, there is great emphasis on the TMF being inspection-ready at all times. However, regulatory agencies still encounter critical findings in the TMF during inspection. The MHRA recently published their annual GCP Inspections Metrics Report covering metrics from April 1, 2018, to March 31, 2019, which include what issues were found during inspections. In this white paper, we take a look at the most common TMF issues and how to avoid them.

  • Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research
    11/30/2020

    Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

  • Complete Buyer's Guide To The Modern Electronic Trial Master File (eTMF)
    9/8/2020

    Implementing an eTMF is critical for Sponsors and CROs that want to reduce burden, increase study capacity, and enable more trials. However, many organizations are not equipped with a modern solution to realize the full benefit and future proof operations. This guide serves as an in-depth overview of how a modern eTMF solution can impact your organization and the steps you can take to prepare.

  • Improve GI Data And Patient Engagement With GI ePRO/eCOA
    2/10/2021

    Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) to improve data quality and integrity. Eligibility decisions based on data  derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. This paper describes the complexity of GI trials in detail and shows a solution that is designed to overcome their significant, but typical, challenges.

  • The Need To Recruit Better: Understanding The Barriers That Keep Patients From Participating In Clinical Trials
    8/17/2021

    Much has been written and discussed concerning the challenges around enrolling enough patients in clinical trials. Poor recruitment and insufficient enrollment stretch study timelines, add costs and can cause studies to fail outright before they can even begin. Some formidable barriers exist that work to keep eligible and interested patients out of clinical trials. By understanding these barriers, we can begin the necessary work to remove them.

  • The Tale of Two Trials
    11/9/2020

    The debate surrounding best practices for patient management and data collection during clinical trials is ongoing. In this paper we take an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests
    11/3/2020

    With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

  • Studying Sedatives In Phase I Studies
    10/12/2021

    A biotech Sponsor approached QPS to conduct a challenging Phase I study, involving a bolus injection of a rapid onset sedative/anesthetic in healthy volunteers. This case study outlines the challenges faced and the solutions put in place to deliver the study successfully.

  • Comparator Sourcing Efficiencies: How To Shorten The Clinical Trial Supply Chain
    7/28/2021

    At a time of increasing restrictions and pressure on the clinical trial supply chain, it's important for trial sponsors to turn to reliable, timely, and ethical sources for their comparator drug and clinical trial supply needs.

  • The New Normal: Virtual Clinical Trials
    11/5/2020

    Virtual(ized) clinical trials, also known as hybrid trials, decentralized trials, remote trials, and direct-to-patient trials is a relatively new method of conducting clinical trials by which parts or all of the trial happen outside of a traditional physical clinic or trial site. This article addresses some frequently asked questions about virtualized clinical trials including key considerations, sponsor requirements, patient recruitment, and regulatory concerns.

  • Transitioning A Phase III Age-Related Macular Degeneration Clinical Trial
    6/8/2021

    A large pharmaceutical company needed to transition their ongoing study after site selection was complete since the current vendor was not able to offer adequate site support. UBC implemented a transition plan and established strong relationships with the previously selected ophthalmology sites within 6 weeks.

  • Retention And Compliance In A Multicenter, Open-Label Clinical Trial
    6/18/2021

    Missing outcome data caused by patient dropout and poor compliance not only jeopardize the scientific validity of a study, but also come at a significant financial cost to study sponsors. Technology and behavioral science offer potential solutions that together can address these challenges through patient-centric design of tools. This case study examines retention and compliance in a multicenter, open-label clinical trial (N=36) with the use of the Linkt mobile application.

CLINICAL LEADER CONTENT COLLECTIONS

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Recruiting minority patients will involve education, building trust, a different type of outreach, and engaging with new site partners. This content collection on Patient Diversity shares some of the efforts being made by sponsor companies to change their recruitment paradigm and include a more representative patient population.

More Content Collections

FOCUS ON PATIENTS

  • Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

  • Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth. Postpartum hemorrhage is the leading cause of maternal death globally — and in the US, it's on the rise. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies. We must drive a concerted, ecosystem-wide effort that scales up clinical research for women.

  • As the rare disease market has expanded, being a patient-centered company has become a necessity as much as an aspiration. When we involve patients early on in our drug development programs, we get valuable insights and can understand their special situations, which helps us design the most effective solutions that meet their needs. Here are my three lessons learned.

EMBRACING DIVERSITY & INCLUSION