Clinical Guest Contributors

  1. What Pharma Can Learn From A Parent Turned Patient Advocate 4/2/2020

    I am humbled and honored to introduce you to Andrew McFadyen — founder of the Isaac Foundation. Andrew is a husband, a father, and an advocate who tirelessly works to advance actionable dialogue around access, care, and policy for patients with rare diseases. Recently, I had the opportunity to chat with Andrew about the unique challenges that patients and their families face when dealing with serious illness and how we may better serve their needs.

  2. How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials 3/31/2020

    It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

  3. How To Prepare For A GCP Inspection During COVID-19 (And Beyond) 3/27/2020

    Facing an upcoming inspection, in many people’s opinion, is perhaps one of the most stressful experiences when working in clinical trials. But how much of this stress is self-inflicted, and what strategies could be deployed to dissipate and better channel the nervous energy released when the inspector comes a-knocking?

  4. How Pfizer Is Using Wearables To Understand The Patient Experience 3/24/2020

    Learn how Pfizer's Early Clinical Development – Digital Medicine and Translational Imaging (DMTI) team works with internal and external partners to integrate technology into clinical trials, so it can gather robust data on how patients experience disease outside of a clinical setting.

  5. Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits 3/19/2020

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

  6. 8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them 3/19/2020

    The impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity.

  7. What’s Really Behind The CRA Shortage In Clinical Trials? A Root Cause Analysis 3/18/2020

    The #1 and #2 complaints I hear consistently from peers and partners in life sciences companies are the inability to hold third-party partners and CROs accountable for quality performance and to have a consistent experienced team over the life of their clinical trial. The two are inextricably linked.

  8. Clinical Operations In The Age Of A Pandemic 3/12/2020

    The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.

  9. Improving Serious Adverse Event (SAE) Reporting In Clinical Trials 3/10/2020

    Throughout the pharmaceutical industry, patient safety data collected during interventional clinical trials can vary widely across trial sponsors. While sponsors are required to follow the same health authority reporting regulations, there is a lack of standardization across the data fields included on SAE case report forms and SAE paper reporting forms.

  10. Inside Janssen’s Systematic Approach To Patient Engagement 3/5/2020

    Learn about the work of Janssen's integrated, cross-functional Global Patient Engagement Leadership Team, which has been tasked with embedding patient engagement into every facet of the organization. Specific examples discussed include the development of a psoriasis symptoms PRO tool, collaborations with HIV patient advocacy groups, and progress measurement via a patient engagement dashboard.