GUEST COLUMNISTS

• Rethinking Recruitment Plans During The Pandemic

  Once the care and management of current clinical trial participants have stabilized, we can find some silver linings in the pause. Sponsors and CROs can use this opportunity to rethink their recruitment plans, support site sustainability, and intelligently prepare for the ultimate ramp up of trial enrollment.

• Clinical Study Risk Management During The COVID-19 Pandemic

  While COVID-19 has proven to be an extremely trying obstacle for the life science community, it is crucial for organizations to not only focus on the short-term impacts of COVID-19 but on developing a long-term plan of action for how we return to business once the pandemic subsides.

• Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions

  Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.

• What Pharma Can Learn From A Parent Turned Patient Advocate

  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.

• How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials

  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.

• How To Prepare For A GCP Inspection During COVID-19 (And Beyond)

  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?

• How Pfizer Is Using Wearables To Understand The Patient Experience

  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.

• Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits

  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.

CLINICAL TRIAL WHITE PAPERS

• Genetic Counselors - Helping Researchers Brace For The Silver Tsunami Of CNS Disorders

  Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

• Opportunities Beyond Hope: Immuno-Oncology Drug Development

  Explore the role of the immune system in cancer development, as well as the history and challenges of developing immunotherapies for cancer.

• Don’t Settle For Less. Redefining The Core And Scope Of Study Startup

  This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines.

• Making The Most Of Clinical Trial Data

  To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.

• Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies

  Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.

• 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.