GUEST COLUMNISTS

  • How to Optimize Success in Clinical Trials of Antidepressants

    In order to bring promising therapies safely, effectively, and expediently to the millions of individuals who suffer from major depressive disorder, we need to reevaluate learnings from the past few decades to overcome the challenges in design and conduct of clinical trials for antidepressant drugs.

  • Diverse Patient Populations In Clinical Research: 3 Steps For Success

    While the clinical trials industry has made incredible strides raising awareness among the broader general population, as we’ve witnessed firsthand amid the ongoing COVID-19 pandemic, there remains a persistent lack of representation in clinical research among diverse communities. How do we address this?

  • Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

  • Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare

    The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! Here's what you can do to position yourself for success.

  • Is Your Site Selection Process Optimized?

    Our current approaches for assessing potential sites is not keeping pace with the increase in trial complexity observed across the industry. By adjusting our strategy during this critical state of a trial, we take a step toward improving overall clinical trial performance and ultimately advancing treatments more quickly and efficiently.

  • How To Navigate Compliance With FDA’s 21 CFR Part 11

    21 CFR Part 11, the FDA's regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?

  • FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

    The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

  • The 3 Secrets To Becoming an Effective Leader In Clinical Research

    Experience in clinical research provides a solid foundation, which better positions you to launch your career into management- and executive-level roles. However, you will move away from operational execution and will be called to develop the skillsets and level of confidence required to lead and guide teams. What are the 3 skillsets to understand, develop, and refine your journey?

CLINICAL TRIAL WHITE PAPERS

  • Making The Most Of Clinical Trial Data
    5/22/2019

    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.

  • The Next Generation Of Trial Master File Systems
    11/20/2020

    The next generation of eTMF systems are coming into their own. They use Artificial Intelligence and Natural Language Processing (NPL) to improve efficiency, preserve one version of the truth, and maintain audit readiness. The following paper covers the current state of eTMF technology and the future level of functionality that users can now expect.

  • Improving Regulatory And Operational Performance In Orphan Drug Development
    7/30/2019

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  • Facilitating Patient-Led Research: How Increased Data Access Can Increase Patient Enrollment And Engagement
    2/4/2021

    Having access to millions of patients offers an opportunity to provide study designers the ability to transform clinical trials. After all, ready access to such an enormous and diverse patient population should facilitate enrollment in an unprecedented way, while enhancing and supporting patient engagement like never before. This paper shares how a robust patient database is one critical key that impacts multiple facets of a trial, leading to more successful outcomes that put patients at the center of research.

  • Factoring The “What Ifs” Into Supply Forecasting
    8/24/2020

    Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Getting Every Detail Right – With No Time To Think About How
    2/21/2020

    With a customer racing to beat a competitor to registration with last patient out to database lock in two weeks, this CRO was able to step in and take charge and the study was completed on schedule.

  • Phase III Rare Disease Rescue
    1/2/2020

    A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections. After nearly 16 months, patient enrollment was still a major challenge, the study was over budget and CRO staff turnover on the project was extremely high. Catalyst provided a blinded and unblinded monitoring team that reported into the Sponsor’s CTM using Catalyst’s SOPs allowing the Sponsor to retain control of their program.

  • Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track
    12/7/2020

    Travere Therapeutics is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

  • Critical Milestones Achieved Ahead Of Schedule In Lung Cancer Study
    6/28/2019

    Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.

  • FDA Inspections Need Not Be Stressful
    6/30/2020

    As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.

  • Leveraging Expertise To Exceed Immunotherapy Customer Goals
    9/17/2019

    A biologics company needed a CRO with a dedicated oncology team to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.

CLINICAL LEADER CONTENT COLLECTIONS

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Many in the industry believe AI will be a game changer in drug development. Imagine a future where researchers can identify available patients, their location, the best sites and CROs to partner with, and the probability of success of trials before they even begin. Our latest e-book from Clinical Leader explores the promise of AI.

More Content Collections

FOCUS ON PATIENTS

  • The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

  • Pediatric trials are far more complex than simply evaluating a therapy in the context of a child’s disease or illness. They are a family affair that must accommodate the diverse needs of parents and other family members caring for those children. This article discusses recent survey findings from the Center for Information and Study on Clinical Research Participation.

  • While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

EMBRACING DIVERSITY & INCLUSION