GUEST COLUMNISTS

  • 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?

  • Incorporating The Voices Of Parents And Children In Pediatric Clinical Trials

    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.

  • The Asia-Pacific Region: A Hot Spot For Clinical Trials

    The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.

  • Data-Driven Insights To Improve Your Recruitment Process For Clinical Trials

    Recruitment of suitable patients for clinical trials is a challenge because they are sometimes driven by negative attitudes or a lack of information about clinical trials in general. Unfortunately, the probability that a patient will refuse to participate even after being well informed is considerable. exeo Strategic Consulting AG and Rogator AG performed a robust survey to learn more about why patients are willing or unwilling to participate in clinical trials.

  • Insource, Outsource, Or Both? Choosing The Right Model For Your Clinical Workforce

    While traditional full-service outsourcing is still prevalent (and practically required for small or virtual biotech companies), and some organizations continue to maintain permanent in-house clinical teams, many others — especially midsize and larger organizations — are increasingly taking advantage of other models. 

CLINICAL TRIAL WHITE PAPERS

  • Navigating The Changing Clinical Trial Landscape

    The only way to map a course to a better future is to understand the reality of the current landscape and what perpetuates the status quo. To do this, insight was gathered from those involved in clinical trials. The output of this research reveals the challenges and priorities that will shape the journey to the future of clinical research.

  • China Embraces Decentralized Clinical Trial Solutions
    3/29/2021

    The biopharmaceutical industry in China, like the rest of the world, was forced to swiftly adopt decentralized clinical trial (DCT) approaches to maintain progress during to the COVID-19 pandemic. And, like the rest of the world, its patients, investigators and sponsors were hopeful about the benefits of using these tools. Surveys show patients, sponsors and CROs in China see the benefits of virtual and hybrid trials. Concerns remain around regulatory gaps, digital data collection and study logistics.

  • Early Phase Programs And Development To An Inflection Point
    6/24/2020

    Master protocols are created with hypothesis generation intentions to serve as a method to evaluate product utility across a portfolio of indications in an organized and efficient manner. Herein, this article provides an overview of master protocols with a focus on variations within basket designs, which may be useful for exploratory and hypothesis generating purpose.

  • Bringing Real World Evidence Into Clinical Research
    5/15/2019

    Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

  • Spotlight On Quality In Study Startup
    6/20/2019

    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.

  • Opiod Sparing: Prescribing Less Is Insufficient
    3/31/2021

    Chronic and acute physical pain often requires treatment with strong analgesics. A treatment with opioid-sparing benefits could help mitigate the risks associated with opioids in one or more ways. This white paper analyzes how opioid-sparing benefits could help mitigate the risks associated with opioids, and argues that the opioid-sparing therapy must not diminish the level of analgesia obtained.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Actigraphy For Fibromyalgia
    1/21/2020

    Fibromyalgia (FM) is a neuropathic pain that affects millions of people in the United States. It, like most pain conditions, affects daily activity and sleep. The pain sensations are best measured by recording the patient’s own perceptions (patient-reported outcome) but the related effects of pain on activity and sleep can be measured objectively with actigraphy. Read how actigraphy provides useful insights into the activity patterns in patients with fibromyalgia.

  • Increasing Efficiency And Expertise With A Powerful Clinical Research Platform
    8/3/2020

    A full-service CRO that helps pharmaceutical and biotechnology development firms complete clinical trials and prepare regulatory submissions to the US Food and Drug Administration (FDA) and other regulatory agencies for approval needed an EDC solution that it knew could support a wide variety of studies and study parameters. The IBM® Clinical Development solution armed them with a powerful clinical research platform that provides fully integrated advanced modules, such as medical coding and randomization, that help the organization continue to simplify clinical study processes and increase overall trial efficiency.

  • From Early Adopter To Optimized Trials: Cara Therapeutics And Veeva Vault CDMS
    3/4/2021

    Cara Therapeutics shares how they handle tight deadlines, complex protocol designs, and mid-study changes easily with Veeva Vault CDMS.

  • CRO Selection Taken Seriously
    11/25/2019

    Industry Standard Research (ISR) asked over 500 clinical-development outsourcers their level of agreement with the statement: My organization’s mix of CROs is not likely to change much in the next two years.

  • Ora Streamlines Clinical Trials With Veeva Vault CTMS And BA Insight AppBus Platform
    2/16/2021

    Ora, a full-service contract research organization specializing in ophthalmology, aims to accelerate development timelines for its sponsor clients, so productivity and efficiency are critical to delivering high-quality engagements. To achieve its goal of providing best-in-class clinical services, Ora easily integrates Vault CTMS with other applications using the BA Insight AppBus low-code platform.

  • How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It
    2/2/2021

    The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient centricity but also as contingency planning in the case of a subsequent wave or quarantine. Here we continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.

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