GUEST CONTRIBUTORS

  • Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back
    Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  • Adopting eConsent To Better Patient Experience In Clinical Trials
    Adopting eConsent To Better Patient Experience In Clinical Trials

    Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.

  • Leveraging AI To Assess Clinical Trial Technologies
    Leveraging AI To Assess Clinical Trial Technologies

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • Spotlight On Quality In Study Startup
    Spotlight On Quality In Study Startup

    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.

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

  • The Evolution Of Risk Management In Clinical Trials
    The Evolution Of Risk Management In Clinical Trials

    The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality. Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.

  • Addressing The Data Challenges Of Pharmacovigilance
    Addressing The Data Challenges Of Pharmacovigilance

    As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.

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ABOUT CLINICAL LEADER

Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.

Please take a moment to join our community and discover the benefits of your free membership.

FOCUS ON PATIENTS

  • Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back
    Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  • Adopting eConsent To Better Patient Experience In Clinical Trials
    Adopting eConsent To Better Patient Experience In Clinical Trials

    Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.

  • What The Patient Voice Taught Lilly About Clinical Trial Design & Recruitment
    What The Patient Voice Taught Lilly About Clinical Trial Design & Recruitment

    When you’re diagnosed with cancer, diabetes, an autoimmune disorder, chronic pain, a neurological condition such as Alzheimer’s disease, or another illness, having the safest, most effective medicine is paramount. Knowing a promising therapy is “in the pipeline” doesn’t bring you a whole lot of comfort. You want access to the most advanced medicines now.

More From Our Focus on Patients Series

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INDUSTRY INSIGHTS

  • Cut It Out: The Role of Gene Editing Technologies in Combating HIV
    Cut It Out: The Role of Gene Editing Technologies in Combating HIV

    HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”

  • Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits
    Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits

    CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how  with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.

  • Storing Biologics At Non-Traditional Temperatures
    Storing Biologics At Non-Traditional Temperatures

    Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this article, we’ll explore some of the reasons why this is occurring and the associated challenges.

  • Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back
    Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  • Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?
    Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?

    The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature data and chain of custody in handling is imperative to the pharmaceutical industry of today.  These additional factors partly explain the much higher cost of these therapies as well. The three primary issues are: capacity, regulatory, and risk. We’ll look briefly at all three.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response June 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions July 10 - 10, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $199 - Includes Bonus Handouts!
Mock Regulatory Inspections: How to Get the Most Bang for Your Buck July 11 - 11, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Guidance for Industry “Process Validation: General Principles & Practices” – Whatever Happened to IQ, OQ, PQ? July 16 - 16, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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