GUEST COLUMNISTS

  • An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model
    An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model

    Patient-centricity is not just a buzzword. At Novo Nordisk, we recognize that if we want to develop innovative treatments for patients living with chronic diseases, it is essential to form meaningful partnerships in which our patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates. This shared commitment to forming a true partnership, where patients are routinely included and guide every part of our care delivery model, immediately resonated and took off. Since the program launched in 2015, it has grown from 15 members to more than 120 members from over 20 countries across multiple therapeutic areas — and we are still growing.

  • How Takeda Is Expanding Its Real-World Data Through A Global Myeloma Trial
    How Takeda Is Expanding Its Real-World Data Through A Global Myeloma Trial

    There is more focus than ever before on tailoring treatment plans to the unique needs of patients. One way to ensure we as an industry are delivering the most value is by examining real-world data (RWD) throughout the drug development process.

  • The Journey To Global eConsent Adoption: Where Do We Currently Stand?
    The Journey To Global eConsent Adoption: Where Do We Currently Stand?

    Technological innovation is ongoing and is impacting all aspects of clinical studies, from study start-up through close out. While the shift to digital technologies is pervasive, the informed consent process remains paper based in many clinical trials around the world. Given its inherent inefficiencies and the increasing complexity of clinical studies, the current approach can raise challenges with respect to quality, compliance, and participant understanding. Considering this, sponsors must find new ways to ensure that potential study participants are fully informed, despite the complicated information provided.

  • Patient Group Advances Clinical Trials, Diverts Patients From Unregulated Therapies
    Patient Group Advances Clinical Trials, Diverts Patients From Unregulated Therapies

    For a patient with a debilitating disease, such as pulmonary fibrosis (PF), moments of hope can be few and far between. Many of these patients search desperately for new therapies to improve their quality of life, or possibly cure their condition, sometimes outside of the approved treatments prescribed by their healthcare providers.

  • What Are The Financial Barriers To Site Sustainability, Patient Experience, & Overall Trial Success?
    What Are The Financial Barriers To Site Sustainability, Patient Experience, & Overall Trial Success?

    Since its founding in 2012, the Society for Clinical Research Sites (SCRS) has advocated for rapid and accurate site payments. With her extensive background in clinical research, SCRS founder Christine Pierre had an in-depth understanding of the complexities of the industry and the need for key stakeholders to prioritize timely and accurate site payments using intuitive systems.

  • Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs
    Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs

    Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.

  • Using Social Listening In The Design Of A Diabetes Clinical Trial
    Using Social Listening In The Design Of A Diabetes Clinical Trial

    Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. Read how Diasome is learning about those issues that are most important to patients and healthcare providers by compiling this data and analyzing online conversations.

  • How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)
    How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

More From Our Guest Columnists

CLINICAL TRIAL WHITE PAPERS

  • Putting CDISC Standards To Work

    Read how integrating CDISC standards at the very beginning of a clinical trial, research organizations can leverage powerful analysis tools to cut through much of the tedious, time consuming, and expensive manual work typically associated with collecting, cleaning, analyzing, quality controlling, and reporting clinical study data.

  • 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 Current Biomarker Landscape In Immuno-Oncology

    Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.

  • Gene Therapies In Rare Disease: From R&D To Regulatory Approval

    Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.

  • The Microbiome In Clinical Trials: Opportunities And Challenges

    In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

More Clinical Trial App Notes & Case Studies

CLINICAL LEADER CONTENT COLLECTIONS

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Learn how to find and hire competent CRAs in this free collection of articles highlighting CRA turnover as well as how to spot fraudulent resumes and counterfeit degrees. 

More Content Collections

FOCUS ON PATIENTS

  • An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model
    An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model

    Patient-centricity is not just a buzzword. At Novo Nordisk, we recognize that if we want to develop innovative treatments for patients living with chronic diseases, it is essential to form meaningful partnerships in which our patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates. This shared commitment to forming a true partnership, where patients are routinely included and guide every part of our care delivery model, immediately resonated and took off. Since the program launched in 2015, it has grown from 15 members to more than 120 members from over 20 countries across multiple therapeutic areas — and we are still growing.

  • Patient Group Advances Clinical Trials, Diverts Patients From Unregulated Therapies
    Patient Group Advances Clinical Trials, Diverts Patients From Unregulated Therapies

    For a patient with a debilitating disease, such as pulmonary fibrosis (PF), moments of hope can be few and far between. Many of these patients search desperately for new therapies to improve their quality of life, or possibly cure their condition, sometimes outside of the approved treatments prescribed by their healthcare providers.

  • Using Social Listening In The Design Of A Diabetes Clinical Trial
    Using Social Listening In The Design Of A Diabetes Clinical Trial

    Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. Read how Diasome is learning about those issues that are most important to patients and healthcare providers by compiling this data and analyzing online conversations.

More From Our Focus on Patients Series

LIFE SCIENCE INDUSTRY EVENTS

How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in! October 1 - 1, 2019
1pm-2:00pm EDT, Online Training
Duration:  60-Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events