GUEST CONTRIBUTORS

  • Trial Navigators: The Key To Increased Patient Participation In Clinical Trials
    Trial Navigators: The Key To Increased Patient Participation In Clinical Trials

    The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent% of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups. 

  • Clinical Trials In The Era Of Precision Medicine: What Needs To Change?
    Clinical Trials In The Era Of Precision Medicine: What Needs To Change?

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

  • A Tactical Approach To Risk Management At The System-Level
    A Tactical Approach To Risk Management At The System-Level

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • Real World Evidence Generation: The Value Of Cross-Sectional Studies, Medical Chart Reviews And Hybrid Designs
    Real World Evidence Generation: The Value Of Cross-Sectional Studies, Medical Chart Reviews And Hybrid Designs

    Cross-sectional studies (CSS) serve as an effective study design option to gather pertinent epidemiological data quickly to support drug development across the lifecycle. Here we explore how a hybrid MCR combined CSS can be an advantageous study design for real world evidence (RWE) generation, and how gaining a better understanding of the implementation of these designs can allow for better future planning, as well as to guide the development of the next generation of real world studies.

  • Navigating The Challenges And Opportunities Of Value Based Health Care
    Navigating The Challenges And Opportunities Of Value Based Health Care

    The rapid shift to VBHC is reshaping markets for medical and diagnostic devices in several important ways. Its incentives significantly affect the purchasing behavior of payers, clinicians and patients – and what device makers must do to win their business. Generally, this includes determining how these various stakeholders define value, and gathering evidence to build a value based purchasing case early in the product development cycle. In this paper, we examine some of the major factors that influence how different stakeholders define value. We then describe a model for mapping stakeholder value that can help drive profitable device development programs in increasingly value driven markets.

  • Making Sense Of The Biosimilars Market - Strategies And Recommendations To Achieve Optimal Market Access
    Making Sense Of The Biosimilars Market - Strategies And Recommendations To Achieve Optimal Market Access

    Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers which make them an attractive business opportunity.. This whitepaper provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues

  • Clinical Trial Disclosure Management: Build vs. Buy
    Clinical Trial Disclosure Management: Build vs. Buy

    The big challenge for study sponsors is that clinical trial transparency remains a “volatile” area with continuously evolving requirements and expectations. Most life sciences companies don’t have the time, money or resources to develop a compliance solution.

More Clinical Trial White Papers

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.

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FOCUS ON PATIENTS

  • Trial Navigators: The Key To Increased Patient Participation In Clinical Trials
    Trial Navigators: The Key To Increased Patient Participation In Clinical Trials

    The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent% of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups. 

  • Clinical Trials In The Era Of Precision Medicine: What Needs To Change?
    Clinical Trials In The Era Of Precision Medicine: What Needs To Change?

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

  • How Precision Medicine Impacts Patient-Centricity In Clinical Trials
    How Precision Medicine Impacts Patient-Centricity In Clinical Trials

    This is the first part of a two-part article that examines the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials.

More From Our Focus on Patients Series

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INDUSTRY INSIGHTS

  • Trial Navigators: The Key To Increased Patient Participation In Clinical Trials
    Trial Navigators: The Key To Increased Patient Participation In Clinical Trials

    The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent% of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups. 

  • Complementing ePRO + eCOA Platforms With Patient Micropayments
    Complementing ePRO + eCOA Platforms With Patient Micropayments

    Sadly, the average drop-out rate across clinical trials is 30%. Greenphire has increasingly seen clients focused on increasing completion rates of patient reported outcomes and bolstering compliance using ClinCard. ClinCard has built-in text reminders for upcoming onsite patient visits and the ability to trigger “micropayments” when select tasks are completed.

  • Curtain Call For The Second Annual Study Stakeholder Collaboration Workshop At DIA 2019
    Curtain Call For The Second Annual Study Stakeholder Collaboration Workshop At DIA 2019

    That’s a wrap on our second DIA global annual meeting workshop, “Setting the Stage for Stakeholder Collaboration.” Everyones engagement turns an idea into real moment of reflection and learning for all. Read more about these collaboration scenerios and what was learned from them.

  • Clinical Trials In The Era Of Precision Medicine: What Needs To Change?
    Clinical Trials In The Era Of Precision Medicine: What Needs To Change?

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

  • A Tactical Approach To Risk Management At The System-Level
    A Tactical Approach To Risk Management At The System-Level

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works July 30 - 30, 2019
2pm-3:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FWD Pharma Conference August 6 - 8, 2019
Philadelphia, PA
FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 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! August 13 - 13, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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