EDITOR'S DESK

  • Three Critical Steps To Rescuing Your Clinical Trial
    Three Critical Steps To Rescuing Your Clinical Trial

    You did all of the required due diligence. You took the time to select what you felt was the right CRO. You verified its track record, qualifications, and expertise. You even took the time to personally visit the site, to ensure the two companies would share a common culture and commitment to quality. Still, despite all of your efforts, the trial was not going as planned. The last thing anyone wants to do is switch CROs in the middle of a trial. But if you get to the point where making a change is your only option, how do you best accomplish this difficult task?

    Alicia McNeil and Elizabeth Kelchner, clinical data scientists for Rho, a full-service CRO, know personally how difficult this task can be. The company has years of experience working on dozens of federal and commercial rescue studies for clients. In their positions at Rho, McNeil and Kelchner are often called upon to resolve issues that arise whenever a clinical study does not go as planned with the CRO originally selected by the sponsor. This experience has taught them how to properly identify the red flags that indicate a study may not be going as planned, and is in need of remediation.

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CLINICAL PERSPECTIVES

  • FDA Safety Labeling Requirements
    FDA Safety Labeling Requirements

    Prior to 2007, the U.S. Food and Drug Administration’s labeling authority was limited; the agency could only request changes to the labeling of approved drug products. That changed, however, with the enactment of the Food and Drug Administration Amendments Act of 2007, in particular, section 505(o)(4). In that section, the FDA was given new authority to require safety labeling changes for approved drugs.

    This means the FDA can now order labeling changes if it becomes aware of new safety information that it believes should be included in the labeling of a drug. This article summarizes the FDA’s thinking in this regard, as indicated by its guidance released in recent weeks.

  • Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
    Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

    Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

  • ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development
    ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development

    Emeritus Professor of Clinical Pharmacology, University of Sheffield, UK; Vice President of Translational Sciences (Certara); Head of Consultancy (Simcyp (Certara)); and Chair of the Board of Pharmaceutical Sciences, International Pharmaceutical Federation. By Geoff Tucker

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FROM THE INDUSTRY EXPERTS

  • The Language Of Our Industry
    The Language Of Our Industry

    True character and the quality of our thoughts are revealed in the way we talk about ourselves and the events in which we participate. We may purposely affect certain patterns of language, but the real thing is sooner or later uncovered.

     

    Or something like that. We also know we have to walk the talk, as the more succinct saying puts it. Considering specifically the language of the contract drug discovery, development and manufacturing industry, in a recent outsourcing survey conducted by contractpharma.com, 75% of respondents said that they would use the word “partnership” to describe their relationship with their contract service providers. That has to be good news for both pharma sponsors and the CROs/CMOs around the world, and points to an improvement in level of service delivered by the latter.

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WHITE PAPERS AND CASE STUDIES

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FEATURED SERVICES AND PRODUCTS

  • CoSign Digital Signatures
    CoSign Digital Signatures

    Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records.

  • Marketing Intelligence and Strategic Thinking
    Marketing Intelligence and Strategic Thinking

    Nice Insight offers products and services focused on a variety of marketing intelligence needs. Whether you need a macro understanding of the contract manufacturing industry, or a micro understanding of particular providers and capabilities, Nice Insight can help with your market research needs.

  • Central Safety Testing
    Central Safety Testing

    Routine testing services include standard safety profiles, such as general chemistry, hematology, toxicology/drug screening, urinalysis and allergy – while our innovative esoteric testing covers both nongenetic and genetic testing in such areas as infectious diseases, oncology, pharmacogenomics, and molecular and biochemical genetics.

  • Institutional Review Board (IRB) Solutions
    Institutional Review Board (IRB) Solutions

    Whether you are a central IRB in North America or an IRB or Ethics Committee affiliated with a hospital, Trial Interactive has the ideal solution to streamline your processes.  

  • Polar Pack Gel Packs & Foam Bricks
    Polar Pack Gel Packs & Foam Bricks

    Polar Pack® gel packs and foam brick refrigerants are designed to provide reliable temperature protection for a vast array of products and packages.

  • eClinical OS Trial Connect Mobile App
    eClinical OS Trial Connect Mobile App

    Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

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CRO LEADERSHIP AWARD

                                       
Life Science Leader developed the CRO Leadership Awards based on industry leading research conducted by Nice Insight. This award helps pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logo above to visit this year’s winners.

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 in an efficient manner. 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.

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April 29, 2014
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Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers

April 30, 2014
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Risk-Based Monitoring for Clinical Trial Sites – Keys to Successful Implementation

May 1, 2014
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1pm-3pm EDT, Online Training
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