EDITOR'S DESK

  • Nektar Therapeutics: Balancing Budgets, Timeliness And Quality In CRO Selection
    Nektar Therapeutics: Balancing Budgets, Timeliness And Quality In CRO Selection

    Selecting a CRO partner is never a simple process. If you are outsourcing a specific aspect of your study, you still need to evaluate a CROs’ expertise and bandwidth to perform the work in order to select the one that best suits your needs. With many pharma and biopharma companies moving toward strategic partnering agreements, the ante has been upped, making selection of the right partner even more critical. Still, some basic selection criteria have not changed over the years.

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CLINICAL PERSPECTIVES

  • BRIC Nations: Divergent Patterns in the Clinical Trials Landscape
    BRIC Nations: Divergent Patterns in the Clinical Trials Landscape

    The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.

  • 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.

  • ‘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

  • Taking The “Risk” Out Of Risk-Based Monitoring
    Taking The “Risk” Out Of Risk-Based Monitoring

    The clinical trial landscape is continually evolving and with it, efforts in the improvement of participant safety and data integrity. CROs are beginning to transition from on-site monitoring, with 100% point-to-point source data verification, toward a risk-based monitoring (RBM) approach that utilizes source data review and more centralized monitoring techniques better adapted for mitigating risk. 

    While RBM has gained considerable attention in recent years, reluctance still remains around the approach—from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes.

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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.

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    Regulatory content across a product lifecycle is abundant, cumbersome, and absolutely critical to both the product and organization's success.  It ensures both corporate and agency compliance and proves accountability.  

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  • Adaptive Trials In Oncology Research Webinar

    Adaptive trial design is critical in all phases of oncology drug development and helps overcome many hurdles of traditional study design. In a recent webinar, PPD’s Dirk Reitsma, M.D., vice president, global product development, and Niklas Morton, vice president, global biostatistics, programming and medical writing, analyzed the incorporation of adaptive trial design in oncology trials. They were joined by Scott Berry, Ph.D., president and senior statistical scientist with Berry Consultants, to assess the early decision making benefits that are critical to the decreasing drug development time and providing increased benefit to patients.

  • Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?

    Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?  Discover key lessons from the field and best practices vital to reap rewards from these countries during Frost & Sullivan’s complimentary webinar. The briefing will benefit any senior manager in the corporate strategy or global marketing areas that focuses on emerging markets, as well as any healthcare company looking to explore BRIC countries.

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FIND A CRO IN SOUTHERN CALIFORNIA

find a cro in drug development

Find a CRO with BIOCOM’s drug development guide which provides a description of each phase along with a list of companies that can accommodate your needs in the drug development cycle.

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Identifying and Closing the Training Gap in Clinical Research

January 6, 2015
1pm-2:30pm EST, Online Training

Building Accountability on Your Clinical Teams

January 8, 2015
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Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
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Aseptic Processing: Preparing Staff and Programs For Compliance

January 13, 2015
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Introduction to Biostatistics: 2-Sample Tests and ANOVA

January 14, 2015
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Identifying and Closing the Training Gap in Clinical Research

January 6, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Building Accountability on Your Clinical Teams

January 8, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Aseptic Processing: Preparing Staff and Programs For Compliance

January 13, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Introduction to Biostatistics: 2-Sample Tests and ANOVA

January 14, 2015
1pm-3pm EST, Online Training
Price:  $349 - Introductory Rate
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