EDITOR'S DESK

  • Innovation In Clinical Trials: Is It Time To Change The Paradigm?
    Innovation In Clinical Trials: Is It Time To Change The Paradigm?

    “People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”

    That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.

    Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

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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

  • The Role Of Strategic Partnerships In Meeting Today’s Drug Development Challenges
    The Role Of Strategic Partnerships In Meeting Today’s Drug Development Challenges

    As the biopharmaceutical industry becomes more global, the challenges facing companies become increasingly complex.  The constantly evolving drug-development environment creates intense pressure for them to find solutions that improve efficiency, optimize performance and deliver value.

    Rising operating costs and decreasing economic returns are forcing biopharmaceutical companies to rethink their approach to developing drug compounds. To gain a competitive edge, companies are focusing on generating greater productivity from their research and development (R&D) investment. As a result, decision-makers across the industry are relying more frequently on outsourcing services offered by clinical research organizations (CROs) and are subsequently transitioning from Project-by-Project outsourcing to Strategic Partnerships.

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WHITE PAPERS AND CASE STUDIES

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INDUSTRY NEWS

  • CHMP Recommends Novartis’ Signifor For Acromegaly

    Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the company’s Signifor (pasireotide) long-acting release (LAR) formulation as treatment for certain adult patients with acromegaly.

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    Late Phase Services: Phase IIIb - IV Clinical Trials PRA is a global expert in the design, management and implementation of post-marketing and minimal risk studies for pharmaceutical, biotech and medical device companies.
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    Finding Investigators

    At its core, DrugDev is a living network of 80,000+ investigators across 115 countries built upon a clinical research specific cloud based relationship management and data integration platform. Some of our clients just leverage our network through our professional services, some just use our cloud based systems to get better value from their own investigator databases; more and more clients are using our systems to transform study feasibility and site selection by overlaying their own investigator databases and third party data sources onto our network of relationships.

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    Express Electronic Data Capture (EDC)

    BioClinica’s Express is the EDC solution that brings serious software, superior service, and significant savings to your clinical trial. It makes every part of your clinical trial process more efficient and easier to manage.

  • Site Intelligence & Activation
    Site Intelligence & Activation

    Our industry is faced with lengthened development timelines, increased costs and the need for greater global harmonization and planning across development functions. These changes have also brought increased regulatory challenges and cost pressures. Consequently, PPD’s study start-up process has rapidly evolved over the past five years to address these challenges and increase global coordination and consistency.

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  • Merge eClinical OS™
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  • Marketing Intelligence and Strategic Thinking
    Marketing Intelligence and Strategic Thinking

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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 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.

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  • Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate Governance

    In this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.

  • 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.

  • New Indications For Existing Medical Entities

    This webinar will take a critical view at the diverse technologies that have been proposed for repositioning. 

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FIND A CRO IN SOUTHERN CALIFORNIA

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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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Surviving a FDA GCP Inspection – Preparation Techniques for Success

October 2, 2014
1pm-2:30pm EDT, Online Training

Protocol Deviations: Calculated Risk or Risk to be Managed?

October 6, 2014
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FDA GMP Inspections – Proven Preparation & Survival Techniques

October 9, 2014
1pm-2:30pm EDT, Online Training
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CLINICAL BULLETIN BOARD

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 CLINICAL EVENTS

Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success

October 1, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Surviving a FDA GCP Inspection – Preparation Techniques for Success

October 2, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Protocol Deviations: Calculated Risk or Risk to be Managed?

October 6, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

FDA GMP Inspections – Proven Preparation & Survival Techniques

October 9, 2014
1pm-2:30pm EDT, Online Training

The Vendor GMP Qualification Audit: Ensure Your Vendors Meet Your Compliance Standard

October 15, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate
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