EDITOR'S DESK

  • The Challenge Of Managing Regulatory Submissions & Correspondence
    The Challenge Of Managing Regulatory Submissions & Correspondence

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • Why We Took A Different Approach To Planning A Conference
    Why We Took A Different Approach To Planning A Conference

    Like you, I have attended a lot of educational events and conferences over the years. I’m sure we both could list some that were unique, valuable, and memorable while others could be simply categorized as “been there, done that.” And since time is my most precious resource, the last thing I want to do is spend this ever-diminishing asset on attending — or planning — a conference that’s just like all the rest.

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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

  • Smarter Supply
    Smarter Supply

    Who knew clinical trial logistics had so much in common with the automotive and high-tech industries? That certainly seems to be the case with trends like just-in-time (JIT),customer-managed inventory (CMI) and vendor-managed inventory (VMI).

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WHITE PAPERS AND CASE STUDIES

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FEATURED SERVICES AND PRODUCTS

  • GCP Compliance
    GCP Compliance

    The FDA continues to increase the number of investigator audits performed each year, with over 700 audits conducted per year in recent years.

  • Clinical Trial Cold Chain Logistics
    Clinical Trial Cold Chain Logistics

    World Courier is the largest, most successful specialty courier company in the world. Each dot represents one of over 140 company owned offices, nearly ten times the number of offices of all other specialty courier services combined!

  • 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.

  • OnPoint Clinical Trial Management System (CTMS)
    OnPoint Clinical Trial Management System (CTMS)

    BioClinica's OnPoint CTMS improves clinical trial management by helping sponsors easily centralize and share trial data.

  • Oncology Testing Services
    Oncology Testing Services

    LabCorp Clinical Trials collaborates with all major oncology centers within the LabCorp specialty testing group as well as a European laboratory1 to provide comprehensive services in anatomic pathology, cytogenetics, immunohistochemistry, FISH, molecular oncology, and proprietary esoteric laboratory testing. These services are integrated into our global central safety laboratory testing, providing seamless management of international drug development efforts in oncology. Our professional clinical and scientific staff can provide consultative services for protocol design to ensure accurate and timely results for each study. LabCorp Clinical Trials offers innovative oncology testing solutions that assist our clients in reaching early and accurate decisions about their drug’s performance.

  • AdaptaTrial™
    AdaptaTrial™

    AdaptaTrial™ is a cloud-based clinical trials management solution comprised of five software modules that may be configured rapidly and accessed securely via the web.

  • Quality Assurance Service: Investigation Trials & Postmarketed Projects Phase I-IV
    Quality Assurance Service: Investigation Trials & Postmarketed Projects Phase I-IV

    The function of Chiltern's independent QA auditing group is to assess, for investigational trials or postmarketed projects (Phases I-IV), the state of compliance with ICH-GCP and/or applicable regulatory requirements, Standard Operating Procedures (SOPs), the study protocol and/or project plans.

  • Preformulation & Formulation Development
    Preformulation & Formulation Development

    Patheon can structure a highly efficient, fully integrated early development program that can accelerate your project to First Time In Man studies and beyond. Whether your goal is to out license or follow through to commercialization, Patheon will also help you to quickly develop a formulation that achieves manufacturability and maximizes value.

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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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PREMIER SERVICE PROVIDER

CLINICAL LEADER WEBINARS

  • 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

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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 UPCOMING TRAINING COURSES

Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

October 28, 2014
1pm-2:30pm EDT, Online Training

The Top Method Validation Mistakes – And How to Avoid Them

October 29, 2014
1pm-2:30pm EDT, Online Training

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training

An Introduction to Good Laboratory Practices (GLP)

November 17, 2014
1pm-2:30pm EST, Online Training
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CLINICAL BULLETIN BOARD

According to the WHO, over 150m people worldwide, are chronically infected with HCV, with 3 to 4m new infections occurring each year. Together they represent a multibillion dollar market for any successful new drug candidate, with Hepatitis C having the most promising products in development.

 CLINICAL EVENTS

Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

October 28, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

The Top Method Validation Mistakes – And How to Avoid Them

October 29, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Pediatric Research Conference 2014

November 6 - 7, 2014
Washington, DC

Outsourced Pharma West Conference & Exhibition

November 10 - 11, 2014
San Francisco, CA
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