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

  • The Role Of DCE-MRI In Drug Discovery Support
    The Role Of DCE-MRI In Drug Discovery Support

    Incorporation of Dynamic Contrast Enhanced (DCE)-MRI modality in clinical trials can contribute to discover more powerful imaging biomarkers, compared to conventional MRI, for assessment of early disease changes and for helping select patients most likely to benefit from drug response.

    • Vascular changes can be observed and quantified with DCE-MRI, which allows earlier assessment of drug efficacy and saves time and money in the drug development process.
    • The use of DCE-MRI in studies increases the study’s discriminative power and helps reduce the number of patients and study sites.
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INDUSTRY NEWS

  • FDA Panel Backs Novartis’ Secukinumab For Psoriasis

    Novartis announced that it has received the full support of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) for the regulatory approval of its drug secukinumab as treatment for moderate-to-severe plaque psoriasis.

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FEATURED SERVICES AND PRODUCTS

  • Regulatory Affairs Service And Consultancy
    Regulatory Affairs Service And Consultancy

    The regulatory environment of the global healthcare industry is a continuously evolving forum to support the scientific developments and global awareness of the exacting standards required in order obtain global licensing. Chiltern’s regulatory department tracks all national legislation, draft legislation, guidelines and judicial decisions in their efforts to provide a proactive research program for their clients.

     

  • AdaptaTrial™ Trial Management
    AdaptaTrial™ Trial Management

    The AdaptaTrial™ platform integrates visit scheduling and data collection in one protocol repository. This, along with the overall integrated approach, makes large-scale adaptive clinical trial design much simpler and more cost-effective than would otherwise be possible.

  • 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.

  • eClinical Services
    eClinical Services

    BioClinica helps you get the most from your clinical data by combining best-in-class eClinical technology with expert data management and experience in almost 2000 electronic trials to date.

  • Merge eClinical OS™
    Merge eClinical OS™

    Merge eClinical OS™, our flagship product, is a truly unified platform designed to help clients manage and run studies faster and more cost effectively.

  • 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.

  • CoSign Cloud
    CoSign Cloud

    From large enterprises to small businesses, CoSign is the proper digital signature solution for anyone looking to finally make the move to more efficient paper-free processes.

  • Phase I-IIA Clinical Trials
    Phase I-IIA Clinical Trials

    inVentiv Health Clinical conducts Phase I-IIa clinical trials quickly and efficiently at its dedicated 22,000 square foot clinical facility comprising more than 200 beds in four independent units. An extensive database and relationships with leading hospitals ensures rapid recruitment of study participants for a wide variety of trials.

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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.

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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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