EDITOR'S DESK

  • Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management
    Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management

    As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes and have adequate controls in place to ensure patient safety and data integrity.

    Unfortunately, it is also common for silos to exist in many large organizations. Much of what the data management area might do is contained within that department. What the clinical operations department does might be confined to clinical operations. As a result, not all information generated on vendor interactions will be passed through all of the functional areas requiring access to the information.

    When those regulatory inspectors do show up at your door, it is not uncommon for them to ask “what have you done to oversee this vendor?” or “what evidence of vendor oversight can you produce?” As the sponsor is ultimately accountable for the quality of the data and the study conduct, it is important to ensure that oversight is applied throughout the lifecycle of the study. At the same time, it is important to not duplicate effort, micromanage the vendor, or fix issues that should be resolved by the vendor.  Oversight is essential, but spending time on unnecessary activities can have the effect of decreasing quality.

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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

  • Exposing Patients To The Bigger Mobile And Digital Health Picture – Did We Forget To Tell Them?
    Exposing Patients To The Bigger Mobile And Digital Health Picture – Did We Forget To Tell Them?

    To understand just how far mobile and digital technology can truly influence progress in global healthcare, we first need to form the foundation of the discussion with a few rudimentary facts.

    1. Clinical research (‘a branch of medical science in human beings’) is critical to healthcare.
    2. All patients are human beings.
    3. All stakeholders are current or potential patients.
    4. All stakeholders therefore have a vested interest in progression of healthcare.

    Our current healthcare model is evolving, slowly but surely. How this progression is defined, and how mobile and digital technology can help to speed this along will be explored in this article.

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INDUSTRY NEWS

  • HHS, NIH, FDA Propose New Rules To Enhance Clinical Trial Transparency

    Federal agencies in the U.S. have proposed new rules to promote clinical trial transparency. The National Institutes of Health (NIH) announced the rules in a press release, stating that the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) regarding reporting requirements.

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FEATURED SERVICES AND PRODUCTS

  • Hematology/Oncology
    Hematology/Oncology

    At PPD, hematology and oncology is one of our leading therapeutic areas, from discovery through all phases of development. Our team shares your commitment in the fight against cancer.

  • Endpoint Adjudication Module For eClinical OS
    Endpoint Adjudication Module For eClinical OS

    Increased pressure from regulatory authorities to conduct endpoint adjudication, as well as business pressures to reduce the overall cost of trials, leaves many companies searching for ways to streamline the adjudication processes and shorten clinical trial timelines.

  • Phase II-III
    Phase II-III The stakes are high as your drug enters clinical development in Phase II-III. With your drug’s future on the line, you need to navigate a global maze of patient populations, practice patterns and regulatory requirements, often also languages and time zones, before the goal of regulatory approval is in sight.
  • API Sourcing Support
    API Sourcing Support

    Patheon can work directly with your supplier to meet your specific needs with a flexible range of API support services.

  • Biorepository Services
    Biorepository Services

    LabCorp’s biorepository is a purpose-built biological specimen storage facility located adjacent to the North Carolina Research Campus in Kannapolis, NC.

  • 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.

  • Greenbox Reusable Thermal Packaging
    Greenbox Reusable Thermal Packaging

    Greenbox is the industry’s first and only completely sustainable and reusable thermal management system for cold chain transportation. Created from 100 percent organic-based materials, Greenbox reusable thermal packaging materials are non-toxic, fully biodegradable and suffer no thermal degradation after more than 20,000 uses.

  • Risk Based Monitoring
    Risk Based Monitoring

    In line with recent EMEA and FDA guidance and in support of the industry movement towards remote monitoring, Chiltern has developed a robust Risk Based Monitoring (RBM) model for clinical studies based on direct experience. This strategic approach moves from a classical 100% source document review at site to a more effective targeted data monitoring model, where specific study risks and site performance are continuously assessed. Recognizing that early and ongoing integrated data review by all functions is essential to an effective RBM strategy, Chiltern has produced a customized data monitoring model that is tailored for each individual study site, concentrating resources on risk to data and patient safety. 

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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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    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.

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

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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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 UPCOMING TRAINING COURSES

Stability Programs - Key Factors in Meeting FDA/ICH Regulations

December 10, 2014
1pm-2:30pm EST, Online Training

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
1pm-2:30pm EST, Online Training

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
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

Stability Programs - Key Factors in Meeting FDA/ICH Regulations

December 10, 2014
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

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
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