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CLINICAL PERSPECTIVES

  • Single Molecule Measurement: Best Practices In Biomarker Detection
    Single Molecule Measurement: Best Practices In Biomarker Detection

    By Mark Roskey, Vice President and General Manager, Applications and Reagents 

    The human genome encodes thousands of secreted proteins, each of which is an actor in the delicate biochemical balance of diagnostics. Even a slight change in any one of these proteins can mean the difference between sickness and health. Such a change also provides a critical window into the body and helps to direct diagnosis and treatment, however, the vast majority of secreted proteins are present in concentrations well below what conventional technologies can measure, and their role in human health is poorly understood. Researchers have continued to seek ways to detect and diagnose earlier and more accurately through protein detection, and have been unsuccessful at doing so – until now.

  • Intent To Treat Enrichment: A Solution For Better Clinical Trials Of Precision Cancer Medicines
    Intent To Treat Enrichment: A Solution For Better Clinical Trials Of Precision Cancer Medicines

    As cancer medicine increasingly targets specific molecular abnormalities, more of the anticancer drugs in clinical trials are precision medicines, intended to treat a highly selected niche population of patients.  The opportunity for better treatment creates not only a proposition of needles and haystacks, but of hundreds of different kinds of needles sprinkled through thousands of haystacks. 

  • 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.

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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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FEATURED SERVICES AND PRODUCTS

  • 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.

  • Electronic Data Capture (EDC) Services
    Electronic Data Capture (EDC) Services

    As experts in electronic data capture our solutions are designed to integrate into everyday lives through simple, easy to use diaries, questionnaires and assessments delivered to the patients’ own devices.

  • GMP Compliance
    GMP Compliance

    Deficiencies in QMS systems in general and the CAPA process in particular make up a significant portion of FDA 483s (documented findings reported from FDA inspections) and warning letters.

  • Phase IV
    Phase IV

    Understanding the reasons behind product success in a clinic setting and the marketplace is essential. Worldwide Clinical Trials specializes in the design of peri-approval studies focused exclusively on this issue. After evaluation of the study objectives we create a study tailored to your needs, enabling you to consider drug efficacy in treating additional indications, support promotion claims through publication data or evaluate your product against a competitor.

  • Biopharm & Medical Device Vendor Management
    Biopharm & Medical Device Vendor Management

    In today's environment, companies are focusing on optimizing costs and as such, utilize external vendors frequently. However, with organizations increasingly dependent on multiple vendors to support product development, a disciplined approach to vendor management is critical for success.

  • 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.

  • Ensuring Cold Chain Remains Cold And Control Room Temperature Remains Controlled!
    Ensuring Cold Chain Remains Cold And Control Room Temperature Remains Controlled!

    Qualification testing for the newest additions to the World Courier Ground Europe suite of vehicles has just been completed at Cambridge Refrigeration Technology (CRT) and the results are looking very impressive.

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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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Monitoring Informed Consent (IC): Frequently Asked Questions

February 2, 2015
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Regulatory Affairs for Biologics – A Compliance Primer

February 4, 2015
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Surviving a FDA GCP Inspection – Preparation Techniques for Success

February 5, 2015
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Strategic Clinical Project Management: Principles and Practical Applications

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CLINICAL BULLETIN BOARD

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 CLINICAL EVENTS

Monitoring Informed Consent (IC): Frequently Asked Questions

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

Regulatory Affairs for Biologics – A Compliance Primer

February 4, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Surviving a FDA GCP Inspection – Preparation Techniques for Success

February 5, 2015
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Strategic Clinical Project Management: Principles and Practical Applications

February 11, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

ANDAs: FDA Guidance on Stability Testing of Generic Products

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