• “Everyone’s Risk, Everyone’s Benefit”: The Keys To Effective Strategic Partnerships
    “Everyone’s Risk, Everyone’s Benefit”: The Keys To Effective Strategic Partnerships

    Whether it be a collaboration between Big Pharma companies, a sponsor and CRO, or a pharma company and a research foundation, partnerships are dependent on the proper alignment of goals, trust, and risk management. As the industry is faced with increasing demand for timely drug research and development, partnerships need to be a balance of equals, and both parties need to be ready to tackle whatever challenges might arise.

    Clinical Leader spoke with Mark Scullion, Senior VP, Strategic Resources, from inVentiv Health Clinical to learn more about the changes in the industry that are influencing partnership strategies, collaborative drug development, and innovation. 

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  • A Witness To The History of Outsourcing
    A Witness To The History of Outsourcing

    Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry. 

More From Outsourced Pharma West


  • 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

More Clinical Perspectives


  • Clinical Endpoints:  What Do Payers And Regulators Want?
    Clinical Endpoints: What Do Payers And Regulators Want?

    In 1962, the Federal Food, Drug, and Cosmetic Act added an amendment that requires new drugs to show substantial evidence of effectiveness and specifies that this evidence must be derived from adequate and well-controlled clinical investigations.  Clinical benefits that have supported drug approval in the past include important clinical outcomes – for example, increased survival or symptomatic improvement, as well as effects on established surrogate endpoints – e.g., blood pressure, tumor markers, and serum cholesterol. 

More From The Industry Experts


  • Electronic Drug Accountability Systems: Ensuring Compliance, Safety, And Data Integrity In Clinical Trials

    By Stefan Duerr, Associate Director Of Project Management, Cenduit

    Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits.1,2 A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability.2,3 Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.

More White Papers & Case Studies


  • Merck Posts Positive Phase 3 Data For Osteoporosis Drug

    Merck reported new positive data from the Phase III trial LOFT investigating odanacatib in postmenopausal women with osteoporosis. The company presented its findings at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston.

More News


  • Engaging Investigators
    Engaging Investigators

    DrugDev’s unique combination of technology and relationships ensures you can rapidly mobilize and maintain engagement with the right sites for your study, avoiding lengthy delays and budget blowouts from startup through closeout.

  • Clinical Monitoring
    Clinical Monitoring Our Clinical Monitoring department is driven by our seasoned staff of career Clinical Research Associates (CRAs). Rho CRAs bring vast clinical experience to each trial.
  • Via Pre-Qualified Universal Insulated Shipper
    Via Pre-Qualified Universal Insulated Shipper

    Ideal for clinical trial shipments or other high value payloads

    Via Pre-Qualified Insulated Shippers have been designed to utilize simple packaging configurations, reduce operational complexity, and optimize total cost of ownership. Ensure the efficacy of your valuable temperature sensitive products and maintain regulatory compliance throughout distribution with Via.

  • UX CTMS™ - Clinical Trial Management System
    UX CTMS™ - Clinical Trial Management System

    DATATRAK’s Clinical Trial Management System, UX CTMS™, improves visibility for executive management and gives clinical operations teams more control of their pipeline.

  • 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.

  • 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.

  • eClinical OS Trial Connect Mobile App
    eClinical OS Trial Connect Mobile App

    Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

  • 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.

More Featured Services & Products


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.


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. 

More From Clinical Leader Webinar


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.

Get more info...


Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training

CRA Oversight - A Risk-based Approach

September 23, 2014
1pm-2:30pm EDT, Online Training

It's Ten O'Clock. Do You Know Where Your Trial Master File Is?

September 24, 2014
1pm-2:30pm EDT, Online Training
More Upcoming Courses


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.


Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training

DIA Biosimilars 2014, September 18-19, Washington, DC

September 18 - 19, 2014
Washington, DC

Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel

September 18, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

EDM and ERS 2014

September 22 - 24, 2014
Washington, DC
More Events....