Insights On Partnering

  1. Want To Know What A Biotech CEO Looks For In A CRO?
    5/21/2012

    Trevena is a clinical-stage, drug discovery and development company founded in 2008. Its founding President and CEO, Maxine Gowen, Ph.D., has previously held a variety of leadership roles, including serving as an SVP for GSK’s Center of Excellence for External Drug Discovery (CEEDD). By Rob Wright, Chief Editor, Life Science Leader magazine

  2. What Do Consultants Look For When Advising Drug Development Companies On CRO Selection?
    5/16/2012

    L.E.K., founded in 1983, is a global strategy consulting firm with offices across Europe, the Americas, and Asia-Pacific. One of its more than 900 employees, Jonathan Kfoury, functions as the VP of L.E.K.’s Boston office, with a focus on R&D, partnership, and commercialization strategy development for biopharmaceutical and medical technology companies. By Rob Wright

  3. A Chief Medical Officer’s Perspective On Selecting A CRO
    5/14/2012

    Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine

  4. Improve Your Site Rating Through A 'Less-is-More' Approach
    5/1/2012

    There exists the temptation to take on as many studies as possible in an effort to gain recognition of its work among sponsors. However, there are pitfalls associated with this approach if sites cannot successfully manage an inflated trial portfolio demanding extensive resources. The oft-cited adage of "less is more" can be applied to several different concepts, but it is certainly an apt phrase in the context of study selection by sites.

  5. Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions
    5/1/2012

    Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood. 

  6. Persistence Leads To High Enrollment: PRA Convinces Client To Stick With Recruitment Strategies
    2/21/2012

    PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. From the start, the PRA study team faced a shortened enrollment period and other timeline challenges, including the protocol’s late delivery as well as problems with the vaccine’s availability. 

  7. Is It Time To Switch Your Paper Trial Master File To An eTMF?
    2/7/2012
    Investigators/institutions and sponsors of a pharmaceutical clinical trial are required to maintain a Trial Master File (TMF), a collection of essential regulatory documents.
  8. Patient Safety Applications Of Bar Code And RFID Technologies
    2/1/2012
    The recent focus on patient safety in U.S. hospitals has yielded a flood of new technologies and tools aimed specifically at improving the quality of patient care at the bedside. This has been accomplished by integrating the physical process of care delivery with medication information and software applications that provide clinical decision support, and quality and safety checks. By Zebra Technologies
  9. ePRO For Late Phase, Post-Approval Market
    1/18/2012
    Over the last few years regulators have begun asking clinical trial sponsors for additional research to evaluate the real-world safety and effectiveness of their drugs, often requesting Late Phase trials or post-approval studies as a condition for continued market approval.
  10. Point Of Care Coagulation For Standardized Monitoring And Dose Adjustment During A Clinical Trial Of A Low Molecular Weight Heparin
    1/11/2012
    The study examined the use of a new low molecular weight heparin versus unfractionated heparin (UFH) among patients with ST-elevation myocardial infarction (STEMI) who had received fibrinolytic therapy and subsequently underwent percutaneous coronary intervention (PCI).