Insights On Partnering

  1. Demystifying Fair Market Value

    Confusion exists over the definition of fair market value (FMV) when you ask any biopharmaceutical sponsor or investigative site and this article attempts to demystify some
    basic factors related to FMV principles, with the goal of fostering improved understanding and dialogue on FMV issues.

  2. Grant Payment Practices: Five Requirements For Stronger Investigator Relationships

    In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).


  3. Leveraging Investigator Grant Payment Practices To Enhance Sponsor-Site Relationships

    One of the world’s leading pharmaceutical companies, AstraZeneca, has over 67,000 employees. Among those are about 13,000 at 17 principal research and development centers in eight countries — including the United States.

  4. This Is NOT Your Sponsor’s CTMS

    Sponsors do have their own CTMS or EDC systems and sites log into them to enter clinical data for a given sponsor or trial. But none of these systems belong to the site and none are devoted to the business operations of the site across all studies.

  5. Physician Payments Sunshine Provisions Of The Patient Protection And Affordable Care Act: Ensuring Compliance Using e-Payment Solutions

    Starting on January 1, 2013, the Physician Payments Sunshine provisions, which are included in the PPACA, require manufacturers of drug, device, biologics and medical supplies to record gifts and payments made during clinical trials and to physicians and teaching hospitals. In clinical trials, grant payments for investigative work are usually made to investigative sites rather than to the physicians themselves, making it difficult for sponsors to accurately measure and report this vital information. By Samuel Whitaker, CEO and Co-Founder of Greenphire

  6. Don’t Brand Your Patients

    Positive Brand development is an important component of any business’ growth, and can be crucial to your site's future viability. However, there are times when NOT putting your logo in the forefront is actually the best thing you can do for your site’s Brand?  Such exceptions to this practice is in the case of patient reimbursement.

  7. The Soft Science Of Choosing A CRO

    Small CROs have had a harder time competing in recent years against the worldwide giants of the field — Quintiles, Covance, PPD, Charles River, ICON, to name a few — in large part because the scary financial environment has prompted pharma and biotech executives to play the safer hand of choosing a large provider to handle their clinical services needs, even when a smaller vendor offers the same services at a competitive price. By Jacquie Mardell, Anhvita BioPharma Consulting

  8. Want To Know What A Biotech CEO Looks For In A CRO?

    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

  9. What Do Consultants Look For When Advising Drug Development Companies On CRO Selection?

    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

  10. A Chief Medical Officer’s Perspective On Selecting A CRO

    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