WATERMARK: Pharmaceutical, Biotech, Med Devices. Post-Market Support.

The Ethical Imperative

One of the latest focus of the FDA as well as other regulatory groups such as AdvaMed, PhRMA Code, American Medical Association (AMA), Office of Inspector General (OIG) and now state and large hospital systems; is the idea of gifts to physicians.  It is estimated that marketing expenditures directed to the physicians increased from $3.5 billion in 1996 to $7.2 billion in 2005.[i]  Portions of this budget were for gifts, food, travel, consultancy, speaking stipends and the like.  The New England Journal of Medicine reported in 2007, that approximately 94% of physicians had received food, drug samples, or other reimbursements and payments from industry.[ii]

The responsibility for compliance and independence largely falls with the pharmaceutical, biotech, and medical device industry.  But, with so many guidance documents and with information changing, it is a challenge to stay in compliance and to keep personal trained.  Further, the documentation of compliance and gathering of data can be a daunting task as companies grow or merge and become larger.

Having a strong partner who is steeped in the regulatory environment and can provide web based solutions for ease in the field is critical.  WATERMARK is that partner providing independent IDMC services during a clinical trial and compliance training, web based administration of speaker bureaus, physician gift registries, post-market safety surveillance and outcome registries.  With out knowledge and experience, we keep you in compliance while providing a user friendly web based interface and robust reporting system.