With the method of managing the clinical supply chain in clinical trials firmly established through a period of trial and error along with continual adjustment over decades, it is time to take another look at the current paradigm with the new technologies and processes available. Specifically, we will view the growth in understanding for how data integration can bring huge improvements in operational efficiency and lower clinical material waste levels.
The Physician Payments Sunshine Act, a United States healthcare law, was passed in 2010 to increase financial transparency between pharmaceutical organizations and healthcare entities, such as Healthcare Organizations (HCO) and Healthcare Professionals (HCP). This requires the disclosure of all Transfer of Value (ToV) between these groups, and the Open Payments System was created by the Centers for Medicare & Medicaid Services (CMS) for pharmaceutical companies to report their transactions.
As pharma players rushed towards a quick solution to address the US and global transparency requirements, several segregated systems were created, which worsened existing difficulties with data stewardship.