Timothy Pratt, PhD

Reimbursement in Clinical Trials is a perennial source of concern for both payors and payees. Failure to reimburse appropriately can negatively impact otherwise cordial Sponsor-Site relations; appropriate goes well beyond a determination of "Fair Market Value", however, and extends to timely and reliable payments, with clear and transparent reporting for troubleshooting and Regulatory compliance. In many instances, attempting to provide appropriate reimbursement can prove problematic and a high burden of work. This paper examines how the Clinical Reimbursement process can be greatly improved via the use of eClinical technologies, outlines assessment metrics for the utility of reimbursement systems, and examines a current example of a quality system ranked using those specified metrics.

Non-digital data recording mechanisms have existed for millennia, and due to the inherent nature of the media have produced a distinctly linear thought pattern in most activities including clinical research management. Digital data recording methods, however, open up a broad range of possibilities for data access and capture to operate on a distinctly non-linear fashion. This whitepaper explores what may be achieved with the appropriate Vision, specifically with respect to Trial Master Files and Document Management.

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