News

DATA INTEGRATION : Universal Data Standards - Are We Almost There Yet? Beyond the Final eFrontier When EDC and EHR Converge Also in this issue : How Washington?s Health Reform Impacts Pharma, Efforts to Reach Consensus on ePRO in the EU, An Intimate Look at the Trial Volunteer Experience, Braving the World of Social Media

Updates on pediatric trials, including news from a recent study.

Cover

Industry news focusing on the people and organizations who work in the clinical trials profession.

The use of CROs to conduct clinical trials, including data management, has increased over the years and will most likely continue to represent a significant part of many companies' clinical research efforts. Consequently, sponsor companies need to be able to budget the costs of these outsourced studies as effectively as possible. No one is pleased when a sponsor company requests bids for a study, or asks a preferred provider to submit cost estimates and the lowest submitted figures are substantially above the amounts expected by the sponsor company.

Perhaps few issues elicit more interest in clinical trial agreements (clinical grants) than the overhead portion of the contract. Clinical trial agreements typically have three parts: procedures, nonprocedures, and overhead.

ISR Reports' data show the CRO industry is improving service delivery, albeit with room for improvement. Not long ago- perhaps as recent as 2005-this chart would have been reversed, when more service providers were missing expectations than exceeding them.

Institutional overhead remains one of the more contentious areas in clinical grant management. There can be substantial variations in these overhead rates from institution to institution with often times little immediately evident reason for the differences. Institution overhead rates in the United Kingdom seem to reflect that same imprecision.