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

Lessons learned along the journey to merge electronic platforms in clinical research and health care.

Contrary to common belief, the development of follow-on drugs, often referred to as me-too drugs, does not begin after a first new drug in a therapeutic category receives market approval. The reality is that sponsors are engaged in drug development races that are intensely competitive where the first drug candidate to receive marketing approval belongs to the sponsor that got to the finish line with a satisfactory submission the fastest.

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.