Clinical Trials Project Management

Applied Clinical Trials has issued a new free e-book titled “Clinical Trials Project Management”.

According to the website: “Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this e-Book seeks to instruct others on best practices.”

The book addresses: Project managers view of functional outsourcing; What to expect in budget variances; Negotiating positively with sites; and Fair Market Value pricing for contracts.

For further details, see ACT.

Posted by Tim Sandle

ISO 15189:2012

ISO 15189:2012 ‘Medical laboratories — Particular requirements for quality and competence’ is a new standard intended to improve the quality and reliability of medical laboratories. The standard aims to provide advice to clinicians; and cover such areas as collection, transport, reception, and examination of samples and finishing with their reporting and interpretation.

ISO 15189:2012 is closely aligned to the requirements for testing and calibration laboratories ISO/IEC 17025 and the widely respected quality management standard ISO 9001.

Posted by Tim Sandle