Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) – A Pathway for Harmonization

Results from clinical laboratory measurement procedures must be equivalent to enable effective use of clinical guidelines for disease diagnosis and patient management. Analytical results that are harmonized and independent of the measurement system, time, and location of testing is essential for providing adequate patient care. The key to generating harmonized results is establishing traceabili...

Global Harmonization of Hemoglobin A1c

Measurement of glycohemoglobin (GHb) is widely used in patients with diabetes mellitus as a monitor of longterm glycemic control (1–3). In addition, prospective randomized clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), have demonstrated that GHb is a measure of the risk for the development of diabetes ...

Global harmonization--a catalyst for safety.

The majority of employers in the United States would not argue the point that the Hazard Communication Standard (HCS) has cost their company an incredible amount of time, money, and grief since its inception. Though it is a great concept, I question whether the HCS, even after more than 20 years in existence, has produced more than a few positive results in the eyes of most employers and employ...

Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.

The 2001 US FDA Bioanalytical Method Validation (BMV) guidance document has been widely accepted and adopted by the bioanalytical community worldwide. As such, it has become the cornerstone of regulated bioanalytical laboratory procedure. In recent years, clarifications to these FDA guidelines and subsequent enhancements were discussed at North American-and European-hosted meetings and conferen...

Definition , Harmonization Cube Indicators & Good Practices