|
|
|
European Pharmaceutical Contractor
|
|
In the early days, biomarkers were used primarily as physiological indicators for blood pressure or heart rate, as examples. A biomarker is an objective indication of a particular medical state observed from outside the patient, which can be measured accurately and reproducibly.
More recently, biomarkers, such as elevated prostate specific antigen, can be used as a molecular biomarker for prostate cancer or enzyme assays used as liver function tests. A biomarker is anything that can be used as an indicator of a disease state or some other physiological state of an organism.
According to Strimbu and Jorge, the use of biomarkers in basic and clinical research, as well as in clinical practice, has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question (1).
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
Professor Christene Leiper attended Sydney University, RMIT Melbourne, and Bond University, Australia, and achieved a Professorship of Medicine and Life Sciences at Bond University in 2006. She also undertook research at Edinburgh University, Scotland, as part of her PhD. Christene has been a principal investigator for clinical trials, which enables her to operate across many disciplinary boundaries within clinical research in a coherent and productive manner. In 2007, she was appointed Director of Research at a Scottish CRO, which, in turn, led her to start her own CRO, Onorach, in 2009. |
|
|
|
|
|
 |
News and Press Releases |
 |
Digital Manufacturing is a top priority for Life Sciences according to Zenith survey
Zenith Technologies, a world leader in delivering GMP manufacturing
software solutions to the life sciences industry, recently conducted an
industry survey that suggests the digital manufacturing is a top
priority.
More info >> |
|
 |
White Papers |
 |
|
Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control
Berlinger & Co AG
There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
More info >> |
|
 |
Industry Events |
 |
Biotech Showcase™ 2019
7-9 January 2019, Hilton San Francisco Union Square
Biotech
Showcase™ is an investor and networking conference devoted to
providing private and small- and mid-cap biotechnology companies an opportunity
to present to and meet with investors and biopharmaceutical executives during
the course of one of the largest annual healthcare conferences that attracts
investors and biopharmaceutical executives from around the world.
More info >> |
|
|
