White Papers
xMAP® Technology by Luminex
Luminex® Corporation (NASDAQ: LMNX) develops, manufactures and markets the innovative xMAP® Technology with applications throughout the life-sciences industry, and clinical diagnostics. Open-architecture xMAP Technology enables multiplexing of biological tests (bioassays) reducing time, labor, and costs over traditional methods. Systems using xMAP Technology perform discrete bioassays on the surface of color-coded beads known as microspheres, which are then read in a compact analyzer.
Because of an increasing pressure to get product to market, there are four challenges that mean more data must be handled within a shorter time span.
PRA Whitepaper: Sponsor & CRO Pharmacovigilance Alliances – Best Practices to Ensure Success
On a global basis, contract research revenues reached an estimated $21.6bn in 2009, having expanded by more than 10% per year since the mid 1990s. Over the next five years, contract research spending is expected to continue its strong growth, with total revenues rising by 9.9% per year to reach $34.6bn by 2014. While estimates of outsourcing satisfaction vary, it is not uncommon for as many as 35% - 55% of sponsors to report moderate to significant dissatisfaction with a project; according to the report “The Future of R&D Outsourcing” published in 2010 by Business Insights. The best relationships between sponsors and contractors are those that are well defined from the outset. This whitepaper outlines the best practices to ensure success when outsourcing pharmacovigilance services.
Facilitating faster decision making and improved productivity in the pharmaceutical industry
The pharmaceutical and biotechnology industries are currently facing very significant challenges which are resulting on major organizational and operational changes. The trend is for pharmaceutical companies to outsource many of their Research and Development operations to third parties with specific specialities and areas of expertise, in order to focus their own resources on areas where they are in a position to maximize value. A Whitepaper by Mestrelab
Evaluation and Management of Cardiac Safety Using the Electrocardiogram in Oncology Clinical Trials: Focus on Cardiac Repolarization (QTc Interval)
Non-antiarrhythmic drugs have been reported to prolong the QTc interval and induce potentially fatal ventricular tachyarrhythmias. An increasing number of drugs that are used for treating malignancies are no exception. Therefore, both oncologists and regulators expect sponsors of oncology drugs to evaluate, during the development of the drugs, their effects on the electrocardiogram (ECG), particularly on the QTc interval. In the case of agents that cannot be administered to healthy volunteers, the primary approach is to carry out an intense ECG evaluation, employing robust ECG recordings, during early-phase clinical trials, together with characterization of the concentration–QTc interval relationship, and follow this up with an appropriate intensity of ECG monitoring in the later phases of development. This article describes the broad principles of these approaches, including recommendations for exclusion criteria (relative to baseline QTc interval and to cardiac comorbidity); it also describes methods for conducting ECG monitoring and a proposed scheme for the management of any QTc-related effects that may emerge.
Top Reasons Why NetApp for IT as a Service
Evolve to a dynamic data center and deliver business services through a multi-tenant unified cloud architecture.
Wincon: Every step for human health...
Wincon TheraCells Biotechnologies Co., Ltd. is a Contract Research Organization exclusively focusing on providing unique non-human primate (NHP) disease models and services for pharmaceutical companies, biotech companies, medical device companies and academic institutions across the world.
NNIT: IT for life sciences is our core business
NNIT was born as an internal IT department at Novo Nordisk in the pharmaceutical industry.
Caprotec: Capture Compound Mass Spectrometry (CCMS)
After unraveling the human genome sequence the most important challenge remaining is to understand the complex interplay of hundreds of thousands of cellular proteins (the proteome), particularly the critical changes in the proteome which lead to diseases.
Source: www.pharmasummiteurope.com© 2012 GDS International Ltd. All rights reserved.
