Whitepaper Download – Managing Clinical Trials and Central Laboratory Services in China, by PPD

China's huge population and growing commitment to health care are predicted to make the country the world's second-largest consumer of pharmaceuticals by 2015. However, despite the size of the market, the large numbers of treatment-naïve patients, and the necessity of collecting clinical trial data patients in China before the Chinese State Food and Drug Administration (SFDA) will approve a drug …

White Paper Download – Clinical Trials Benefit From Advanced LIMS

In this White Paper, Robin Longdin of LCG Bioscience and Nick Townsend of LabWare Europe discuss the introduction of a new-generation laboratory information management system (LIMS) into a busy Phase I clinical trials facility. Laboratory information management systems (LIMS) are widely used to automate laboratory processing and to assist with regulatory compliance. Organisations that installed LIMS many years ago are …

White Paper Download – Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing.

This whitepaper by QUMAS explores the importance of sound document management as the foundation for Life Sciences regulatory publishing. When publishing a dossier, life sciences companies typically struggle with efficiently compiling supporting documentation. Usually, this is the result of dealing with paper and electronic documents, legacy versions and incomplete or inaccurate data due to human error. This does not need …

White Paper Download – Streamlining and Accelerating Change Control In Today’s Complex Life Sciences Organizations

In today’s highly regulated life sciences environment, organizations face a myriad of regulations and regulators, affecting all aspects of the enterprise. One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policiesand procedures in a way that is efficient, timely and compliant. A true enterprise solution provides the organization with a single point …