Principles in Quality Assurance: the “Grip/Build/Engage” (GBE) Model
Today’s quality challenge is how to implement a comprehensive quality program that ensures sustainable regulatory compliance and continual improvement, while contributing to improvements in business...
View ArticlePharmacovigilance = (Effective + Safe) Therapeutics
Security has become increasingly important in all aspects of modern life, and clinical trials are no exception. In addition to close monitoring by investigators and pharmaceutical company sponsors,...
View ArticleGlobal Pediatric Research
Regulatory and non-governmental initiatives prioritized pediatric drug research to address unmet clinical needs and to improve the accessibility to the pediatric population of innovative and safe...
View ArticlePatient Retention: A Customized Approach
Industry insiders are aware that patient retention is becoming one of the most critical components of planning a successful study. More often than not, study planning is so focused on study start-up...
View ArticleProactively Documenting Requirements for Quality in a Clinical Quality Agreement
Biopharmaceutical companies are under increasing pressure to bring new drugs to market quickly and efficiently while adhering to the highest quality standards. Working with experienced strategic...
View ArticleClosing in on Residual Cardiovascular Risk
From 1970 to the present, the death rate from cardiovascular disease (CVD) has remained essentially unchanged in the USA and other developed countries. Since the general population has aged over this...
View ArticleHormone Replacement Therapy in Menopause: 10 Years Post Women’s Health...
The past decade has seen marked fluctuations in opinions concerning the merits and risks of postmenopausal hormone replacement therapy (HRT). In July 2002, menopause management faced a major turning...
View ArticleRheumatoid Arthritis: New Definition of Remission
It is widely recognized and recommended that current treatment of rheumatoid arthritis should be targeted to disease remission or, if this is not achievable, to minimal disease activity. In agreement...
View ArticleElderly patients: an increasingly relevant patient population.
It is likely that the Europe Union (EU) will face major challenges in relation to population ageing brought about by low fertility levels, improved medical and social care leading to longer life...
View ArticleNew Drug Classes for the Treatment of Type 2 Diabetes
Pharmacologic therapy has traditionally targeted the primary defects in type 2 diabetes including insulin resistance, impaired insulin release and abnormal gut glucose absorption. New drug therapies...
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