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But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above? The Quality Transformation is a culture of commitment to continual improvement read more

Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. read more

As the old aphorism goes, a New Year means a new beginning. It also provides an opportunity for all of us to make New Year resolutions – promises we make to one or more lasting personal goals, projects, or the reforming of a habit. In the world of health policy, this has added meaning. The Government continues to face opposition to its NHS reforms. read more

Change management can be found as a bullet under “critical success factors” in many Electronic Lab Notebook project charters. Touted as crucial in determining the success of an ELN, many agree in principle that change management is needed, but don’t know how to go about making it effective, tangible, and measurable. read more

Ask your colleague, “How can I make it easier for you when transferring over these products?” By doing this you are making the job easier for you and for them. How? read more

One of the consequences of the increasing convergence of science and technology is the nature of the relationship between R&D and IT. As scientists increasingly depend on information technology as an integral component of laboratory work, they become increasingly dependent on the IT infrastructure and IT resources. read more

Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally. read more

As the global CRO community studies how to most efficiently move to fully electronic business processes, there are numerous issues that must be addressed to assure secure global collaboration. These include identity trust, data integrity, regulatory compliance, and time and cost savings. read more

Salamanders and newts can regenerate missing legs, tails and eyes in just weeks! Why can’t mammals possess the same super powers of regeneration as these smaller animals? read more

To determine whether the patentee has right to exclude for a particular claimed invention, it is essential to know what is claimed and this process is called determining the scope of the invention or claims construction. read more

As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug. read more