http://www.smartconsultinggroup.com/blog Mon, 28 Jun 2010 23:34:59 +0000 http://backend.userland.com/rss092 en Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared ... http://www.smartconsultinggroup.com/blog/articles/the-future-of-regenerative-medicine Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and ... http://www.smartconsultinggroup.com/blog/announcements/fda-inspection-wizard-whats-scary-can-turn-out-to-be-a-piece-of-cake Diabetes is a chronic metabolic disorder that develops because the body is not able to produce the hormone insulin and/or is unable to respond effectively to the insulin that is produced. There are two types of diabetes: -Type 1, which accounts for 5 to 10% of worldwide diagnosed diabetes cases. -Type 2, which ... http://www.smartconsultinggroup.com/blog/articles/diabetes-trends-until-2025 The medical world is showing its ugly, hostile face to pharma sales reps.  The number of doctors that are willing to meet with pharma sales reps on a regular basis is dropping alarmingly, and the group that doesn't want to meet with them at all is growing even faster. ZS Associates, ... http://www.smartconsultinggroup.com/blog/articles/pharma-sales-reps-facing-a-hostile-world Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day ... http://www.smartconsultinggroup.com/blog/articles/the-secret-to-tissue-regeneratio-in-the-body-of-a-worm After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, ... http://www.smartconsultinggroup.com/blog/announcements/how-to-perform-a-mock-audit Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we're talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day ... http://www.smartconsultinggroup.com/blog/articles/the-secret-to-tissue-regeneration%e2%80%a6-in-the-body-of-a-worm Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company's bottom line.  Nevertheless, the ROI can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance. Within the pharmaceutical industry, it is not easy to find a Quality System model ... http://www.smartconsultinggroup.com/blog/articles/management-responsibilities-and-automation-techniques-in-regulated-pharma-environments-as-per-a-suggested-quality-system-model In April 2010, an important number of the world's top experts in pediatric pharmacogenomics and personalized medicine came together at a unique conference to change the way childhood diseases are treated. The conference was hosted by the Children's Mercy Hospitals and Clinics, and its goal was to apply genomic tools to ... http://www.smartconsultinggroup.com/blog/announcements/advances-in-pediatric-personalized-medicine-are-highlighted-at-unique-international-conference A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor's quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry ... http://www.smartconsultinggroup.com/blog/case-studies/what-you-need-to-know-about-vendor-audits