Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
As our New York and New Jersey offices were primarily affected by Hurricane Sandy, not by damage but by all the ancillary infrastructure issues…no way to get out of your neighborhood because of downed trees, then no gas if you do get out. No public transportation, or trains to get into the New York office. No power equals no heat, no way to keep food (if you didn’t buy ice for your cooler in advance, there is no ice). You can charge your phone or get warm or use your computer at our town hall and library, but you will be waiting in line with a lot of people doing the same. I’m fortunate I was able to temporarily relocate with family outside the hardest hit areas. They say that power will be back by Monday, school will start and we can get back to some semblance of normalcy. I am fortunate.
Unsustainable. That is the word that has been bandied about the drug development industry for approximately two years. The bulk of the costs we know are found within the clinical trials part of the process, where pharmaceutical companies apply millions of dollars doing the same processes their own way, over and over, in a proprietary process without sharing of information. There is change underway to change this process various ways, through collaboration; pre-competitive alliances; roundtable think tanks that promote idea sharing among clin op executives; and non-profit organizations, such as the newly-formed TransCelerate.