Earlier this week, China’s State Council announced plans to allow clinical trial data from other countries. As one of the largest pharmaceutical markets in the world, they are looking to bring in new, innovative therapies quicker. This comes on the heels of...
At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan’s “Rational Medicine”...
The life science sector is continually evolving and becoming ever more globalized. What used to work as a business model is progressively challenged by cost pressures, operating performance challenges as more mergers and acquisitions take place, and global trends in...
Beginning in December of last year, all clinical trials are required to adhere to CDISC Standards. The Clinical Data Interchange Standards Consortium (CDISC) is a global not for profit organization with a mission to develop global standards. Through standardized...
Several years ago, clinical trials in India were a booming business. After becoming fully compliant with TRIPS in 2005, India was seen as a favorable place to conduct clinical trials as they boast a huge genetically diverse population, as well as a multitude of...
Building upon last week’s post around the revision to MEDDEV 2.7/1, I wanted to take a quick look at contract research organizations (CROs) and their usage of translation services. Clinical trials are expensive and multi-faceted, as a consequence it is very common for...
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