Aug 24, 2017 | Clinical Trials
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”...
Aug 17, 2017 | Clinical Trials, Linguistic Validation
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...
Jul 27, 2017 | Clinical Trials, FDA
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...
Jun 8, 2017 | Clinical Trials
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...
Mar 23, 2017 | Clinical Trials
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...
Mar 16, 2017 | Clinical Trials
Last year the EU saw an update to the MEDDEV 2.7/1. This 4th updated version of the guideline not only increased in magnitude, but also brings forth more strict requirements for Clinical Evaluation Reports (CER) in Europe. What does this mean for translation? In some...
