It's the first Monday Morning Briefing since Labor Day, so today's news has a distinctly darker-than-normal hue. Here are the breaking pharma stories you need to know about this morning.
Our CEO, Mark, will go to incredible lengths in search of new CDISC knowledge. Last week, he travelled 5,771 miles to attend this year’s CDISC Asia/Japan Interchange in Tokyo. Between all the sightseeing, sushi and sake, he was able to seriously indulge his CDISC otaku side with some of the leading regulatory experts from around the globe. A diverse list of distinguished speakers and attendees participated in what Partha Chakraborty, Asia-Pacific CDISC Coordinating Committee Chair, called a “game-changer in the Asia-Pacific region for CDISC awareness and standards implementation”.
Ever feel like your sponsors’ requests are never ending? Are you restricted by the EDC system(s) you work with? Do you long to design studies in one tool and build out to multiple systems more easily? You’re not alone!
At the end of last year I wrote a blog post which looked at maintaining standard metadata libraries and transferring this metadata to various EDC systems through our suite of Transform for EDC products . The latest release in this suite is Transform for OpenClinica and I thought I would provide a little insight into the development of this product.
Have you ever found yourself looking for a simple way to transfer your study metadata to an EDC system? This can prove tricky as different EDC systems utilize different import mechanisms, and use a variety of formats, as well as having their own proprietary metadata. To combat this issue, we have created a suite of ‘Transform for EDC’ products which work in conjunction with our data acquisition design tool.
We all know that the end-to-end clinical trial process is becoming more complex and more heavily regulated, week on week, by authorities such as the FDA. We regularly learn of customers and industry professionals who are outsourcing to Contract Research Organizations (CROs) to undertake their studies, and it is becoming increasingly more popular - around 40% of drug development is currently outsourced.
Pharma, Biotech or CRO - whatever type of organization you belong to, if you are running clinical trials, you will be aware of the number of new standards coming your way. Or are you? And does being aware prepare you for the reality, or putting these into practice?