Communicating the Value of Standards
To me the need for standards in clinical research seems well, quite frankly, obvious but perhaps that comes of working with CDISC for 5 years. In the past few months, I have come to understand that there are many reasons why companies struggle to implement standards and what interests me most, is that it is [...]
FDA – Just Tell Me What You Want
“I just want to know what we need to do?”, “why can’t they tell me what they want?”, “are standards mandated?”, “do we need to be CDISC compliant next year?” These are some of the questions I hear at clients and conferences. And the organisation being referred to is of course the FDA. Well good [...]
eClinical Plug and Play
If you have ever owned a mobile (cell) phone have a look in the draw at home, you know the one, the one filled with all the old chargers that only worked with one phone. I know I have one. Shortly, in Europe, this will be a thing of the past with the introduction of [...]
Social Media for Clinical Research Data?
Keeping abreast of the rapid developments with social media is not easy, particularly in the highly regulated biopharmaceutical environment. Every week, something new happens that prompts debate and outpourings from various sources. So you can imagine my surprise when considering that social networks were really for marketing purposes, I came across a blog in the [...]
Ten Commandments for Effective Standards
About six months ago, I bought an Amazon Kindle. For those unfamiliar with this piece of technology it is an electronic book reader. About a week later, I bought a second Kindle for AJ who was taken with mine and complained that she did not have one herself! There are many discussions about Kindles and [...]
Standards in Style: The CDISC EU Interchange
It is always good to attend a CDISC Euro Interchange to see old friends and enjoy, “Standards in Style”. The event in Brussels had the usual ingredients, a good hotel, an evening event at the Comic Museum and a set of good speakers. However, I do have to admit that I am completely biased in [...]
EHRs, Blogs and Thoughts
I have read two interesting Blogs over the last day or so: one pointed me to the latest social media guidance for the pharma industry from the PMCPA which is one step ahead of the FDA Guidance I wrote about last week and the other was looking at the wider use of EHRs and patient [...]
Reflections from DIA 2: Real time data
Just a quick observation on a trend that I have noticed over the last year or so that I find interesting is the emergence of research organisations and the regulators in using their data more imaginatively. Fergus Sweeney from the EMA, in a panel discussion at the DIA Euro Meeting in 2010, said that research [...]
FDA Social Media Guidance: To be or not to be?
It has been interesting to read over the last few weeks that the FDA have delayed their Guidance on Social Media again. Some see it as irresponsible, as habits are already forming in the biopharmaceutical sector, others have described it as walking around with a blindfold on and hoping they won’t hit anything too sharp [...]
Reflections from DIA: CDISC or HL7?
During a session at the DIA Euro Meeting in Geneva last week, one of the speakers uttered the words “CDISC or HL7”. This is one of those statements that rather grates with me, as it demonstrates a lack of understanding of something that is very important when looking at standards and trying to build better [...]
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