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Genzyme: Biostatistics with Waban SCE

A few posts ago you heard me rant about the inexplicable secrecy that tends to surround large biopharma IT projects. So, it's with great pleasure that I can report that not all biopharma companies wish to keep everything to themselves.

Specifically, I want to draw your attention to a recent article in eCliniqua and Bio-IT World related to Genzyme's implementation and use of the Waban Statistical Computing Environment (SCE.)

As you will learn from the article, “Waban offers a completely controlled environment where everything done to data is audit-trailed, including when information gets handed off from clinical data management to biostatistics and from biostatisticians to medical writers,” says Dana Soloff (Genzyme’s director of statistical programming.)

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Apple iPhone for EDC and CTM

Prism02 As a person who regularly sticks his neck out with the ever present danger that it may get cut off, I was pleasantly surprised today by an announcement from Nextrials. Specifically, Nextrials made the announcement that its Prism clinical trials management (CTM) and electronic data capture (EDC) platform is now accessible via the Apple iPhone.

In this particular case, Nextrials is agreeing with me that the iPhone does have a place in the corporate setting. In prior posts, I talked about the use of the iPhone for sales force automation (SFA) and discussed why the jury is out whether this phone can succeed in the business world.

Now, Nextrials is showing that the iPhone can also help run and manage clinical trials.

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The Real Thanksgiving

First, let me wish you a wonderful Thanksgiving.

This one is my favorite holiday. It's really the only one where the empasis is on friends and family and does not bring with it a host of obligations. You can simply get together with those you love and have a good time.

So, we owe a thanks to the Pilgrims who landed at Plymouth back in the 1600's and the Wampanoag native american indian tribe that helped them survive and celebrate their first thanksgiving in Massachusets.

So, if you care to know about how all this happened and its aftermath, read on. Then, if you are really interested, follow this link to find out what separates myth from reality about the Thanksgiving story.

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Random Thoughts: Women in Leadership Positions

and why we need more of them in this industry.

Womentalk I have always been amazed that when my wife and I meet another married couple, she is able to find out everything about their families from the wife in roughly 20 minutes. I, on the other hand, may become the best friend of the husband and fail to know, perhaps even after two years, that he has two brothers and a sister. And therein lies a great difference between men and women. Women are simply better at communicating.

So, why does this lead me to conclude that we need more women in leadership positions in our industry? There are probably many reasons but only one that led me to writing this post. It's about an incident fairly recently wherein a very large pharma company forbade one of their employees from giving me a copy of his presentation at a very public meeting and also (politely) asked me not to write anything about the talk.

While I was not surprised by this incident, I still managed to get pretty upset about it. And that's when I realized that this was male testosterone (theirs, not mine) at work. Inexplicable, irrational, illogical and infuriating. Yes, I know I'm getting emotional about this but only because such behavior has consequences. This crazy focus on secrecy (read: lack of transparency) inhibits progress. We need to learn from each others triumphs and failures so the entire industry can grow.

This is why we need more women in leadership roles. They know much better how to communicate and collaborate. Wrapped in all that is a greater degree of openness that values discussing the bad as well as the good.

Now please excuse me, I have to go work a bit on my feminine side.

Havidol: Just don't take this too seriously

Havidol The October issue of Pharmaceutical Executive came with a supplement entitled "Guide to Branding." Unlike most people, I tend to look at these supplements before relegating them to the trash bin. And so, it was with distinct pleasure that the article on Page 8 led me to the following web site:

                                                          Havidol

Check out the site. Then read the article.

Just don't try to get an Rx for this stuff from your physician!

FCG: ECM with FirstPoint

Splogo Jennifer Wemstrom of FCG introduced the FirstPoint Life Sciences ECM solution at the Trends 2007 conference held on November 8, 2007 in Princeton, New Jersey.

Note: This is one of many posts related to the Trends 2007 conference. Each post about this conference uses the same illustration shown to the left.

FCG, already well known for its FirstDoc solution suite, has been working closely with Microsoft to plan, design and implement this new Sharepoint (SP) based solution.

Jennifer was quick to point out that FCG will continue to support the FirstDoc platform and that the FirstPoint solution was not simply an attempt to create an FirstDoc-equivalent solution on SP.

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Revised blog layout

For quite some time I've been concerned that there was too much empty real estate on each blog page. Specifically, there was a pretty wide empty margin on both the left and right sides. I let this go since I did not know how to fix this situation and never had the time to get into it. Then, TypePad, the company I use to host this blog made things easy for me. They sent a news-bulletin specifically showing how this margin issue could be solved. So, I went ahead and did it.

Now, I just need some feedback from you to make sure that I did not create any new problems in the process. Specifically, since your computer display may be set at a lower resolution than mine, you may see some of the page cut off. Now, I hope that this is not the case. But, if it is, please let me know.

Microsoft: ECM with Sharepoint

Splogo Trends 2007, the first conference devoted to Microsoft Sharepoint in Life Sciences, was held on November 8th, 2007 in Princeton, NJ.

As most of you know, Sharepoint is Microsoft's offering for enterprise content management (ECM). Although it has been used to some extent in Life Sciences, the domain areas have been everywhere but in a regulated environment. With the release of Sharepoint Server 2007 and industry-focused solutions from First Consulting Group (FCG) and NextDocs, the time for Microsoft as a viable contender in a regulated and unregulated environment has arrived.

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