Happy August

OK, Maryland was hot and humid, and they had great, big bugs: big shiny green beetles and big flying things. I'm sure there are others that I missed. Washington, D.C. was interesting, although when I saw the White House, I had to say to myself, "Is that all there is?" The Capitol Building was cool, the Mall was long, the new World War II monument was nicely done, the Lincoln Memorial was enormous, and he seemed to be staring at me wherever I walked in the monument. The work I did there was such a pain in my ass. In fact, I didn't get to do any real work until Thursday afternoon. I could have done all the work from California. It was very pretty there. Lots of green everywhere. Did I mention it was humid? <snip because I already mentioned all of this and why prolong the pain of the memories?> So when we landed in Oakland on Friday night and were told that it was 60°F (15°C) and cloudy, I was thanking heaven for such a small favor. So now I'm back at work, dreading the return to this mess. I really have to wonder if I made the right decision with this job. It's a paycheck, and that's all I can really say right now. So, Happy Monday.

Let's See...

What can I talk about?

I've been working my ass off again. It's finally submission mode for real now. We've...excuse me...I've just started to print our 50-volume submission, and I'll be running around like a dog for the rest of the month to get it all done right. That is really OK because I love this. This will definitely be a test of my mettle. I started working here in the middle of the process, and I'm finishing it up. We'll see if I can really prove myself to the nay-sayers in the audience. I know I can, but you know how it is in Corporate America, it's all about the last project and how well you did with it. Anyway, how could I ever have convinced myself that working in the financial industry would be better than the pharmaceutical industry. And this time it's all topical dermatology. No one dies. No obnoxious CRFs. It's a walk in the park. Still, I could drive the big rigs and be happy as a clam.

And that's where I've been all week.

Case Report Forms

For the "General Edification" file:

CRFs are case report forms, not chronic renal failure. These are the forms that doctors and nurses fill out for the subjects who are part of the clinical testing of new drugs. They record all sorts of data about the patient including their demographics, the standard numbers of weight, height, heart rate, blood pressure, etc., as well as how the drug is affecting the person. In drug submissions, the FDA typically only wants to see CRFs from subjects who experienced adverse experiences either because of the drug or coinciding with usage of the drug, you know, the bad stuff. So even though there may be a thousand participants in the drug study, there might only be a small percentage who experienced some side effect while they were taking the drug, related to the drug or not.

Depending on what kind of drug is being tested on the willing participants in the studies, the CRFs can be very large. The first submission I ever worked on, which ended up being over a thousand volumes of paper at 400 pages per volume, the CRFs were between 200 and 300 pages each, and there were hundreds of them to be scanned to PDF, cleaned up, bookmarked, hyperlinked, etc., etc., all to facilitate the FDA's review process. This drug was for chronic pain management, and it was delivered via pump into the spine. Ick. I guess that's bound to cause some sort of adverse experience or another.

So when I say that the CRFs were not obnoxious, I mean that because the drug I'm currently working is to cure or at least control acne, the forms are not going to be so bad. They were only between 15 and 20 pages each, and there were only about a dozen of them. And no one died because of the drug, so it's really easy stuff this time around. But trying to get a bunch of managers and directors to sit still long enough to read and review seven volumes of material by the end of the week is simply impossible. I just don't understand it. That's one a day, folks! And think, the European agency doesn't want to see any CRFs at all! Even from American drug companies! How lucky are they?

I'm done printing Modules 3 and 5, and I'll start on Module 4 on Friday or Saturday. Another weekend of work, but if I'm lucky, I'll get at least Sunday off. I'm not paid hourly anymore, so I'm hoping that the company will "reimburse" me in other ways after the submission is over. I know I can't get back lost time, and maybe I'm being a little naïve to think this way, but it's what gets me through it all. In the previous submissions I've worked on, I've had to work fourteen or sixteen hour days. This time around, I'm working a regular eight-hour workday. I hope I don't get spoiled by all of this.

In unrelated news, I had a dream last night that I thought I'd share: I'm sitting with Princess Leia (from the Star Wars universe) and I'm talking to her about her long braided hair. I suggested that she wrap her braids up like cinnamon rolls on the side of her head, and voilà, there you go. I'm not saying that I want to be responsible for that funky do, but whatever. Later in the dream, I'm in a very large gymnasium that has a kitchen. I'm making a salad in a big glass bowl when Darth Vader walks in. Well, he doesn't really walk in as much as he has a deliberate pace to get where he's going. Anyway, he finds me and raises his light saber at me. Before he cuts me in half, I raise up the salad bowl and say to him, "Dude, I'm making a salad. Give me a break."

See ya.

Bon appétit

RIP

I Need a Good Slap

As I have indicated in a previous post, I have been very busy lately, perhaps busier than most people in my organization. That's OK with me, really, but I think it's going to my head. This afternoon, or rather during the noon hour today, I heard the projection TV in the big conference room go on to display the Olympic games to those who were seated there. I couldn't tell what was being watched, but I could hear cheers and boos coming from the audience. I didn't really care that they were watching the TV during a lunch hour, but it made me feel a little indignant, arrogant even because I was hard at work while these "slackers" were watching the freaking Olympics. Like what, there's nothing better to do? So, before I go off and send a company-wide e-mail telling those people what for, I need someone to gently give me a kick in the ass and tell me to come down from whatever high horse I'm riding, because you know that the moment the submission in taped up in its boxes, I'll be surfing, reading, taking long lunches, etc.... It's almost over.

And no more comments. Sorry. Until I can figure out how to block the mother fuckers who left over 300 offers to try to increase my penis size (like, that's really necessary), no more comments. You all know how to reach me otherwise. It's not like I get a lot anyway...and I cherish the ones that I do get, and I love you for it, and you know who you are. Big mwah!

Hello Lover

Finally! I've been waiting for this forever. I'm afraid my darling grape iMac might not last much longer, and I must plan, darlings, plan for a future of white polycarbonate surrounding a 20-inch display. Not to mention the 1.8 GHz G5 processor and oodles of RAM. No longer just a pipe dream. Sa-weeet!!