Blogs

A Semantic Model is defined as a conceptual data model in which the model describes the meaning of its instances.  This is a HOT topic when we are talking about web standards.  Being able to describe the metadata in an electronic re-useable way opens up a lot of opportunities for better quality and control.

Kerstin Forsberg is an expert in Semantic Models currently working at AstraZeneca. She has 25+ years of experience in information and knowledge management strategies, standards and solutions across the pharmaceutical, news and automotive sectors.

At this year’s BioClinica User Conference, several breakout sessions will be dedicated to exploring the ins and outs of BioClinica’s Optimizer product.  So what’s unique this year?  Several of these sessions will include presentations by actual Optimizer clients/users from companies that have faced the same challenges that you do.

On Tuesday May 14th, BioClinica will be hosting an all-day complimentary oncology symposium as part of their annual User Conference. The symposium will take place at the Hyatt Regency at Penn’s Landing in Philadelphia and will feature presentations from Key Opinion Leaders on the subjects of medical imaging and cardiac safety in cancer drug development. I am pleased to have the opportunity to co-chair this symposium with my new colleague, Dr.

Note: This blog is part of a series highlighting presentations at the 2013 BioClinica User Conference, a free event for BioClinica customers May 14 – 15 in Philadelphia, PA.

Note: This blog is part of a series highlighting presentations at the 2013 BioClinica User Conference, a free event for BioClinica customers May 14 – 15 in Philadelphia, PA.

Data integration can be a confusing and time consuming process. At this year's BioClinica User Conference, attendees will have the opportunity to participate in a breakout session focusing on this issue.  The session will explore:

We have some really cool new features being released in our eClinical software products, such as the launch of our Express EDCplus solution that puts powerful electronic data capture capabilities in the hands of sponsors and CROs. Before joining BioClinica, I had never worked for a software company and I find the process of determining what gets added to the products and what doesn't pretty fascinating.

We've recently heard quite a bit of industry conversation regarding the touch-points between clinical trial management systems (CTMS) and electronic trial master files (eTMF).  In addition to this blog post, we will be discussing this evolving topic in greater depth at the upcoming ShareFEST 2013 conference in Philadelphia, April 25 and 26.  While there are many questions concerning the integration of CTMS and eTMF, they can typically be boiled down to these:

The collection of data associated with sex or gender in a clinical trial isn’t as straightforward as we would initially think. In fact, it’s amazing just how confusing it can be. First off, there is the difference between sex and gender (no, I’m not talking about the differences between men and women, which would be a topic for another blog). According to the Merriam-Webster dictionary:

I have a relative who absolutely adores my daughter (as anyone with eyes and soul would) and regularly uses his Smartphone to take pictures of her. One evening, while showing off the pictures during a family gathering, another relative offered to download them to her computer so everyone could see the pictures on a bigger screen. She connected the two devices, clicked the prompts to import pictures, and went back to party.

An hour passed before they realized something was wrong.

While they offer sponsors the ability to run faster, more efficient clinical trials, using an Electronic Data Capture (EDC) or an Interactive Voice/Web Response (IVR/IWR) system can be a challenge for any sponsor. Large pharma, small biotechs, CROs, device companies, and academic research centers all go through the same study startup process of determining which data needs to be collected, and how to assure the data is correct and complete. 

Keeping up with FDA requirements can be a full time job. There are several FDA guidances related to using eClinical technology in clinical trials with two released this year alone. I recently conducted a webinar that focused on this topic which included a list of ways to ensure your eClinical technology is FDA compliant. The list appears below.

The innovative EOS  imaging system generates an x-ray of the whole body in 3D using a fraction of the radiation dose it would take to do this with conventional radiography or CT scans.  This represents a major advancement in imaging and one that I expect we will see more of in the future.

The FDA recently organized a meeting to discuss clinical data exchange standards between the FDA and the pharmaceutical industry. There were speakers from the FDA, pharma, and technology vendors. The good news is the FDA is receiving data in Study Data Tabulation Model (SDTM) format, although currently they only receive 35% of the data this way.

As Hurricane Sandy roared towards the Mid-Atlantic, I was hunched over in the driving rain digging a trench to divert pooling water away from my house. Looking up at the clogged gutters that were creating the mess, I couldn’t help but think about the old Boy Scout motto: Be prepared.

There have been several tablet announcements this week. But, one of these announcements is vastly different than the others. It’s not an updated model or a smaller redesign of an existing product. It’s a brand new concept in tablet computing, and is available today. It’s the Microsoft Surface, and its innovative hardware and software have the potential to change the game in clinical trial management.