The Laszlo Letter

Three Developments to Watch

Welcome to my leap-year post!

Although our industry is notoriously slow to adopt new technologies, it is also true that eventually we wake up and attempt to catch up with the rest of the world. With this in mind, here are three developments worth watching:

Google dives into content management and collaboration

Read this to get a feel for the direction Google is taking to take on Microsoft SharePoint on the enterprise collaboration and content management front. Yes, it's a "dumbed down" attempt at the moment but not one to be ignored. While you're at it, check out a currently more serious competitive product from Alfresco.

Adobe Air to unite the Internet with PC applications

Here is a novel thought: Get access to your PC-based applications via the Internet no matter where you may be and even if you don't have your PC with you. Adobe Air plans to enable that but will require an army of developers to make it happen. Read this article to learn more and perhaps check out some already existing applications that use Air. You'll find links to them in the article. As with everything else in life, there is competition. So, don't forget to check out what Microsoft, OpenLaszlo (no relation) and XCerion are doing on this front.

EMC sticks toe in cloud computing waters

Paraphrasing its Wikipedia description, "cloud computing is a massive network of computer servers interconnected as if in a grid running in parallel to maximize computing power per server." While this concept and practice has been around for quite a while under the name of "grid computing" it has taken on new meaning due to the huge investment put behind it by Google to power its own worldwide infrastructure. Since cloud computing has tremendous implications for data storage, it is easy to see why EMC has now purchased Pi Corporation to seed its new Cloud Infrastructure and Services Division. So, check out what's going on here starting with this article. And yes, while EMC also owns the Documentum brand, don't expect this new development to have much impact there in the near future. The big bucks will come from elsewhere. In our own industry, think about "omics" as the most likely place where cloud computing can have a big role.

Reminder: DIA eClinical Meeting - March 16-18, 2008

It's not too late to sign up for the upcoming DIA eClinical meeting that will be held in Washington DC from March 16 to 18, 2008. To see or download the program, click here.

The title of the meeting is "Data Management in Transition: Putting the "e" in Data Management." There will be 63 presentations spread among four tracks:

1. Clinical Data Management - Focusing on the Data
2. CDM/eClinical - Management Best Practices
3. Data Management in Transition - From Keepers of Clean Data to Stewards of the Clinical Data Pathway
4. eClinical Technology Trends and Innovations

The topics to be presented/discussed are summarized on this pie chart. For a larger view in a separate window, hold the Ctrl key and click on the chart.

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Yours truly will be the chair of a panel discussion on "eClinical Futures," a session that will focus on process improvements and emerging information technologies that have the potential to alter the way we currently conduct clinical development. This session will have 5 speakers and will devote significant time to group discussion and audience participation. It is scheduled on Monday, from 1:30 to 3:00 p.m.

Having reviewed the program, here are the topics that I would personally find of interest:

Monday 1:30 p.m. - Track 1 - The FDA Revitalization Act, Drug Safety and Data Management: Great Expectations or Bleak House?

Monday 1:30 p.m. - Track 4 - An Honest Look at the eClinical Process: How Biotech Can Learn from Best Practices Outside the Industry

Monday 3:30 p.m. - Track 2 - Tech(cli)nical Project Managers and Their Role in eCDM

Monday 3:30 p.m. - Track 4 - Standard Representation of Trial Design and Data Management

Tuesday 8:30 a.m. - Track 2 - To Outsource or Not to Outsource? What is the Future of Clinical Data Management?

Tuesday 8:30 a.m. - Track 3 - Redefining Data Management’s Role in EDC

Tuesday 10:30 a.m. - Track 2 - The Impact of the Merger of Merck and Serono on the DM Staff

Tuesday 10:30 a.m. - Track 3 - Statistical Computing Environments: Collaboration through Metadata, People, Process, and Software

Tuesday 1:30 p.m. - Track 2 - Business/Research Value of a Shared Collaboration Platform

Tuesday 1:30 p.m. - Track 3 - A Complex Protocol Design to Accelerate Clinical Trials: How to Implement Multiple Database Lock in an Electronic Data Capture System

Tuesday 3:30 p.m. - Track 2 - CDM without Traditional Clinical Data Management Systems

Tuesday 3:30 p.m. - Track 4 - Connecting Two Worlds: Electronic Health Record Systems Clinical Research

Of course, it makes sense for you to review the entire program to determine which topics would be of the greatest interest to you.

Shire: Clinical Trial Results Website

Shire Plc. has released its consumer-focused clinical trial results web site. You can see it by clicking here.

The site is devoted to completed and discontinued clinical trials that can also be found on the clinicaltrials.gov  or clinicalstudyresults.org web sites. No information on future or ongoing trials are included.

My initial reaction to the site is very favorable. The design is clean, uncluttered and to the point, just what's needed by the average consumer.

Since this is Shire's first attempt at such a site, a few suggestions are in order:

1. The search screen has four pull-down list boxes for Drug Name, Generic Name, Threapeutic Area and Disease State. Since it's possible to select an item from each of these lists, it is very likely that consumers will create combinations that don't make any sense. In such cases, the system will correctly return the message: "0 records found" and leave the consumer confused, dissatisfied or both. So, either make the pull-down lists context sensitive or allow them to search on one list at a time. A small instruction box next to the search function would also help. And, it would also be nice to have a "reset" button in case a consumer wishes to revise their search selections.

2. Clicking the "View Details" link on a search hit opens a study details screen. The most important part of this screen shows the study summary and gives a link to a PDF file giving a detailed exposition of the study. Unfortunately, the study summary simply repeats what the trial was about without giving any of the efficacy or safety results. For that, you have to open the PDF file and search within that for the results section. In addition, the results (once found) are in typical scientific jargon. So, two suggestions are in order: a. provide a plain-language study summary on the Details screen and b. provide a longer plain-language abstract of the whole study via a second link also on the Details screen. (N.B. - Yes, there are legal implications here, but not any that legal and regulatory counsel can't deal with.)

3. The Main Menu also provides a link to a Glossary of relevant terms. The Glossary itself is very nicely done. To make it more effective, it is suggested that a link from each trial Detail screen open a window showing a subset of the glossary relevant to the therapeutic area to which the drug belongs. This would be easy to do by simply adding another field to the Glossary database signifying the therapeutic area.

On the whole, congratulations to Shire for providing a simple but effective tool to consumers.

Virtual Software Testing with StackSafe

It's not too often that I run into something innovative that leads to the thought: "Why didn't I think of that?"

This is exactly what happened the other day on reading the following passage in the February 4th issue of Information Week:

"Two-year-old StackSafe showed how its first product, Test Center, captures snapshots of the IT production environment, stores them, and then assembles virtualized production environments in which to test software changes."

I then found a somewhat longer article on this product here. In that article you can also learn about a competing product called StageManager from VMWare.

What's intriguing about this product is the possibility of replacing the physical hardware and software instance that we currently use to validate software. Instead of continuously maintaining a development, test and production environment, you keep the development and production environments and create virtual test environments as necessary.

Note: If you are new to the concept of virtualization, read this prior post.

By dropping out the physical test environment, you save both hardware and maintenance costs. More importantly, creating a virtual test environment will assure that the tests you run correctly represent the impact of changes on the "real" production environment. Let's face it, the production environment is never exactly the same as the current physical test environment.

A move to such an environment has regulatory implications that must be addressed. First, the validation program itself will need to change and include the validation of the virtual test environment from creation to use to deletion. In other words, you will need to prove that using a product like StackSafe Test Center for validation can be done reliably and consistently. Second, you will need to have some assurance from regulators (e.g. FDA or EMEA) that using virtualization in this manner is acceptable to them. It never hurts to ask!

The unacceptable alternative would simply be to ignore this method and assume that the regulators wouldn't approve.

Requirements Management with SimpleReq

Software Review

Whether a new software application is intended for a validated or non-validated environment, collecting, documenting, managing and using requirements remains a necessary and often daunting task. With this in mind, a small Pennsylvania-based firm called IM Visions has released a straight-forward tool called SimpleReq to help tackle this chore.

Having come from the biopharmaceutical industry, the founders of IM Visions are very much aware of the added rigors related to validation in a regulated environment. They have designed SimpleReq to meet the needs of the traditional Systems Development Life Cycle (SDLC) and of 21CFR11.

In short, SimpleReq is an MS-Office plug-in that will allow you to:

• Categorize and define requirements
• Associate requirements with test scripts
• Generate project documentation
• Manage releases and simplify documentation associated with application maintenance

SimpleReq is available from the IM Visions web site at an annual subscription price of $99.95. This is for a single instance of MS Office running on a single PC. You can select either the MS Office 2003 or MS Office 2007 version.

FDA Information Technology Plan (Draft)

Your chance to comment!

If you or your company is in any way affected by the way the FDA handles your pre- or post-approval activities, then you should be interested in the information technology plan that it plans to use over the next five years.

The draft plan was released on December 27th, 2007. Comments are due to the FDA by Friday, February 22, 2008. The Docket number for this plan is 2007D-0481.

Having read this 37 page document, I can tell you that it will be no easy task to either understand what they want or to collect your thoughts. Never the less, submitting your comments should be a priority. With this post, it is my intention to make it a bit easier to get through the comment process.

Read on...

iPhone and EDC: Screen shots of the Nextrials Prism system

In prior posts, I have talked about the potential use of the Apple iPhone in the life sciences setting. These have included it's use as an SFA device or a solution for EDC & CTM. I have also discussed whether Apple could compete in the business world.

The EDC post revealed how Nextrials is using the iPhone to give its customers mobile access to their Prism EDC system. At that time I promised that I'd try to get some screen shots of the software in action. I am happy to report that the people at Nextrials took the time to have professional photos made for me. So please click the "Continue reading..." hyperlink to see these photos.

On a separate note, Apple has also announced the coming availability of their iPhone Software Development Kit (SDK).  Read this article to get an idea about the SDK. I'm expecting this SDK to be the catalyst that will prompt many existing and new software companies to build applications for our industry.