The Laszlo Letter

Briefly Noted: IT articles in Contract Pharma

In case you are not a regular reader of Contract Pharma, I wanted to make you aware of three articles that appear in the March 2011 issue:

The first reviews the current market for Laboratory Information Systems (LIS) and their Electronic Lab Notebook cousins. The ability to share data via standard data models is discussed. The impact of outsourcing on LIS is also covered.

The second covers the importance of standards for data sharing. This time it's not about CDISC but the need for similar standards in the manufacturing and supply chain arena. Reference is made to the Pistoia Alliance;

The third discusses IT investments in the areas of drug discovery, drug development, supply chain and manufacturing and sales/marketing. Special focus is placed on the role of IT when operations are outsourced.

Software for Clinical Development - 2011 Edition

It's finally here!

The 2011 edition of Software for Clinical Development is now available and it's still FREE.

Download 2011-ClinDevSoftware-LaszloLetter.

As before, this comprehensive guide comes to you as an MS Excel spreadsheet so you can slice and dice it any way you wish. Over 200 solutions from 95 vendors are represented and categorized by solution area. The following pie-chart will give you a pretty good feel for this.

 
Most of the acronyms should be pretty familiar to you. If you don't know some of them, it's likely that you have no interest in that category anyway. But, there are a couple that may be unfamiliar to most of you: 

RIMS - Regulatory Information Management System

MIMS - Medical Information Management System

Of course, a glossary defining all of the acronyms is included in the spreadsheet.

As you would expect, over 50% of the solutions come from just 5 categories:

• EDC - Electronic Data Capture
• CTMS - Clinical Trial Management
• ePRO - Patient Reported Outcomes
• CDM - Clinical Data Management
• IVRS - Interactive Voice Response

What's more interesting are the emerging software categories that include:

• Data Analysis
• RIMS - Regulatory Information Management
• CDW/CDR/SCE - Clinical Data Warehousing/Repository and Statistical Computing Environment
• Patient Recruitment

Can Frog Design figure out Healthcare?

If you have not heard of Frog Design, it's worth checking out what they have done over the years. I won't talk about that here and let you do the research. I promise, it will be fun!

But, I would like to get your opinion on what Frog Design and Microsoft are dreaming up to solve the ills of Healthcare with technology. Even Homer Simpson is in on the act (though not of his own free will). You can get a glimpse of that by clicking here to get to the video on the Forbes Video Network. It's less than 3 minutes long.

Do you like what you see? Are they on to something or are they nuts? Send me your comments and share them with my other readers.

I will hold back with my own opinions until I've heard from you.

Update: Software for Clinical Development - 2010 Edition

The updating of this software list is still in progress. Several new software categories have been added and the list of vendors is growing and shrinking at the same time. In other words, some companies have gone out of business, others have been assimilated and new ones have also been born. At the moment, I am optimistic that the list will be ready to share sometime in November. Your patience is appreciated and hopefully rewarded fairly soon. 

Software for Clinical Development - 2009 Edition

Many of you have written to me over the past year that the MS Excel spreadsheet I created last year that listed software for clinical development was very useful.

Some people also wrote in that the list was by no means complete. Of course, they also told me which software packages were missing.

So, without further ado, here is an up-to-date list for 2009. Of course, I expect that several readers will again let me know that it's still not complete!

Download ClinDevSoftwareVendors-2009

Software for Clinical Development

Having recently particiapted in two DIA meetings, I thought it would be useful to pull together a spreadsheet of vendors offering software used in clinical development. This can serve as the basis for a more comprehensive list built and maintained by reader input.

For now, the list is kept in an Excel spreadsheet:

Download ClinDevSoftwareVendors-April2008.xls

Please note that I consider this spreadsheet as the intellectual property of The Laszlo Letter. In other words, it is copyrighted. You may use it as a reference document but not benefit from it in any financial manner or reproduce it without my permission.

To contribute new items or update those that already exist, just use the comment function of the blog. I will take it from there and post new versions of the spreadsheet as necessary.

Thanks in advance for your help.

Lilly: Implementing SAS Drug Development

Notes from the 23rd DIA CDM Conference

Susan Duke of GSK chaired a session on Tuesday, March 18th, called "Statistical Computing Environments: Collaboration through Metadata, People, Process and Software." During this session, Christopher Colangelo, Associate Senior Statistician, presented Eli Lilly's effort to implement SAS Drug Development (SDD) as a centralized but globally available repository for clinical data.

But first, and for those unfamiliar with this relatively new concept, a Statistical Computing Environment (SCE) is a combination of hardware, software and processes, that enable the collection, management, analysis, and transparency of operational data within a life sciences environment performed in compliance with government regulations and operating best practices. From a technical perspective, it is also an extension of a relatively new software category called "Clinical Data Repository" or CDR.

You can learn more about both SCE and CDR via the following posts on this web site:

• Clinical Data Repository (CDR) 101
• Clinical Data Repository (CDR) Vendors
• Of CDR, CDMS and EDC
• The EDC, CTMS, CDM Confusion
• DIA Reflections: The Importance of Semantics
• Genzyme: Biostatistics with Waban SCE

At Lilly, the selection of SDD arose from the recognition that internal staff in Data Management, Data Delivery, Statistics, Medical Communications and external partners such as CROs needed an environment that would allow for greater collaboration within a secure environment.

The "Lowedown" on Lab Notebooks

Rather than listening to me today, I want to draw your attention to a post by Derek Lowe who writes the "In The Pipeline" blog.

Derek is a chemist who works for a Biotech company in Cambridge, Massachusetts although you would not know that from his blog. That's because the blog is purely his own and is pleasantly and refreshingly biased. In other words, he expresses his own opinions and not those of his employer.

Recently, Derek got around to writing about Electronic Lab Notebooks (ELN), a topic that I have not spent much time discussing on this blog. However, lab automation is a critical component of both discovery and manufacturing and does deserve coverage.

So, if you're interested in this topic, go ahead and click on the hyperlink above. You'll get Derek's opinion about ELN software and as an added bonus, the opinions of over 30 other individuals who were moved to comment on it. And, you'll get to know a little bit about the vendors who provide such software and include IDBS, Cambridgesoft, Enso, Symyx, and EMSL.

Apple iPhone: Life Sciences applications needed. Money available.

As you know by now, I am betting that the Apple iPhone will become an important communication and collaboration tool in our industry. This, in spite of many dissenting voices that the iPhone is not ready to handle real business applications.

Apple has now reported that over 100,000 downloads have been made of its Software Development Kit (SDK) since its launch on March 6th, 2008.

Now, Kleiner Perkin Caufield & Byers (KPCB) has launched a $100 million fund to support the development of iPhone applications. According to its web site, the fund "will invest in companies building applications, services and components. Focus areas include location based services, social networking, mCommerce (including advertising and payments), communication, and entertainment. The iFund™ will back innovators pursuing transformative, high-impact ideas with an eye towards building independent durable companies atop the iPhone / iPod touch platform."

According to the FAQ on the KPCB web site, the funding can be anywhere betweek $100K and $15M. The application form can be found here.

So, this is a great opportunity for all you entrepreneurs out there to show how the iPhone can be leveraged to support the R&D, Sales & Marketing and/or Manufacturing & Logistics segments of our industry. Even if you don't end up being funded by KPCB, only $99 stands between you and the SDK.

First, think BIG! Then start coding.

DIA Euromeeting: Impressions and Recommendations

I’m writing this on the plane to New York from Barcelona having just attended the 2008 DIA Euromeeting. As a veteran of many DIA annual meetings in the USA, I must admit that this year’s Euromeeting was like a breath of fresh air. A key reason for this may be the calculated risk that the meeting planners took by redesigning the program around themes and sessions.

Suggestion: Click here to see a phenomenal set of Barcelona photos!