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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

On the Data Analysis front, more solutions like 'R' are either taking on or complementing SAS. Then there are tools that allow better visualization of data such as Spotfire, iReview and QlikView.

While Regulatory Affairs has always been at the forefront of technology adoption, it's not until now that viable solutions exist to help with the tracking of regulatory commitments. Take care though, this category is still emerging with several vendors taking different approaches to the problem. It will still take several years for the base set of features to gel (i.e. become standardized).

A lot has happened on the CDW/CDR/SCE front since last year. The most significant is the wider adoption of this techology as the replacement for CDM. Another key development was the acquisition of Waban Software by Phase Forward which was then quickly snapped up by Oracle. Thus, you now have two solutions from a single vendor. It will be interesting to see how things develop on this front. Will Oracle become the dominant player? Will SAS do something bold or stay an also-ran? Will a new vendor come along and disrupt the market?

Patient recruitment remains a huge problem for the industry. Without the internet and the rise of smart phones and PDA's we would not be seeing much movement here. Perhaps the most important development is the widening use of social networking to both identify and entice patients to become trial subjects. A word of caution is also needed here: Technology will not by itself lead to a good solution.

While there are many more things to be said about this list, I will reserve that to future posts. For now, please feel to use the list as you see fit. Note, however, that the worksheets are password protected to prevent you from modifying the data that we have painstakingly developed. If you want to slice and dice the data, you will need to copy them to another spreadsheet or worksheet.

I hope that you will find the list useful. As always, I look forward to your comments and updates.












Clinical Laboratory Science

I like the idea of using social media to bring in more people. Maybe a viral facebook campaign would see good results.

Kristopher Gawron

Hmmm... it's great that a number of Data Analysis software are surfacing these days. This type of software can help organize a data storage system. This is a very interesting post, by the way.

Michael Braun

Dear George,
Thanks for this interesting post. Maybe you should suggest adding the eCTD Office people?

Best regards,

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