The Laszlo Letter

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.

Sharing Clinical Data through Application Integration

Notes from the 23^rd DIA CDM conference

While I’m not enamored of attending conference sessions that start at 8:30 in the morning, I was glad that I made it to the Tuesday morning session on “Accessing Clinical Trial Management Information from eClinical Systems and Capabilities” chaired by Paul Bleicher of Phase Forward.

Before I jump into the details, I want to warn you that the words “clinical trial management information” in the title of the session can be misleading. This is because of a key learning that I took away from this session. In short, when we begin to effectively extract and use data and metadata from all of the transactional systems at our disposal, they become (in aggregate) a comprehensive clinical trial management environment. In other words, we no longer need a CTMS because we have achieved a CTME(nvironment).

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!

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.

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...

Data analysis and visualization with Tableau

While the statement "If it ain't broke, don't fix it" serves as a great warning whenever we contemplate something new, it should not mean that we ignore the options. A good case in point is the way we currently analyze and visualize discovery and development data.

The tried and true tools include SAS, S-PLUS, Spotfire and Integrated Review. But now there is another tool that's worth a look, Tableau.

Genzyme: Biostatistics with Waban SCE

A few posts ago you heard me rant about the inexplicable secrecy that tends to surround large biopharma IT projects. So, it's with great pleasure that I can report that not all biopharma companies wish to keep everything to themselves.

Specifically, I want to draw your attention to a recent article in eCliniqua and Bio-IT World related to Genzyme's implementation and use of the Waban Statistical Computing Environment (SCE.)

As you will learn from the article, “Waban offers a completely controlled environment where everything done to data is audit-trailed, including when information gets handed off from clinical data management to biostatistics and from biostatisticians to medical writers,” says Dana Soloff (Genzyme’s director of statistical programming.)

Apple iPhone for EDC and CTM

As a person who regularly sticks his neck out with the ever present danger that it may get cut off, I was pleasantly surprised today by an announcement from Nextrials. Specifically, Nextrials made the announcement that its Prism clinical trials management (CTM) and electronic data capture (EDC) platform is now accessible via the Apple iPhone.

In this particular case, Nextrials is agreeing with me that the iPhone does have a place in the corporate setting. In prior posts, I talked about the use of the iPhone for sales force automation (SFA) and discussed why the jury is out whether this phone can succeed in the business world.

Now, Nextrials is showing that the iPhone can also help run and manage clinical trials.