The Laszlo Letter

Roche to implement Google Apps for 90,000 employees

You are probably aware by now that Roche has made a deal to roll out Google Apps on a global basis. This was reported by many news organizations and bloggers. One that is quite interesting, however, is on ZDNet since it generated quite a bit of heated discussion.

The rationale for this important move has to do with interoperability issues, or lack thereof, between the two solutions used previously by Roche and Genentech. This is stated by Roche CIO, Alan Hippe, on Google's Official Enterprise blog.

Reactions to the announcement focused on three issues:

1. Data Security

2. Data Privacy

3. Usability

In particular, comments pointed out security flaws in Google Apps, the probability that Google would inappropriately mine the Roche data/documents for their own purposes, and that users would get a much weaker set of email and MS Office-like functions.

These concerns may be real but also show that the commentators do not know how Roche operates. First, nothing at Roche is done in haste or without due diligence. The type of questions raised by those reacting to a press release would have already been studied to death by Roche staff and made available to senior management including risk, QA, procurement and legal staff. The decision would not have been made without Google agreeing to a detailed set of system requirements and the contract no doubt contains an equally strong Service Level Agreement (SLA). There would also be strict controls on privacy and security including what Google could or could not do with the data. Indeed, it is likely that the only thing Google will be able to do with Roche data is to provide appropriate technical support. And yes, it is also likely that an agreement is in place to govern how data moves (or not) between borders.

Then there is the rollout. Although I have worked quite closely with Roche IT on application implementations in the past, I am not privy to the way Google Apps will be rolled out. What I can predict is that it won't be done on a one-shot basis. One probable scenario (given what Dr. Hippe has stated) is for the email and calendaring functions to be rolled out first and even that in a phased manner to the 140 countries where Roche operates. It will probably start with the USA and Switzerland, then the UK, followed by the rest of Europe. Other regions would follow with double-bite countries like Japan going last.

You can then expect word processing, presentation and spreadsheet functions to follow. However, I would be willing to bet that other collaboration features (e.g. blogging, social networking) may come out before or in parallel with the more traditional office functions.

Although Roche and Google maintained radio silence on the current systems, it does not take a genious to see that Microsoft is in jeopardy at Roche. Given that this industry tends to follow the leader, Microsoft may suffer the fate of Blackberry in the biopharma sector. You may be elated or deflated by the prospect.

IT Trends for 2012 by SAFE-BioPharma

The following was recently released by the SAFE-BioPharma Association. Although the IT trends they cite may be on the adoption curve, it is not clear how long the adoption will take. As with almost anything in our industry, don't expect it to happen overnight.

THREE MAJOR IT TRENDS WILL SHAPE LIFE SCIENCES IN 2012

Fort Lee, NJ (January 19, 2012) -- Three trends will shape the life sciences in 2012, according to an analysis by SAFE-BioPharma Association. They are the expanded use of standards-based interoperable digital identities, cloud computing in clinical trials, and the use of electronic trial master files for clinical trial management.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies [broken sentence]

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures.

3. ELECTRONIC TRIAL MASTER FILES

“Trial Master Files – the central record containing the files associated with clinical trials – are one of the last areas where clinical development records are primarily paper-based,” explains Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association, Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org.

Change of Direction for 2012

As you all know, the focus of this web site has been on leveraging information technology in the service of R&D. While there is plenty to talk about on this topic, I have been getting more and more frustrated with other aspects of our industry. Specifically, I am extremely upset and frustrated with politicians, pundits, corporate executives and (sometimes) mere employees who are actively undermining and possibly trying to destroy one of the most successful and useful industries on the planet. So, in 2012 you will be subjected to my opinions on any topic/issue that I feel may undermine the continued success of the biopharma sector. Of course, I will still talk about IT matters.

So, get ready!

As a line in one of my favorite movies goes: I'm mad as hell and I'm not going to take it anymore.

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

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. 

Electronic Health Records (EHR) coverage at HIMSS

The annual meeting of the Healthcare Information and Management Systems Society (HIMSS) took place last week in Chicago. While there are many publications out there covering this meeting, ChannelWeb had an especially good series of articles on it.

Those of you who are not yet familiar with ChannelWeb, it is a web site focusing on companies that sell computer and communication based solutions (i.e. hardware and software.) In other words, the sellers ARE the channel.

As you will see from these articles, the most popular topic at HIMSS was the Obama stimulus package and its implications for health care. As you can imagine, vendors had a Pavlovian reaction about the potential to make a lot of money.

How well the money will be spent remains an open item. Once thing is certain. A lot of it will be wasted.

Read on...

HIMSS: Moving From Stimulus Hope To Real Health-Care IT Projects
ChannelWeb , April 10, 2009
At HIMSS, VARs, CIOs and vendors look past the initial round of stimulus excitement to gauge what's coming next.

20 Scenes From HIMSS 2009
ChannelWeb , April 09, 2009
The annual HIMSS conference brought more than 27,000 attendees to McCormick Place in Chicago, to hear from each other and from the likes of Dennis Quaid and Alan Greenspan as they place their bets on the future of health care IT. A strong pulse? You bet--and Channelweb was there to check it.

HIMSS: Greenspan Says Economy 'Will Turn, But Not Yet'
ChannelWeb , April 08, 2009
At HIMSS, Alan Greenspan addresses technology's role in health care and the broader economy.

HIMSS: Dell, Perot Systems Unleash Health Care IT Salvo
ChannelWeb , April 06, 2009
Dell announces partnerships with Perot Systems and others and virtualization and social networking solutions for health care

HIMSS: Dennis Quaid Calls On Health-Care Modernization To Eliminate Errors
ChannelWeb , April 05, 2009
Actor Dennis Quaid said at HIMSS keynote that health-care IT technology is the only way to reduce medical errors.

HIMSS Preview: Health Care Tech Revs Up As Stimulus Begins
ChannelWeb , April 03, 2009
Electronic medical records and health care IT funding from the federal stimulus package are on everyone's minds as HIMSS gets under way in Chicago.

Health Care IT: 25 Solutions To Check Out At HIMSS
ChannelWeb , April 02, 2009
A sampling of products and solutions to see at the 2009 HIMSS Conference in Chicago.

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

Obama, Healthcare IT and the FDA

Today is day 2 of Obama's presidency.

While I do not expect him to even think about the FDA just yet, his inauguration led me to speculate about the possible changes that may come about for Healthcare IT in general and the FDA in particular. Somewhat coincidentally, these thoughts came out on inauguration day in the now weekly magazine Pharmaceutical Executive Europe. If you don't yet subscribe to this wholly electronic publication, consider doing so.

Click here to read the article which begins on Page 8. Your own thoughts on these topics are welcome.

Obama's Healthcare Team

Next week the USA gets a new President!

Anyone who is interested in what Obama will do with Healthcare should be interested in the colorful cast of characters that he has (and will) assembled to tackle this monster. One of them is Peter Orszag who will now be his budget director.

An Economist by training, Mr. Orszag already knows a thing or two about healthcare. He's got the facts on the spending front and has a few ideas about putting healthcare on a diet.

If you want to know more, there is plenty of that on the Internet. Here is one pretty good review (The Number Cruncher in Chief) about Mr. Orszag. Skim it first and then decide what parts you want to read.

Quotations from FDA CDER Head Janet Woodcock

Notes from the 23^rd DIA CDM conference

In the next few posts, it is my intention to share with you some of the information presented at the 23^rd DIA Clinical Data Management (CDM) conference. It is also my intention to give you some of my own thoughts about what I saw and heard.

The title of the conference was “Data Management in Transition: Putting the “e” in Data Management.” I am happy to report that the conference organizers did a great job keeping the majority of speakers focused on this topic. So, kudos are in order for Sue Dubman (Theravance), Kristin Neff (Boston Scientific), Paul Bleicher (Phase Forward), Shahla Farr (FDA), Rebecca Kush (CDISC), Denise DeRenzo Lacey (Waife & Associates), Johann Prove (Bayer Schering Pharma), Don Rosen (Rosen Consulting) and Steve Wilson (FDA.)

I could not think of a better approach to get things rolling than to simply convey several quotations from the talk given by the conference keynote speaker, Janet Woodcock MD, of FDA. As you may know, Dr. Woodcock was recently put in charge of CDER and she wasted no time telling us what she thought her division, and indeed all of FDA, should be doing.

These quotes nicely reinforce the tone of the CDM conference, one that was palpable if not always directly stated, namely that The time for change has arrived.

While I was initially tempted to put these quotes in context, I resisted that urge since they are as applicable to what we do in general as to the specific issues being discussed by Dr. Woodcock.

So, mull these over at your leisure and stay tuned for more about the meeting in future posts.

Quotations from Janet Woodcock

“current methods are not sustainable”

[there is] “almost a crisis in the United States to get clinical trials done”

“there is too much data being collected”

[we] “need to link EHR to clinical trials”

“we need to get out of the way we are doing things now”