The Laszlo Letter

All things considered about the Life Sciences Industry with a particular focus on information technology.

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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.

Friday, 24 February 2012 in 05 Industry Controversy, 10 Innovation & Creativity, 20 Best Practices, 40 Data and Content Mgmt., 42 Workflow & Process Management, 60 IT Infrastructure, 65 Application Hosting, 70 Ethics and Compliance, 72 Regulatory Affairs, 74 Legal and Government Relations | Permalink | Comments (1) | TrackBack (0)

Technorati Tags: Alan Hippe, Blackberry, calendaring, cloud computing, email, Genentech, Google, Google Apps, Google Docs, internet privacy, Laszlo Letter, Microsoft, MS Excel, MS Office, MS Powerpoint, MS Word, presentation, RIM, Roche, social networking, spreadsheet

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.

SoftwareChart2011 
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

Continue reading "Software for Clinical Development - 2011 Edition" »

Wednesday, 10 November 2010 in 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 72 Regulatory Affairs, 99 Vendors | Permalink | Comments (3) | TrackBack (0)

Technorati Tags: AE, biostatistics, CDISC, CDM, CDM, CDR, CDW, Clinical Development, Clinical Research, CTMS, data analysis, data management, data management, data models, document management, eCTD, EDC, EDMS, ePRO, IVRS, Laszlo Letter, patient recruitment, PIM, PV, regulatory affairs, Software, SPL, statistical analysis

Hidden Gold Nuggets: Pfizer's Progress in Drug Development

Pfizerlogo I continue to be amazed by the number of great articles that do not get enough exposure. The key reason is that they are trapped in specific publications that you may never see or even know exist.

I was reminded of this again when opening my latest copy of 'Pharmaceutical Outsourcing' magazine. In this October 2010 issue I ran across an article by Chris Hilton of Pfizer, giving a great summary of the work being done by its Development Operations group.

As you may imagine, a significant part of the article focuses on Pfizer's growing and greater reliance on outsourcing. For example, the article states that in the past 5 to 7 years, the number of internal staff performing such functions like monitoring, data management and clinical programming has dropped from about 3,000 to 400 [no, this is not a typo].

At the same time, the number of external colleagues has gone up from roughly 100 to 2,400, most working for a group of 20 CRO's.

Doing some simple math got me to conclude that the total number of workers has stayed about the same. Of course, I don't know what is really going on here and one would need to ask the author what is behind the numbers. For example, are more studies being done by fewer people? Did the types of work being done change in any significant way? To what extent are technologies used affecting staffing?

Some other interesting facts (gold nuggets) noted in the article are:

  • Year after year, the Last Patient Last Visit (LPLV) to Database Release time interval continues to drop
  • The number of days from database lock to final CSR has dropped from 200 to 80 days.
  • 1.2 databases are locked each day
  • Reduction in cycle times ranging from 39% to >60% in several trial processes like Clinical Study Report completion and Protocol Development

 It is not my intention to review the whole article here. The best would be for you to read the whole thing and learn about other practices at Pfizer such as Functional Service Provider use, Reverse Auction Process, Continuous Improvement, Optimized Monitoring and Lean Six Sigma.

Read It! You won't be disappointed.

 

Monday, 25 October 2010 in 10 Innovation & Creativity, 12 Case Studies, 20 Best Practices, 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 80 Outsourcing & Offshoring | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: clinical development, clinical trials, Continuous Improvement, CRO, drug development, Laszlo Letter, outsourcing, Pfizer, Six Sigma

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. 

Monday, 11 October 2010 in 35 Clinical Trials, 36 EMR/EHR, 40 Data and Content Mgmt., 42 Workflow & Process Management, 50 Lab Information Management, 55 RFID, 72 Regulatory Affairs, 99 Vendors | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: Biotechnology, Clinical research, Laszlo Letter, Life Sciences, Pharmaceuticals, R&D, software

DIA 4th Annual Clinical Forum - Lisbon - October 11-13, 2010

Logo2  
If you are in Lisbon next week, chances are that you will be there for this conference.

This note is just to let you know that I will be there and presenting on a panel related to Clinical Data Warehousing chaired by Peter Stokman of MSD. This will be a 90 minute session focusing on the practical aspects of implementing systems that manage and allow for the analysis of clinical data with full traceability and auditability.

The rest of the program looks great with no less than 40 topics covered over the three days. Check out the program here.

If you'd like to get together and chat about any topic of interest, just drop me a line at my email address.

See you there!

Monday, 04 October 2010 in 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: biostatistics, CDM, Clinical Data, data management, Data Warehousing, DIA, Laszlo Letter, SAS

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

Wednesday, 11 February 2009 in 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 72 Regulatory Affairs, 99 Vendors | Permalink | Comments (4) | TrackBack (0)

Technorati Tags: adverse events, AE, biostatistics, CDM, CDR, clinical development, clinical trials, CTMS, Drug Safety, eCTD, EDC, ePRO, labeling, R&D, regulatory affairs, SCE, Software, SPL

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.

Tuesday, 08 April 2008 in 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 45 Sales & Marketing, 50 Lab Information Management, 55 RFID, 99 Vendors | Permalink | Comments (6) | TrackBack (0)

Technorati Tags: clinical development, clinical trials, Laszlo Letter, R&D, software

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.

Continue reading "Lilly: Implementing SAS Drug Development" »

Monday, 31 March 2008 in 12 Case Studies, 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 99 Vendors | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: biostatistics, CDR, clinical research, data management, DIA, Laszlo Letter, SAS, SCE, statistics

Sharing Clinical Data through Application Integration

Notes from the 23rd 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).

Continue reading "Sharing Clinical Data through Application Integration" »

Friday, 21 March 2008 in 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 60 IT Infrastructure | Permalink | Comments (1) | TrackBack (0)

Technorati Tags: clinical trials, CTMS, data, Eclipse Professional Services, Eli Lilly, Laszlo Letter, metadata, operational data, PharmaNet, Phase Forward, status reporting

Apple iPhone: Life Sciences applications needed. Money available.

Iphonesdk 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.

Thursday, 13 March 2008 in 33 Discovery, 35 Clinical Trials, 40 Data and Content Mgmt., 42 Workflow & Process Management, 45 Sales & Marketing, 50 Lab Information Management, 99 Vendors | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: collaboration, communication, iPhone, Laszlo Letter, Life Sciences, mobile computing

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