Seeking 3+ article cites/case studies regarding Major Pharmaceutical
organization Clinical Drug Development Delay due to mismatch between
Available ("Clinical") vs. Required ("Project Management") Clinical
Team member skills: Observation, diagnosis and remediation internally
and/or by management consulting organizations.

---

Request for Question Clarification by pafalafa-ga on 24 Sep 2005 19:40 PDT

Frank,

Here's one article that touches (albeit lightly) on the topic at hand:


http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=96582


Is this close to what you need, or are you interested more in an
academic-style research paper?


pafalafa-ga

---

Clarification of Question by frankkilpatrick-ga on 25 Sep 2005 13:54 PDT

Yes, this article is a start. Yet it is too simplistic: More a ?tip sheet.?

What I'm looking for is a "case study" documenting the impact (or not)
of the introduction of more pragmatic methods (perhaps through a reorg
that installs differentially-experienced managers) and the results
realized. It needs to show actual implementation of a (pharma/biotech
industry) clinical trial operational system process improvement model.
But whether it is a popular article, an academic paper, a scholarly
journal piece or in HBR doesn?t matter.

Thank you, Frank

---

Request for Question Clarification by pafalafa-ga on 28 Sep 2005 04:44 PDT

Frank,

Is this one getting any closer?


http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=83567

---

Clarification of Question by frankkilpatrick-ga on 28 Sep 2005 14:28 PDT

Yes, it?s close in that it provides the theoretical POV we?re seeking.
However, since it covers EDC, it?s not a perfect match. Also, it would
be helpful if the research provided a ?case study? of the management
skills development process that moved a pharmceutical development
organization from the typical clinical operations style to
other-industry accountability-based project administration model -
with associated outcomes ? rather than a ?forecast? essay. Thanks,
Frank

---

Request for Question Clarification by pafalafa-ga on 30 Sep 2005 05:02 PDT

Frank,

Making some progress!

This article from the FDA:


http://www.fda.gov/fdac/features/2000/500_gene.html


highlights a number of highly-publicized clinical trials that ran into
real problems.

Are these the sorts of example clinical trials you had in mind?  If
so, I can probably track down more detailed reports on what went
wrong, on on the steps made to fix things.

I just wanted to check in, though, to see if these are on target for you...


paf

Hello frankkilpatrick-ga,

Along with pafalafa-ga, I too have been researching your question. I?m
shocked at how difficult it is to find illustrative case studies,
articles or papers to discuss current trends in the changes taking
place in clinical trial management. I trust that the ones I?ve found
will meet your needs. Please don?t hesitate to ask for clarification.

Wishing you well for your research.

~ czh ~


http://www.acrpnet.org/resources/whitepapers/03whitepaper.pdf
2003 ACRP White Paper
Tipping the Scale Toward Success (PDF)

Authors James Maloy et al. explain, "... in order for an idea to take
off, or 'tip,' it must be contagious; that small incremental causes
can lead to big effects; and that change happens in one dramatic
moment." ACRP's Future Trends Committee "Tipping Point" contest
received 52 entries from which five winners were given cash awards and
whose fresh ideas for improving the clinical trials process are
summarized here. (Reprints not available)

***** This is a 21 page white paper that discusses many new approaches
to clinical trial management with specific examples of products,
technologies, procedures and methods that go beyond EDC.

-------------------------------------------------


http://www.researchpractice.com
http://www.researchpractice.com/rp_archive.shtml
http://www.researchpractice.com/rp_cumulative.shtml
Research Practitioner

***** You can browse past articles for topics that might be of
interest and purchase them individually or it might be worth it to
subscribe to get unlimited access.

------------------------

http://www.researchpractice.com/archive/RP46QArevision.pdf
Quality time: The art of QA program development for research sites
Full Article
November/December 2003

***** This is a 7-page article that discusses pragmatic approaches to
process improvements in clinical trials.

-------------------------------------------------


http://www.transenda.com/news.asp?xcyte517
XCYTE THERAPIES CHOOSES TRANSENDA TO DEPLOY PATIENT TREATMENT
SCHEDULING APPLICATION
BELLEVUE, WA - May 12, 2005

Solution automates shared calendar for Xcyte departments
TranSenda International, LLC announced today that it has deployed a
patient treatment scheduling solution at Xcyte Therapies, Inc. that
gives Xcyte's clinical, manufacturing, quality assurance, quality
control and material control departments access to a shared master
calendar for managing the clinical trial logistics required for
manufacturing of a patient-specific investigational agent.

***** This is a short article that discusses the implementation of a
Clinical Trial Process Manager product.

------------------------

http://eai.ittoolbox.com/documents/document.asp?i=3549
http://www.transenda.com/assets/WP_BPM_Clinical_Trials.pdf
White Paper: Business Process Management and the Clinical Trial Process
4/12/2005 4:40:10 PM
By TranSenda for TranSenda

Summary: 
This white paper explores many of the issues faced by both small and
large life sciences companies when attempting to apply technology to
the clinical trial process. It introduces the concept of BPM and how
this technology differs from traditional software applications.

-------------------------------------------------


http://www.wfmc.org/information/eip2.htm
Excellence in Practice, Innovation and Excellence in Workflow and
Imaging, Volume II
The Case Studies

Janssen Research Foundation (Titusville, NJ) uses imaging and workflow
to manage case report forms (CRFs) to reduce drug development time,
specifically the clinical trial execution process, which involves
final data collection, verification and data entry. Nominating vendor
is Universal Systems Inc., Chantilly, VA. Merit Award: Imaging, North
America

------------------------

http://www.e-workflow.org/downloads/hea-jan.pdf
JANSSEN RESEARCH FOUNDATION TITUSVILLE, NEW JERSEY

***** This is a 16-page write-up of an award-winning document workflow
implementation to improve a clinical trial process.

-------------------------------------------------


http://www.campbellalliance.com/articles/White_Paper-Global_eDM_Implementation_FINAL.pdf
Critical Success Factors in the Global Implementation of Electronic Data Management
White Paper

According to the most recent benchmarking document from the EDM Forum,
70% of eDM initiatives fail to achieve expected benefits.

------------------------

http://www.eclinicalforum.com/frameknowledge.htm
EDC Metrics Survey 2004
Available:  	Jun 2004	
Price:	 Free 
Download Report -- 714k zip ? 30 pages

The eClinical Forum has recently conducted a internal survey of
companies involved in conducting EDC trials to assess the feasibility
of establishing standard metrics for the assessment of EDC
performance.

***** Some of these articles might be useful for evaluating current
directions in electronic initiatives in clinical trial
implementations.

-------------------------------------------------


http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=166546
Entering the Realm of Flexible Clinical Trials

Based on the numbers, sponsors will rapidly change their clinical
trials midstream.Jun 1, 2005
By: Kenneth A. Getz 

The business community has long held that performance can only really
be managed when it can be measured. Clinical research sponsors have
been embracing this concept for decades. But during the past five
years, research sponsors have significantly increased the
sophistication of--and their usage of--metrics.

***** This article addresses current trends in clinical trials.

-------------------------------------------------


http://www.oracle.com/industries/life_sciences/IDC_CTMS.pdf
U.S. Clinical Trial Management Systems 2004 Vendor Analysis:
Leadership Grid and Market Shares

------------------------

HTTP://WWW.GII.CO.JP/ENGLISH/ID25338_TRIAL_MANAGEMENT.HTML
U.S. Clinical Trial Management Systems 2004 Vendor Analysis:
Leadership Grid and Market Shares
Pub Time: 2004/11

Abstract
This Life Science Insights study discusses the expected strong growth
in the clinical trial management system (CTMS) market beginning in
2004 and accelerating in the 2005-2007 period and beyond. The market
for CTMS is still relatively immature, and while existing vendors
continue to make progress, the industry still lacks a comprehensive
vendor-supplied package for clinical trial management. According to
Life Science Insights analyst Judy Hanover, "Current market leaders
cannot afford to become complacent as this market evolves; leadership
and market share positions remain in flux." This document considers
the competitive positioning and potential for market leadership of
selected CTMS vendors, identifying those best positioned to gain
market share during this growth period.

[Report]
U.S. Clinical Trial Management Systems 2004 Vendor Analysis:
Leadership Grid and Market Shares
Pub Time: 2004/11 
Published by : IDC #32166
Distributed by : Global Information, Inc. 
Price 
US $ 2500.00 (PDF by E-mail (Single User License)) 
Authors: 	Judy Hanover, Ellen H. Julian
Document Type	Market Analysis
Number of Pages     	19
Number of Figures     	2

***** The entire report is available at this site. It might be of
interest to you since it lists the current players in the clinical
trial management systems field.


===============
SEARCH STRATEGY
===============

implementation results  "clinical trial" operational system process improvement
"case studies" "clinical trial management"
pharmaceutical development organization "project management"
performance metrics case study