eCliniqua - Innovative Management in Clinical Trials
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IN THIS ISSUE 
Medidata Moves 'Upstream' with Fast Track Acquisition 
Adaptive Clinical Trials: More Talk Than Action 
Commentary: Is Informed Consent as Ethical as It Could Be?
 
 
 

Exclusive: Medidata Moves 'Upstream' with Fast Track Acquisition
By Deborah Borfitz

Medidata Solutions has acquired Fast Track Systems Inc., developer Tarek Sherifof the first protocol-authoring tool certified by the Clinical Data Interchange Standards Consortium (CDISC), eCliniqua learned during an exclusive interview with company representatives last week. The move will drive efficiencies across the clinical research process and further solidify Medidata's position as leader in electronic data capture (EDC) technology, says CEO Tarek Sherif.

The acquisition evolved out of a partnership between the companies that started early last year. The two organizations have a lot of "core similarities" in terms of their goals and approaches to improving the conduct of clinical research, says Sherif, including a relentless drive for efficiencies through standardization and innovative technologies. With Fast Track products in its portfolio, Medidata can accomplish that mission more broadly in terms of protocol development and trial planning, contracting, and negotiations.

Fast Track received CDISC certification last year for its first-of-its-kind structured protocol-design tool. Even on a standalone basis, the application - currently in use by several large pharmaceutical companies - "eases the study start-up process," says Ed Seguine, Medidata's new general manager of trial planning solutions (previously CEO of Fast Track Systems). The application captures key concepts and the relationships among those concepts - i.e. "the linkage of study objectives to outcomes to specific tasks, variables, and the analyses being performed" - and uses that information to help generate a protocol document. Read more.

 
 

Adaptive Clinical Trials: More Talk Than Action
By Deborah Borfitz

Lack of regulatory guidance may be the main, if not the only, barrier to widespread adoption of adaptively designed clinical trials across study phases.

The statistical and technological know-how necessary to conduct Jay Hersonadaptive clinical trials (ACTs) already exists. PC-compatible, open-source software known as WinBUGS accommodates the Bayesian statistical method with which ACTs have become more or less synonymous, says Jay Herson, PhD, senior associate in biostatistics at Johns Hopkins University. Simulation technology using programming language R also exists so companies doing ACTs can adequately plan for a multiplicity of possible sample sizes, outcomes, and resource consumption scenarios. Read more.

 


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EXPERT COMMENTARY 

Is Informed Consent as Ethical as It Could Be?
By Karl E. Peace
Jiann-Ping Hsu College of Public Health,
Georgia Southern University

The article New England IRB on Ethical Issues in Recruiting Patients, in the March 3, 2008, issue of eCliniqua served as a reminder to those involved with the execution of clinical trials of the importance of exercising due diligence to ensure that all aspects of clinical trial conduct are ethical.

I would like to bring to the attention of readers of eCliniqua some of my thoughts about making the informed consent process more ethical (see refs. 1, 2, and 3).  Many are aware, particularly in Phase III confirmatory proof of efficacy trials, that the determination of sample size carries with it an efficacy imperative.  That is, in order to confirm a question regarding efficacy of a compound, it is imperative that the sample size of the trial be large enough to provide a priori a high probability (large power) that the question will be answered. 

Sample size determination carries with it an ethical imperative as well.  Before I would agree to participate in a clinical trial, I would want to know first: that the trial was needed to answer a medically important question (and what that question was), and second: what the likelihood was -- for the number of planned participants -- that the question would be answered.  Including this second issue in the informed consent document in the protocol, would, I believe, make the informed consent process more ethical.  Read more.

 
 
 

LIFE SCIENCE JOBS

Lilly Singapore Center for Drug Discovery (LSCDD) - Associate Director of Informatics,
Lead and mentor a strong team for the Bioinformatics group at the Integrative Computational Sciences (ICS) department at LSCDD towards the development of novel algorithms, data analysis methods and software tools for drug discovery. Work closely with the Software Engineering group at ICS, and collaborate with the Discovery IT organization in Europe and USA. For additional information, or to apply visit: LSCDD


Lilly Singapore Center for Drug Discovery (LSCDD)- Senior Bioinformatics Scientist,Contribute to the development of novel algorithms, data analysis methods and software tools for drug discovery as part of the Integrative Computational Sciences (ICS) department at LSCDD.  Work closely with informatics and software engineering peers at ICS, and collaborate with the Discovery IT organization in Europe and USA.  The successful candidate will offer hands-on insight and expertise in tailored therapeutic informatics and statistical analyses at the post genomic era. For additional information, or to apply visit:LSCDD   


Lilly Singapore Center for Drug Discovery
(LSCDD) -Senior Software Engineer,
Join a strong team of software engineers in our Integrative Computational Sciences (ICS) at LSCDD. Collaborate with, and help develop integrated applications to process and visualize data from cutting-edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. The Software Engineering team provides computational tools and tailored software solutions that enable the global effort of Tailored Therapeutics; ‘The Right Drug, at The Right Dose for The Right Patient at The Right Time'. For additional information, or to apply visit: LSCDD 
 

Agilent Technologies-Asia Pacific - Job Requisition: 2021927
Job Title :   Application Engineer and Implementation Specialist for Lab Informatics Platform
Location(s) :  Bangalore, India.  Project management: small to large scale implementations, including integration/ validation of Agilent’s software platform.  Manage assigned customer account relationship, customer satisfaction and education of future Agilent plans.  On time and on budget implementation, focus Pharma, Petro and Chemical markets.  Qualifications:  BS/’MS Degree in Computer Engineering, or other related discipline or equivalent. Apply 

Agilent Technologies-Asia Pacific - Job Requisition:2021658, Job Title : Product Specialist – Laboratory Informatics Location(s) :  Bangalore, India.  Proactively understand customer needs and identify solutions to actively create business opportunities.  Manage a complex, enterprise solution sale with long sales cycle.  Develop approaches to achieve quota strategies.  Lead coordinated projects across organizations.  Solve complex broad range of problems.  Qualifications:  BS/MS Degree in Sciences, Engineering, Computer or equivalent plus 5 to 8 years work experience.Apply 

GNS Biotech - Computational Scientist, Discovery Biology 
Candidate will reverse engineer models from large coherent data sets.  In addition, candidate will complete genome-wide association analysis of disease and drug-response and develop methods to deal with population genetic structure, pedigrees, missing data and computational scaling.
 http://www.gnsbiotech.com/careers/openings/

More Life Science Jobs - Add a Job Listing 

 

FEATURED EVENTS

IIR - 12th Annual EDC & Beyond, April 14-16, 2008, Las Vegas, NV

InforSense Translational Research Symposium, May 2,2008, Boston, MA 

The First International Workshop on Label-free biosensing  April  8-9, 2008,  Enschede, The Netherlands 

BioInformatics Asia 2008, April 14-17, Singapore,

The Post-Approval Summit  May 14-15, 2008, The Conference Center, Harvard Medical School, Boston, MA 

The 1st Symposium on Protein Tomography -- May 1, 2008, Boston, MA

Med-e-Tel, The International Educational and Networking Forum for eHealth, Telemedicine and Health ICT, 16-18 April in Luxembourg. 

TEPR 2008 -- May 17-21, 2008 Ft. Lauderdale,FL 

Laboratory Informatics -- March 25-April 3, 2008, San Francisco CA.

Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence -- February 25-27, 2008, Philadelphia, PA.

Best Practices Awards Program -- April 29, 2008, Boston, MA 

MIT Professional Institute – 2008 Short Courses, Cambridge,MA 

GOT Summit: Getting Optimized Tools for Diagnostics - May 19-21, 2008, Boston,MA

Health 3.0 Summit, May 4-7, 2008, Las Vegas, NV

The World Congress Leadership Summit on Consumer Connectivity, May 6th, Boston, MA 

To have your event featured here, contact Lynn Cloonan for more information.

 
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BRIEFS

Phase Forward announced the Empirica Trace product, a significant new release of the company's adverse event reporting software, formerly known as Clintrace. With this new branding convention, Phase Forward is unifying its safety products under a new product family name - Empirica - for its suite of pharmacovigilance and risk management products. The Empirica Trace software provides a single, powerful solution that helps organizations collect, code, analyze and report adverse events to meet global regulatory reporting requirements. The product's streamlined Web-based architecture enables rapid deployment to multiple browser-based clients and helps minimize operations and support costs. Read the press release.

CRF Inc. announced that its TrialMax suite of ePRO software solutions will support Tablet PCs running the Microsoft Windows Vista operating system. Tablet PC-based eDiaries will be easier to use for many patient populations and will enable complex, site-based questionnaires to be administered electronically.  They will provide investigators the ability to obtain better data, by designing comprehensive patient questionnaires that take advantage of the Tablet's larger display area and the stylus or touch screen flexibility for more natural information entry and navigation ease. Read the press release.

ProTrials Research Inc. announced that the Women's Business Enterprise National Council (WBENC) has certified the company as a woman-owned business. WBENC is the nation's largest third-party certifier of its type and a leading advocate of women entrepreneurs as suppliers to corporate America.  "To earn this designation, a business must go through a rigorous and stringent certification process that, upon completion, gives it the opportunity to be considered for  projects or contracts that specifically encourage diversity, particularly within the government at the local, state and federal levels," said Linda Denny, president and CEO of WBENC, in a statement. Website: www2.protrials.com.

Health Level Seven Inc.(HL7) and The Clinical Data Interchange Standards Consortium (CDISC) have renewed their associate charter agreement, which was initiated in 2001. As a new key objective of the renewed agreement, HL7 and CDISC will develop joint educational programs in areas around the world. A half-day CDISC-HL7 tutorial titled "Harmonizing Standards Initiatives: An Overview of Collaborative Standards
Initiatives for Clinical Research and Healthcare" will be offered in Copenhagen, Denmark in April, as well as other regions of the globe throughout the year. CDISC and HL7 are also exploring holding a one-day joint event "Improving Patient Safety and Clinical Researchthrough Standards" in China and India in the fall. Read the press release.

FEATURED CONTENT

SGI's Meeting Today’s Computational Needs for Science

The quest to better understand disease mechanisms and find new treatments is driven by new laboratory technologies and ever-more sophisticated modeling and simulation efforts. As such, life sciences R&D investigations increasingly are relying on more powerful computing resources. The challenge is how to accommodate the broad mix of applications.
Addressing this issue, this paper produced by the Bio-IT World Custom Publishing Group discusses a new SGI Hybrid Computing Environment approach. It optimally uses shared memory systems, multi-processor clusters, and FPGAs to accelerate computational workflows. Download This Free Paper 



SGI's Supercharging Proteomics Discovery
The deeper study of proteins and their interactions can reveal scientific information once considered nearly untouchable to scientists and researchers. Today, unprecedented advancements in computing power are enabling the creation of mounds of proteomic based data along with the accompanying bottlenecks data can create.  Rather than just “simplify the experiment” to fit the computational resources an alternative is now available with the SGI Proteomics Appliance. This complimentary white paper, produced by the Bio-IT World Custom Publishing Group, looks at ways to use the Proteomic Appliance to handle the most intensive proteomics computing tasks facing science today. Download This Free Paper



Waters
NuGenesis SDMS: Improving Data Accessibility and Intellectual Property Managment 

Global pharmaceutical company improves the accessibility and intellectual property management
of drug candidate data with Waters® NuGenesis® SDMS software. Download the case study.Download Now!

To have your white paper featured here, contact Lynn Cloonan for more information.
EXCLUSIVE WEBCAST

NEW! Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group

Life Science Webcasts

Bio-IT World proudly introduces Life Science Webcasts -- a series of informal conversations with leading researchers and executives in the bio-IT and biopharma arena. This week, Dr. Jerald Schindler (VP, late stage clinical development statistics, Merck) discusses e-clinical research with Bio-IT World's Kevin Davies.

View the Webcast Now

Contact the Editors
Deborah BorfitzContributing Editor Deborah Borfitz covers development planning and protocol design; investigative site selection and management; and patient recruitment and retention.

Contributing Editor Ann Neuer covers project management, operations, and outsourcing, as well as data collection, data management, and electronic data capture. Ann has been writing in the clinical trials sector since 1995.

Web Editor Catherine Varmazis
manages and produces eCliniqua.
eCliniqua Archives


Clinical Trial Supply Chain Needs Improvement - Study
March 3, 2008

MIT Study Quantifies Globalization Trends
Feb. 25, 2008

China's SFDA Commits to Regulatory Transparency
Feb. 19, 2008

More Archives

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                                Healthtech Media GroupPublished by Cambridge Healthtech Media Group, division of CHI, Copyright © 2008; All rights reserved. eCliniqua may not be reproduced, electronically or in print, by any means, mechanical or electronic, in whole or in part, without written permission of Cambridge Healthtech Media Group, 250 First Ave., Suite 300, Needham, MA, 02494. 
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