eCliniqua - Innovative Management in Clinical Trials
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IN THIS ISSUE 
Investigator Shortage the Chief Challenge in India 
NIH Helps Scientists Sleuthing for Clues in the Human Genome 
Evado Tackles EDC Shortcomings 
 
 

Investigator Shortage the Chief Challenge in India
By Deborah Borfitz

Part 1 of this series  appeared in the Jan. 22 issue of eCliniqua.

Improvements to the airlines and IT infrastructure in India have allowed international clinical research organization (CRO) Quintiles to migrate from the country's metropolitan areas to smaller cities and towns where equally competent investigators can be found, says Ferzaan Engineer, CEO for Quintiles India. "We move investigators up the experience ladder by monitoring and mentoring them more intensely than we would in an established center." This has meant investments in training, on-site study coordinators, development of standard operating procedures, and, in some cases, physical infrastructure such as study rooms and computer facilities.

Oversight of clinical trials by the Drugs Controller General of India is "pretty similar" to that of the U.S. FDA, and staffing has been strengthened to deal with the growing number of applications for carrying out clinical trials in the country, says Engineer. Ethical guidelines have been published by the Indian Council of Medical Research.

The regulatory environment may soon get a complete overhaul. A proposal before the Indian cabinet would move the current, under-financed drug authority into a single, larger organization - modeled after the FDA -- that also incorporates other areas of drug development, such as bioequivalence testing, biotechnology, and genetic research.  Read more.

 
 

NIH Helps Scientists Sleuthing for Clues in the Human Genome
By Deborah Borfitz

The National Institutes of Health (NIH) is taking a leadership role in a new research approach that involves scanning the human genome looking for variations, or markers, that raise the risk of disease. Results of these genome-wide association studies (GWAS) are being posted in a database accessible to qualified researchers and will be used to come up with better detection, treatment, and prevention strategies, says Emily Harris, PhD, epidemiologist in the new Office of Population Genomics within the NIH's National Human Genome Research Institute.

Until completion of the Human Genome Project about five years ago, GWAS weren't even possible. The latest, whole-genome genotyping technology has now made them more financially feasible to carry out, says Harris.  Read more.

 

Evado Tackles EDC Shortcomings
By Deborah Borfitz

An established clinical products company in Melbourne, Australia, has developed its first piece of clinical trials software, which it says has a few advantages over the leading electronic data capture (EDC) vendors.

Last November, Evado was released by Invision IT Systems specifically to address the frustrations of researchers and the shortcomings of existing EDC systems. Evado is a "total management system" that does far more than capture data electronically, says CEO Jennie Anderson. It also has a repository for the uploading of images and other clinical documents, a built-in patient booking and tracking system, and can report on safety data in minutes. Read more.

 
 
 
 

LIFE SCIENCE JOBS

GNS Biotech - Software Engineer, User Interfaces and Visualization
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GNS Biotech - Software Engineer, Platform Development
The successful candidate will work closely with the algorithm development team to add newly developed algorithms into the production platform and the biological applications team to define and implement new functional requirements for the platform.  The candidate must be comfortable performing development on all aspects of the system, including the algorithms, data management and modeling, programmatic/scripting APIs, and user interface, as well as implementing automated tests for any of these components.  Major upcoming goals will be the optimization of algorithms to scale to larger computational problems and the development of infrastructure required for the application of the platform to different problem areas within biology.  The candidate will be responsible for design of new components and maintenance of existing platform code.  Must work fluidly with a fast moving, interdisciplinary team, have excellent communication skills and a passion for learning new science.  For more information please visit  http://www.gnsbiotech.com/careers/openings/


GNS Biotech - Computational Scientist, Discovery Biology
The successful candidate will reverse engineer models from large coherent data sets.  In addition, the 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.  The candidate will be comfortable handing millions of marker and molecular phenotype data points using database management systems and statistical scripting, and will show familiarity with data issues regarding major genotyping platforms and external database resources.  Must work fluidly with a fast moving, interdisciplinary team, have excellent communication skills and a passion for learning new science.  For more information please visit  http://www.gnsbiotech.com/careers/openings/

GNS Biotech - Computational Scientist, Biological Applications Candidates must have a combination of experience in the following areas: bioinformatics, microarray data analysis, algorithm development, statistics, machine learning, and network inference or reverse engineering methods.  Successful candidates will have a PhD (or be equivalently qualified) in Physics, Applied Mathematics, Computational Biology, Operations Research, or Engineering or have similar training thereof in the computational and biological sciences and 3+ years experience in the field.  Must work fluidly with a fast moving, interdisciplinary team, have excellent communication skills and a passion for learning new science.   For more information please visit  http://www.gnsbiotech.com/careers/openings/

Bio-Informatics Scientist -Van Andel Institute -  
opening at Van Andel Institute in Grand Rapids, Michigan.  Position supports collaborators using XB Bio-Integration Suite Software.  Qualified candidates will have Ph.D. in molecular biology or related discipline.  Two years post-doctoral training and experience in bioinformatics analysis of high throughput biological datasets. http://www.vai.org/employment/opportunities/881.

 

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

Software Engineer, Bioinformatician-  -ISB - Job #07-052
The Institute for Systems Biology’s (ISB)
 Computational Core seeks qualified candidates to join its growing bioinformatics team.  For a full description and application instructions, please visit http://www.systemsbiology.org/careers.  ISB is an M/F/D/EOE.
 
 

FEATURED EVENTS

The 1st Symposium on Protein Tomography, May 1,2008,Boston,MA
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TEPR 2008 - May 17-21, 2008
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Laboratory Informatics, March 25-April 3, 2008 San Francisco CA. 
IQPC’s 3rd Laboratory Informatics conference is timed to influence developments in a rapidly advancing field by bringing together the major users and providers in the broad field of laboratory informatics. The conference is targeted at decision makers, policy strategists, problem solvers, advisors, researchers and consultants in the fields of chemical and laboratory informatics.
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Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence
February 25-27, 2008, Philadelphia, PA.  At the 5th Lean Six Sigma for Pharmaceutical, Biotech and Medical Device Excellence we will bring you case studies that tackle the problems you are encountering, provide you with real-world solutions to your problems and introduce you to industry peers who have been able to overcome many of the challenges that Lean Six Sigma presents. 
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The Association for Laboratory Automation (ALA) presents LabAutomation 2008, January 26-30, in Palm Springs, CA. LabAutomation2008, the world’s largest conference and exhibition focused exclusively on the rapidly growing field of laboratory automation, brings together a diverse group of academicians, scientists, engineers, business leaders, post-docs and graduate students from around the globe. For more details clicks here


Best Practices Awards Program - April 29, 2008
Bio-IT World announces its 2008 Best Practices Awards Program and calls for entries. Established in 2003, this prestigious award program recognizes the innovative utilization of technology and business strategies to accelerate drug and clinical development and ultimately improve human health.
 Click here for complete details and submit your entry today!

MIT Advanced Study Program  - Register for Spring 2008
Put MIT to work for you. The MIT Advanced Study Program (ASP) is now accepting applications for the Spring 2008 term.  ASP provides full and part-time certificate programs to working professionals at any stage of their careers. The program includes a flexible curriculum of MIT courses designed around the goals of participants and their sponsors.  Visit our website to view participant profiles & comments, watch our program video, and find out if MIT is right for you. http://web.mit.edu/mitpep/go/asp08-bioit.html

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

 
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BEST PRACTICES AWARDS 2008

There is still time to submit a Best Practices Awards entry, as the deadline has been extended to January 31, 2008.  The Best Practices Awards Program recognizes teams for their innovation and excellence in the use of technology to advance drug discovery, development, biomedical research, and clinical research.  Take advantage of this opportunity to showcase your organization's efforts and to contribute to the industry's broader knowledge base. 

Click here for more information and to submit your entry today!

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How Effective Document Management Can Help Accelerate Time to Market
 

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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

India Becoming Favored Destination for Clinical Trials
Jan. 22, 2008

Qumas: eCTD Compliance Clock Is Ticking
Jan. 7, 2008


TGen Targets Cancer with Molecular Profiling Study
Dec. 24, 2007

Go to all archived issues

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                                Healthtech Media GroupPublished by Cambridge Healthtech Media Group, division of CHI, Copyright © 2007; 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. 
For reprints and/or copyright permission, please contact The YGS Group, 1808 Colonial Village Lane, Lancaster, PA 17601.  Phone: 717-399-1900, ext. 110. Email: becky.mullaney@theYGSgroup.com

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