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Perceptive Informatics Upgrades TrialWorks CTMS, DataLabs EDC
Bio-IT World | Perceptive Informatics has just made some notable time-saving improvements to its specialized clinical trial management system, all of which were developed based on feedback from the software’s current roster of over 40 company users.
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Regulatory Changes Afoot in India
Bio-IT World | As part of its broader examination of the clinical research process within its borders, India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).
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CDISC and Partners to Train FDA Reviewers
Nov. 24, 2008 | The Clinical Data Interchange Standards Consortium (CDISC) was recently chosen by the FDA to provide training to FDA reviewers on a whole host of CDISC topics.
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Medidata Spurs Innovation with Developer Central
Bio-IT World | Medidata Solutions is launching Developer Central, an online community to support sponsors in their efforts to integrate various clinical trial solutions with Medidata Rave, the company’s electronic data capture and clinical data management platform.
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Kayentis Makes Push into North America with EDC Alternative
Bio-IT World | Kayentis, a provider of digital pen and paper technology for the clinical trial industry, is strengthening its U.S. presence with an infusion of $8.7 million in cash to hire new technical and sales staff and expand its offices in Philadelphia.
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DecisionView Brings Predictive Analytics to Recruitment
Bio-IT World | DecisionView has just released the latest version of StudyOptimizer, Web-based clinical trial software that helps study managers more intelligently craft recruitment and enrollment plans, spot problems early, and test potential solutions before taking corrective action. It quenches the industry’s “thirst for predictable performance” and on-time study completions, says CEO Steve Andrade.
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eCliniqua Briefs – Nov. 3, 2008
- Phase Forward reports third quarter 2008 results
- OmniComm Systems reports strong quarter
- C-TASC to manage clinical trial data for National Institutes of Child Health and Human Development
- TAKE Solutions updates PharmaReady submissions publications solutions
- Exco InTouch named runner-up for Most Innovative Recruitment Strategy
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eCliniqua Briefs - Oct. 27, 2008
Acurian Inc., a provider of patient recruitment solutions, has released version 4.0 of Recruitment Manager, its fully hosted, web based software platform that offers clinical trial managers real time patient recruitment and enrollment metrics to better manage recruitment campaigns and
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OpenClinica 2.5 Targets Industry-Sponsored Trials
Bio-IT World | With its mid-September release of OpenClinica 2.5, Cambridge, MA-based Akaza Research has given pharmaceutical companies reason to take heed of the open source movement.
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Trials Disclosure Clears Next FDAAA Deadline
Bio-IT World | The Food and Drug Administration Amendments Act (FDAAA), enacted last year, includes a three-year timeline of requirements furthering clinical trials reporting on the World Wide Web. September 27 was the deadline for the reporting of basic results on clinicaltrials.gov and it caused some “angst” among study sponsors, says Tim Bacon, CEO of Newtown, PA-based PeerView.
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10 Secrets to Recession-Proof Your Business
Read this white paper to discover 10 strategies smart companies deploy to recession-proof their business.
Leaders generally face hard choices on how to mange a company during an economic downturn and
behave in one of three ways:
1) “The ostrich” - Preserve the status quo/hope for the best
2) “The bull in the china shop” - Blindly cut expenses across the board
3) “The fox” - Use the downturn to make your business more effective and position it for future growth
Learn how to behave “like a fox” and use a recession as a means to pounce on emerging trends.
High-Performance Computing in Life Science & Education The varied collection of Bio-IT World articles and insights assembled in this BriefingON examine key trends in HPC infrastructure and how researchers are putting their best computational resources to use. Provided here are stories and lessons around the effective use of high performance computing in life science. Download the BriefingON.
Software Helps Doping Control Lab Streamline Results Management The Karolinska University Hospital’s Doping Control Lab tests thousands of samples annually for stimulants, diuretics, and other masking agents. Increased regulatory pressure and new technologies increased the number of samples analyzed creating data management challenges. Waters® NuGenesis® Scientific Data Management System and TargetLynx™ Application Manager software were used to reduce the time required to calculate, review and search results.
Medidata Solutions
Rising Clinical Trial Delays and Costs - Addressing the Cause, Not the Symptoms
 Protocol complexity is taking a toll on clinical study speed and efficiency: increasingly complicated and ambitious protocols are not only burdening sites and study volunteers but are also prolonging trials and increasing expenses. In response, sponsors have turned to global study placement, restructured site relationships and new site management practices, but the problem remains.
This podcast will discuss:
- Why these responses address only the symptoms, not the underlying cause, of rising clinical trial delays and costs.
- Results of a recent joint Tufts University / Medidata Solutions study.
- New metrics benchmarking protocol design trends.
- Systematic protocol design improvements and why they are essential to clinical trial performance excellence.
Speakers: Ken Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development, and Ed Seguine, General Manager, Trial Planning Solutions at Medidata.
Download Now
More Podcasts
Director, Center For Information Technology (CIT) - National Institutes of Health (NIH), Department of Health and Human Service
Located in Bethesda, MD. This position requires:
• High-level vision, leadership, management, and modernization of CIT programs and services.
• Strategic direction and policy development for CIT long-term operations and objectives.
• Serve as a key IT advisor to the NIH Chief Information Officer.
A TOP SECRET security clearance will be required. More job detail is found at: http://www.jobs.nih.gov under the Executive Jobs section.Or contact Ms.Winnie Garner at seniorre@od.nih.gov. Applications must be received ELECTRONICALLY by (11:59 p.m.), December 17, 2008. DHHS and NIH are Equal Opportunity Employers Bioinformatics Manager- Lilly Singapore Centre for Drug Discovery
For more information click here
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