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Bio-IT World
September 2006
Wayne R. Kubick |
Data Standards: Are We at the Tipping Point? A decade ago, the prospect of defining standards for representing clinical data was deemed impossible by many in the drug discovery industry, yet a large number of standards-related activities are rapidly converging. So, are we nearing a tipping point? Let's look at the evidence.   |
Bio-IT World
August 2005
Ellen H. Julian |
Tech Expertise Singles Out Outsourcers Biopharmaceutical companies are flocking to consultants, outsourcers, and staffing firms to help with discrete clinical trial processes to gain access to advanced technologies and reduce the drain on already-scarce IT resources. |
Bio-IT World
July 2005
Mark D. Uehling |
'E-source' Is Coming, Experts Say The odd marriages of the ancient and modern in clinical technologies were in evidence at the E-Clinical Trials & Research conference program. There was evidence of the adoption of advanced and robust commercial software -- even toward clinical trials that do not use paper, though most do. |
Bio-IT World
September 2005
Mark D. Uehling |
Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable. |
Pharmaceutical Executive
June 1, 2006
Jill Wechsler |
Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules. |
Bio-IT World
November 2006
Mark D. Uehling |
Putting EDC on the Fast Track There's no escaping the imposing numbers of choices in launching a clinical trial using electronic data capture. Is there a better way? Clinical trial consultant Fast Track Systems says it has one. |
Bio-IT World
August 13, 2002
Mark D. Uehling |
Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way? |
Bio-IT World
April 16, 2004 |
Best of the Best, Sir The FDA wants to change its ways and share its accumulated wisdom as part of a focused attack on costly, unpredictable product development. |
The Motley Fool
February 16, 2010
Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
The Motley Fool
December 22, 2003
Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
Bio-IT World
March 10, 2003
Spink & Blumenstiel |
Getting IT Right Applying information technology to trials can boost productivity. Here's a strategic framework for going e-clinical. |
Pharmaceutical Executive
September 1, 2013
Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
Bio-IT World
March 17, 2004 |
Speeding EDC Adoption Implementation by clinical sites is lumbering along at an unimpressive rate. Here's what must be done to speed things up |
Bio-IT World
May 9, 2003
Mark D. Uehling |
Data Rapture? Electronic capture of data: Some say it unclogs the medieval clinical trials process. Others remain skeptical of software and put their trust in paper. |
Chemistry World
June 8, 2015
Rebecca Trager |
NIH drug manufacturing unit shut down The halt could potentially affect 46 clinical trials, and about 250 patients who are either receiving, or about to receive, products manufactured at the facility. |
Bio-IT World
March 17, 2004
Kenneth Getz |
Getting Past No Low adoption rates of e-clinical trial technology can't be blamed on external market dynamics alone. Biopharmas must face four inhibitors within their own organizations |
Pharmaceutical Executive
January 1, 2006
Clinton & Wechsler |
What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay? |
Managed Care
July 2005
Martin Sipkoff |
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. |
Bio-IT World
December 15, 2003
Mark D. Uehling |
Model Patient Despite the FDA's new support for computational modeling, the pharmaceutical industry remains cautious about simulating clinical trials. |
Pharmaceutical Executive
April 1, 2012
Jill Wechsler |
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. |
AskMen.com
Richard Stevens |
Participating In Clinical Trials Check out what participating in clinical trials involves and how you can join a study. You may even make some cash in the process. |
Bio-IT World
June 2005
Mark D. Uehling |
Abandon Paper! Use a PDA! The entire pharmaceutical industry is migrating away from paper diaries, fraught as they are with patients' well-meaning but well-documented procrastinations and fabrications. But electronic gadgets are not inexpensive, even for rich sponsors of clinical trials. |
The Motley Fool
March 29, 2010
Brian Orelli |
Look for Companies That Strike First Head-to-head trials, whether they're run by companies or by third parties, can be scary. But the way to make big money is by selling drugs that offer superior benefits, so investors should welcome the onslaught of upcoming comparative trial data. |
AskMen.com
Joshua Levine |
Selling Your Body To Science Have you ever thought about the number of voluntary patients who basically sell their bodies to clinical trials in the name of science? Well, the number is staggering and it can reach well into the thousands. The main reason being the large paycheck that comes with the job. |
Chemistry World
November 12, 2013
Dinsa Sachan |
Rough patch for India's clinical trial industry The Indian clinical trial industry is beset by uncertainty. Campaigners have petitioned the courts claiming that drug companies are exploiting poor people and this has led to more than 100 trials being put on hold. |
The Motley Fool
December 31, 2011
Brian Orelli |
3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012. |
Information Today
July 2, 2013 |
Thomson Reuters Offers Clinical Trial Intelligence Solutions These solutions improve clinical trials, speed up product development and release, and help professionals strengthen portfolios and R&D strategy. |
Pharmaceutical Executive
September 1, 2008
Melanie North |
Publish or Perish FDAAA means that companies need to register clinical trials; and not only for publication planning. |
Bio-IT World
October 2005
Mark D. Uehling |
Phase Forward Acquires Lincoln Technologies As the most intriguing clinical trial technology deal of the year, the acquisition demonstrates both Phase Forward's financial resources and the appeal of Lincoln Technologies' Java- and Web-based tools for the analysis and visualization of drug safety. |
Chemistry World
October 15, 2013
Dinsa Sachan |
Supreme court ruling brings clinical trials to a halt in India The fate of 162 global clinical trials hangs in the balance, as the top Indian court has asked the government to provide more details on their approval process before they can proceed. |
Chemistry World
January 25, 2013
Rajesh Parishwad |
Indian supreme court's anger over unregulated clinical trials The fledgling clinical trials industry in India has been hit by recent revelations of a lack of regulation. Now, the country's supreme court has criticized the body that oversees clinical trials for its inaction in the face of these unethical practices. |
Pharmaceutical Executive
October 1, 2008
RS Kumar |
Evolving Clinical Trials Clinical trials need to change. A recent survey shows that industry should address the research supply chain for the greatest gains in efficiency. |
Pharmaceutical Executive
March 1, 2012
Ron Cohen |
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. |
IndustryWeek
October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |
Pharmaceutical Executive
June 1, 2011
Zhang & Dubman |
To Genzyme, Quality Data Depends on Quality Governance The payoff is superior performance in key areas such as clinical trials |
Pharmaceutical Executive
June 1, 2012
Jill Wechsler |
Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market. |
Pharmaceutical Executive
January 1, 2009
Jill Wechsler |
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? |
Bio-IT World
November 14, 2003
Amnon Shabo |
Integrated EHR: The Final Frontier Harmonizing various standards for electronic health records will have far-reaching effects on bioinformatics. |
Bio-IT World
March 8, 2005 |
Coming Attractions Ten reasons why you can't miss the Bio*IT World Conference + Expo in May. Headlines and Legends... Advances in Genomic Medicine... IT Solutions for Drug Discovery... etc. |
