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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.
Bio-IT World June 2006 Mark D. Uehling	Real-Time Trials Currently, there is more visibility into the precise location of a FedEx package than the progress of a multimillion-dollar clinical drug trial. But adaptive design trials are changing that.
Bio-IT World March 10, 2003 Kenneth Getz	E-Clinical Technology Overview Clinical trial researchers want to leverage the benefits of IT -- and now they can for every core process. But they also have to get past the barriers to adoption.
Pharmaceutical Executive November 1, 2006	Unraveling the eSource Industry-wide standards for electronic patient data have long felt like buried treasure. Companies today are getting closer - by way of a tangled map.
Bio-IT World August 18, 2004 Mark D. Uehling	Master of the EDC Universe An interview with Sylva Collins, global head of advanced clinical systems at Novartis, who in the case of electronic data capture (EDC), proved to the pharmaceutical industry that technology could be transformative in clinical trials.
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 July 1, 2006 Jeannette Park	Roundtable: Are We There Yet? How About Now? Now? Can Electronic Data Capture become the industry standard for clinical trials? In this roundtable discussion, six early adopters reveal where they struggled, and what you need to know to implement this new technology.
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.
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.
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 Dec 2005/Jan 2006 Mark D. Uehling	Convergence of EHR and EDC The hypothesized convergence of applications and databases for drug development, clinical trials, hospitals, and physicians is both closer and more distant.
Bio-IT World July 2005 David Fishbach	Does EDC Herald the End of CTMS? Clinical trial managements systems (CTMSs) and Electronic data capture systems (EDCs) are compared with respect to their history, advantages and disadvantages. Studies suggest both have enough advantages to survive in some form of integrated solution.
Bio-IT World May 2006 Mark D. Uehling	Clinical Speakers Enjoy Industry Acceptance For the first time at the Bio-IT World Conference, the clinical speakers did not wring their hands about whether their tools would be accepted by the industry. This year, it was a question of how quickly technology would be used to expedite trials and raise the quality of the data therein.
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 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 June 2006 Mark D. Uehling	Afferenz on EDC, Images, and Data Integration There are people who think the outsourcing of IT to India will not affect the life sciences. But companies like Afferenz raises concerns about U.S. companies lagging behind Indian companies on laying the foundation for clinical trials.
Bio-IT World January 13, 2003 Mark D. Uehling	Powerhouse CRO (Slowly) Goes Electronic Unhappy customers at Quintiles -- the world's largest CRO (contract research organization) -- are rare. It kept plugging away at the startup process, redesigning it from scratch. Now starting electronic trials takes no longer than paper ones.
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
Bio-IT World Dec 2006/Jan 2007 Mark D. Uehling	CDISC Sees Growth in Standards Sponsors of clinical trials, large and small, are starting to see the wisdom in standards. That growing support was plain to see at the Clinical Data Interchange Standards Consortium's annual meeting.
Bio-IT World April 16, 2004 Joel Hoffman	Taking the Trial Out of Clinical Outsourcing Make sure the vendor's standard operating procedures will mesh with your own, and then tirelessly work toward systems integration.
Pharmaceutical Executive June 9, 2014 Getz et al.	Adaptive Trial Design: Prepping for Adoption Biopharmaceutical companies are targeting improvements in clinical trial design as a critical factor in pipeline portfolio success.
Bio-IT World Dec 2006/Jan 2007 John Mestler	e-Harmony: EDC and e-Health Records Bringing bio-pharmaceutical requirements to the table with government eHealth designers in the US, EU, and around the world is the beginning of the necessary fusion of electronic health records and electronic data capture.
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.
Pharmaceutical Executive July 1, 2005 Rob Case	In Search of the Holy Grail Chasing ultimate clinical trial efficiency, one small step at a time. A carefully considered approach to data integration can benefit every stakeholder from the investigator to the pharmaceutical executive.
Bio-IT World February 2006 Chris Connor	Has EDC Jumped the Shark? As data management teams begin to deploy electronic data capture in their clinical trials, "cool" gives way to the cool reality that IT investments have to produce real results.
Bio-IT World February 2007 Beth Harper	Meshing EDC with CTMS Many unsolved problems in conducting clinical trials cause delays, wasted resources, team frustration, and even safety issues. Thus, the industry is turning more of its attention away from Electronic Data Capture to Clinical Trial Management Systems.
Bio-IT World April 16, 2004 Mark Uehling	PDAs and Clinical Trials PalmOne's director of healthcare sales explains why clinical trials are driving sales of handheld devices.
The Motley Fool May 31, 2011 Brian Orelli	5 Biotechs With Upcoming Clinical Trial Results Investors willing to stay in these stocks a little while could see substantial gains well ahead of FDA approvals.
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 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 January 21, 2005	How IT Can Decrease Time-to-Market in Clinical Trials Pharma manufacturers can learn from their industrial counterparts: Integrating systems can accelerate product delivery.
Bio-IT World March 10, 2003 Dawn Stover	E-Recruitment: Trial by Wire Online databases are helping patients find clinical trials -- but e-recruitment is no panacea for participant shortages.
Chemistry World August 7, 2013 Emma Stoye	AllTrials releases plan for clinical trial reporting The organizations behind AllTrials, a public campaign calling for detailed information on clinical trials to be publically available, have put together a detailed plan on how to achieve clinical trial reporting on a global scale.
Bio-IT World November 19, 2004 Mark D. Uehling	Safety Last? Antiquated reporting of adverse events in clinical trials is costing pharma billions and forcing it to seek new pharmacovigilance solutions.
Pharmaceutical Executive March 1, 2013 Ken Getz	Building Clinical Trial Awareness for Patients: Why Not Try the Pharmacist? The author explains how building a stakeholder outreach agenda around the community pharmacist can lead to a better outcome in managing the complex ins and outs of a trial protocol.
Bio-IT World March 17, 2004 Paul Bleicher	Winning at EDC Implementation Adoption may be lagging at the enterprise level, but there's a stalwart group of biopharmas making EDC happen. Here's how they're doing it
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 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 October 2006 William Claypool	The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise.
The Motley Fool June 17, 2010 Luke Timmerman	Oncothyreon's Cancer Vaccine Back in the Saddle as Merck KGaA Re-Starts Clinical Trials The German-based Merck got clearance from the FDA and local ethics review boards to resume two of three large pivotal trials.
Bio-IT World May 2006 Nick Richards	The Unifying Power of Ajax Asynchronous JavaScript and XML (Ajax) will simplify the collecting of clinical trials data. As the pharmaceutical industry and contract research organizations moves toward electronic data capture, Ajax technology can smooth the way.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
Bio-IT World August 18, 2004 Anthony Strattner	Opportunity to Gain or Lose A keynote speaker at Best Practices ceremony asserts that drug-development science -- those activities that go beyond translational science and into product testing and commercialization -- has stagnated, causing a pipeline problem.
Pharmaceutical Executive October 1, 2005 Lisa Grimes	Clear Road Ahead An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction.
Bio-IT World May 19, 2004 Mark Uehling	Patients Without Borders As biotech companies search for patients abroad, technology clearly matters--but not every clinical trial on the planet is ready for electronic data capture.
Bio-IT World April 15, 2003 Paul Bleicher	E-Sourcing: Covering the Regulatory Bases Capturing clinical source data electronically can hit a home run for trial efficiency and safety -- but access control is key. Here's an expert guide.
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.
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.
Pharmaceutical Executive November 1, 2012 Sue Barrowcliffe	Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options.