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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. |
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 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 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. |
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 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 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. |
Bio-IT World January 21, 2005 Sprouse & Shiple |
Strategic Insights: Building Integrated Research Networks Uniting a region's medical centers on clinical projects could create a new model for clinical trials. |
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 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. |
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. |
Pharmaceutical Executive July 1, 2005 Ellen H. Julian |
What Pharma Wants From IT Today Indications that compliance and productivity issues reign over information technology (IT) budgets at pharma companies were verified in the 2005 Pharmaceutical Executive/Life Science Insights Information Technology Survey of nearly 850 US pharma companies. |
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 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. |
Bio-IT World March 2006 Mark D. Uehling |
Oracle Discusses Agenda for Clinical Trials In surprising ways, Fusion is helping to shape Oracle's strategy in the clinical trial space. |
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 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 April 2007 Deborah Borfitz |
Fusion Makes the Difference at Oracle With Fusion, Oracle will begin combining the best features of its JD Edwards, Siebel, and E-Business Suite product lines to form a new collection of web-based applications based on service-oriented architecture. Many life science companies globally run Oracle applications. |
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 |
Bio-IT World Dec 2006/Jan 2007 Deborah Borfitz |
Rave Review for Medidata's Asian EDC Advantage Tokyo-based Astellas Pharma will use Medidata's Rave 5.5 for all its global clinical studies over the next five years. Another new biopharma customer for Rave is AstraZeneca. |
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 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 October 2006 William Claypool |
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. |
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 April 2007 Deborah Borfitz |
EDC Guru Moves from Novartis to Kendle The publicly owned clinical research organization Kendle recently brought the pragmatic Sylva Collins on board to provide leadership for its global biometrics offerings and help it become "the unparalleled leader in e-clinical services." |
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 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. |
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 May 2006 Mark D. Uehling |
Bio-IT World CTMS Survey An online survey of the clinical trial management system market reveals some divergences between how the pharma/biotech folks and the contract research folks see the CTMS landscape. Are our respondents happy with the CTMS landscape? |
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 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. |
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. |
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 2006 Mark D. Uehling |
Datasci Suits Threaten Industry The U.S. Patent Office is under scrutiny in a series of lawsuits that are baffling the world of clinical trial technology. |
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 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 March 17, 2004 |
Strategic Insights Clinical Trials Major drug developers have put electronic data capture to the test and found benefits ranging from instant data access to fewer truckloads of paper. Yet many clinical sites are slow to accept the technology. |
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 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. |
Bio-IT World May 2006 Chris Connor |
Will SOX Crush Clinical Development? Just as clinical operations and data management personnel were feeling as though they had tamed their compliance beasts of burden, many life science companies have noticed another elephant in the living room, and this one is wearing SOX. |
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. |
Bio-IT World September 11, 2003 Philip D. Quarles |
Safeguarding the Security of Clinical Data Given the frequency of Web site attacks, can data be safely stored on a server connected to the Internet? Yes, provided that the application is properly designed and the network and server properly secured. |
Bio-IT World November 2005 Charles Firneno |
The Information Value Chain By looking at the evolution of pharma's information networks, strategies can be designed for IT solutions such as CRM, CTMS, AERSs, and business analytics software to deliver the highest possible value. |
Bio-IT World Jul/Aug 2006 Mark D. Uehling |
RIP, Data Managers? Do people working in data management at drug discovery firms have a future? |