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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. |
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 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 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 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? |
Fast Company December 2009 Elizabeth Svoboda |
Biotechs Look Overseas to Launch a Stem-Cell Revolution According to one small biotech, the best way to launch a stem-cell revolution is to do it overseas. |
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 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 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 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 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 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. |
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 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 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 January 1, 2011 Singh & Glozman |
Managing Clinical Trials in Emerging Markets Amgen's hub-and-spoke system combines control at home with the flexibility to respond to local needs. |
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 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 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 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. |
Chemistry World February 26, 2014 Ned Stafford |
Roche disputes unethical East German trial claims Clinical trials in the 1980s, performed in former communist East Germany by global pharmaceutical giant Hoffmann-La Roche, adhered to international standards and did not violate East German laws, according to a report issued by the company after a six month internal investigation. |
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. |
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 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. |
Pharmaceutical Executive April 1, 2012 Feam & Lagus |
Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help. |
Pharmaceutical Executive October 1, 2006 Clinton & Koroneos |
Learn & Confirm At Wyeth, a sweeping set of initiatives is transforming the R&D operation - and spotlighting a possible future for drug development. |
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. |
Pharmaceutical Executive June 1, 2014 Jill Wechsler |
Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D. |
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 1, 2007 Dinh Nguyen |
Clinical Trials Under Scrutiny Over the last few years, there has been a growing number of instances of misconduct in clinical research. |
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 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 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 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. |
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 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 October 2006 William Claypool |
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. |
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 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. |
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. |
Pharmaceutical Executive February 1, 2007 John Smith |
Public Relations: Beef Up Clinical Trial Numbers Web-based public relations can make the difference in clinical-trial recruitment. |
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. |
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. |
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. |
The Motley Fool May 17, 2010 Luke Timmerman |
Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir. |
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 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 Jul/Aug 2006 Mark D. Uehling |
RIP, Data Managers? Do people working in data management at drug discovery firms have a future? |
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. |
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. |