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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. |
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 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 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 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 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 |
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 October 2006 William Claypool |
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. |
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 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 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 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. |
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 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 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. |
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 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 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 |
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 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 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, 2012 William Looney |
Today's Mission Critical: Making Sense of Spending on Clinical Trials Mastery of the clinical trial process has become essential to positioning new therapies for leadership in an increasingly crowded and lengthy race to registration. |
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 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 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. |
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. |
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 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. |
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 Dawn Stover |
E-Recruitment: Trial by Wire Online databases are helping patients find clinical trials -- but e-recruitment is no panacea for participant shortages. |
Bio-IT World Dec 2006/Jan 2007 Mark D. Uehling |
Vertex Views Trial Supplies For a recent clinical trail, the head of clinical development systems at Vertex Pharmaceuticals found a new software offering from Tourtellotte Solutions. |
Bio-IT World April 2006 Michelle Zubatch |
Value of Hosted Clinical Data Environments Instead of burning through venture capital, different levels of hosted clinical data management systems environments are available from clinical consulting vendors for efficiency-conscious clinical firms. |
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 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 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 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. |
The Motley Fool October 12, 2010 Travis Hoium |
Geron Shares Popped: What You Need to Know Geron shares jumped 10% after the company announced that its first patient has enrolled in the company's stem cell clinical trial. |
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 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 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 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? |
Pharmaceutical Executive November 1, 2011 Elizabeth O. Coulton |
Clinical Trial Issues Not Just Black and White The selection of clinical trial participants must meld with the changing demographics of America if industry is to improve medicines that work for patients. |
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. |
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. |
Bio-IT World August 18, 2004 John Russell |
A Dozen Sparkling Gems A snapshot of deserving Best Practices Awards entries: Locus Pharmaceuticals... Children's Memorial Hospital, Chicago... XOMA... University of Texas Health Science Center... etc. |
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. |
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. |