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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. |
Pharmaceutical Executive April 1, 2009 David Zuckerman |
Make a Match Big Pharma is finally making a commitment to partner-based outsourcing. |
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 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 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 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 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 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. |
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 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 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 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. |
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 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 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 June 1, 2011 |
Filling in the Bigger Picture Part II of The Avoca Group's 2011 CRO survey on clinical development outsourcing relationships. |
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 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 February 1, 2011 Stergiopoulos et al. |
Honing Reforms from Clinical Development Increased efficiency and lower operating costs for both CROs and vendors can be achieved by eliminating activities |
Pharmaceutical Executive March 1, 2011 |
Clinical Development Outsourcing: Are We Having Fun Yet? A sneak preview of The Avoca Group's 2011 Annual Survey on CRO and Industry Relationships. |
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 September 16, 2004 Paul King |
Growing Gains When it comes to information technology requirements, the biotech industry is unlike any other. A key enabler of efficient and effective growth is the adoption of IT strategies specific to each of four key stages. |
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 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? |
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 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 July 15, 2003 |
The BRAIN Behind BCM's Clinical Trials What ultimately came to be called the Biomedical Research and Information Network, or BRAIN, took two years to build and cost Baylor College of Medicine $1.5 million. Yet no one doubts the value of the investment. |
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. |
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 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 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 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. |
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. |
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. |
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. |
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. |
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 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. |
The Motley Fool December 8, 2004 Alyce Lomax |
Eli Lilly Bares All The pharmaceutical publishes clinical trial results online. This is a step toward generating trust -- after all, shareholders, physicians, and consumers alike are likely looking askew at Big Pharma these days. |
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. |
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. |
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 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. |
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. |
The Motley Fool November 30, 2007 Brian Orelli |
Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way. |
Bio-IT World March 8, 2005 Mark D. Uehling |
Is That a Target on Her Back? Q&A with Deborah Zarin, head of ClinicalTrials.gov, the matchmaking Web site for patients seeking to participate in federally sponsored clinical trials. |
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. |
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 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 |
Pharmaceutical Executive December 1, 2011 Lujing Wang |
The Payoff for Payers Thorough risk assessment is essential before placing bets on good evidence that clears a path to approval. |