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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 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 July 15, 2003 Mark D. Uehling |
Patient, Record Thyself As e-diaries get a boost -- and a knock -- from the FDA, Invivodata focuses on helping patients log their experiences. |
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. |
Bio-IT World May 2006 Mark D. Uehling |
PHT, invivodata, CRF Settle Lawsuit PHT, the Boston-based electronic patient diary company, has settled two patent lawsuits. The first salvo in the legal battle was fired in January 2004, and the case was just about to go to trial when the settlement was announced early in April. |
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 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 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 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. |
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 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, 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 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 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 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 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 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 October 2006 William Claypool |
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. |
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 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 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 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. |
The Motley Fool September 7, 2010 Luke Timmerman |
Vertex Nails Third Big Trial With Hepatitis C Drug And in the toughest patients to treat, too. |
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 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 |
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. |
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. |
Pharmaceutical Executive September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
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. |
Bio-IT World December 15, 2003 Mark D. Uehling |
Model Patient Despite the FDA's new support for computational modeling, the pharmaceutical industry remains cautious about simulating clinical trials. |
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. |
The Motley Fool January 3, 2011 Brian Orelli |
Clinical Trial Results Fail to Inspire Inspire Pharma gets cut in half after a cystic fibrosis trial failure. |
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. |
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. |
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 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. |
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. |
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. |
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 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 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. |
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 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 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. |
IEEE Spectrum October 2011 Joseph M. Smith |
Wireless Health Care Wireless technologies are about to transform health care, and not a moment too soon |
The Motley Fool September 14, 2010 Luke Timmerman |
Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug. |
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. |