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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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Bio-IT World
October 2006
William Claypool
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2013
Jill Wechsler
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
IEEE Spectrum
October 2011
Joseph M. Smith
Wireless Health Care Wireless technologies are about to transform health care, and not a moment too soon mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles