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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 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 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 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 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 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. |
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. |
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. |
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. |
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 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, 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 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. |
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 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 May 17, 2010 Luke Timmerman |
Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir. |
Information Today July 9, 2015 |
The BMJ Requires Patient-Level Data for Publication The BMJ is now applying its data-sharing policy to all clinical trials. |
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. |
The Motley Fool February 16, 2010 Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
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 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 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. |
The Motley Fool February 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon. |
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. |
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. |
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. |
The Motley Fool December 27, 2011 Brian Orelli |
2011 No Dreamboat for MannKind An FDA rejection and a long wait is a bad combination. |
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. |
Managed Care July 2005 Martin Sipkoff |
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. |
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. |
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. |
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. |
The Motley Fool July 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
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. |
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. |
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. |
The Motley Fool September 5, 2006 Brian Lawler |
Adolor: Positive Results, Negative Reaction The market seems confused by good results from Adolor's latest clinical trial. Investors willing to take a gamble on Adolor at this price may be in for huge rewards if the company and Glaxo can convince the FDA of Entereg's viability. |
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. |
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. |
The Motley Fool July 6, 2007 Brian Orelli |
Pain-Free Phase 2 Data Anesiva's pain medication is moving up the clinical trial ladder. The Adlea results are very promising, but investors should look at the state of the entire company before investing. |
The Motley Fool December 27, 2006 Brian Lawler |
Telik Falls Short Shares of another biopharma fall after disappointing clinical trial results. |
The Motley Fool August 3, 2009 Brian Orelli |
The Roller-Coaster Stock That Keeps on Giving Savient's gout treatment isn't approved just yet. |
The Motley Fool December 31, 2011 Brian Orelli |
3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012. |
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. |
The Motley Fool January 20, 2011 Brian Orelli |
This Stock Is No Dreamboat The FDA is not kind to MannKind. |
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. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
Bio-IT World February 2006 Mark D. Uehling |
Pharma's Mixed Response to Trials Database A late December New England Journal of Medicine article detailed Big Pharma's response to mandatory registration of clinical trials. Here are some highlights. |
The Motley Fool July 10, 2006 Brian Lawler |
Northfield Frowns on Focus From "20/20" The maker of artificial blood finds yet another critic. But the impending end of the PolyHeme trial probably won't represent the end of criticism of the artificial blood. Only if good clinical trial results are announced later this year will Northfield's critics be silenced. |
Information Today July 2, 2013 |
Thomson Reuters Offers Clinical Trial Intelligence Solutions These solutions improve clinical trials, speed up product development and release, and help professionals strengthen portfolios and R&D strategy. |