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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 August 1, 2008 Brian Orelli |
Recession Schmession, This Industry Is On Fire Contract research organizations do pre-clinical research and run clinical trials for drug developers on the cheap. With pharmaceutical companies cutting back on costs, CROs are in the perfect position to benefit. |
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. |
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. |
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 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. |
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 July 27, 2007 Tom Taulli |
A New Phase for Phase Forward Phase Forward wins a multi-million dollar contract for its clinical trial software; this infusion of cash provides even more resources for pursuing more growth. |
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 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 December 1, 2013 Vansgaard et al. |
Develop Drugs for People, Not Just Bodies A patient-centric approach to drug development delivers the benefits that actually create value |
The Motley Fool September 8, 2010 Brian Orelli |
You Must Realize This Drug Works by Now Vertex concludes its phase 3 trials with another win. |
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 2007 Malorye Allison |
Biomarkers versus Blockbusters Are companies really changing their strategies and using biomarkers to target smaller, better defined patient sets with their new drugs? Or is the vast majority of pharma biomarker studies just aimed at culling bad drugs from their pipelines? |
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? |
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. |
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. |
The Motley Fool December 29, 2011 Brian Orelli |
What to Look for From Keryx and Aeterna Zentaris in 2012 The future is uncertain for these pharmaceutical companies. |
The Motley Fool April 24, 2009 Robert Steyer |
Nothing to CRO About The good times have stopped rolling for Contract research organizations, as they warn of unexpected contract cancellations and reduced demand for services. |
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. |
The Motley Fool March 1, 2007 Brian Lawler |
Know Your Drug Stock ABCs: Part 2 Investing in the pharmaceutical and biotechnology industries can be difficult. Here are terms investors should know to better understand how the clinical trial process involved with bringing a drug to market works. |
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 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 December 29, 2006 Brian Lawler |
Is Threshold on the Verge of Success? Shares of Threshold Pharmaceuticals were the second-best performer on the market yesterday, up 28% as a result of positive phase 2 clinical trial results for its lead drug, glufosfamide. |
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 February 26, 2014 Ned Stafford |
Roche disputes unethical East German trial claims Clinical trials in the 1980s, performed in former communist East Germany by global pharmaceutical giant Hoffmann-La Roche, adhered to international standards and did not violate East German laws, according to a report issued by the company after a six month internal investigation. |
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 June 23, 2009 Brian Orelli |
Wonder Drug! Maybe? Get the facts before jumping on this one. |
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. |
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. |
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. |
The Motley Fool January 21, 2010 Brian Orelli |
Here's That Critical Merck Info You Missed Announcing clinical trial failures in a FAQ? Really? |
Chemistry World September 2007 Derek Lowe |
Column: In the Pipeline Will Phase Zero trials actually help drug development? |
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. |
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. |
Chemistry World June 8, 2015 Rebecca Trager |
NIH drug manufacturing unit shut down The halt could potentially affect 46 clinical trials, and about 250 patients who are either receiving, or about to receive, products manufactured at the facility. |
The Motley Fool June 29, 2007 Brian Orelli |
The Phase 2 Blues Drug developer Cytokinetics disappoints investors with failed clinical trials. |
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. |
Wired March 2006 Jennifer Kahn |
A Nation of Guinea Pigs There's a new outsourcing boom in South Asia - and a billion people are jockeying for the jobs. How India became the global hot spot for drug trials. |
Pharmaceutical Executive May 1, 2006 Madison, Chan & Seeger |
Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem. |
The Motley Fool March 30, 2009 Brian Orelli |
Change the Game? Change the Rules! There are ways for investors to get around Obama's plan to lower health care costs. Investing in drug companies in this time of "change" doesn't have to be scary. You've just got to find rule breaker-type drugmakers, because playing by the rules isn't going to cut it anymore. |
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. |
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 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 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 March 6, 2009 Brian Orelli |
For Drug Companies, R&D Is Spelled C-R-O It seems likely that more and more pharma companies will try to get more bang for their bucks by spending them on research and development done outside the company, outsourcing it to clinical research organizations. |
The Motley Fool November 14, 2011 Brian Orelli |
Biotech Uncertainty = Big Upside Potential Aastrom's phase 2 and phase 3 trials don't match up. |
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. |
The Motley Fool August 11, 2010 Brian Orelli |
Dang! This Drug Is Shining Brighter Vertex illuminates telaprevir's additional benefit in treating hepatitis C patients. |