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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 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. |
Reason October 2007 Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
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. |
Salon.com August 18, 2000 Vera Hassner Sharav & Adil E. Shamoo |
Lab rats Why do people who participate in clinical studies have fewer protections than animals? |
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. |
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. |
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. |
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. |
Pharmaceutical Executive March 1, 2014 Jill Wechsler |
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. |
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. |
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 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. |
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 April 1, 2012 Jill Wechsler |
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. |
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, 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, 2013 Jill Wechsler |
Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise. |
Pharmaceutical Executive March 1, 2009 Jill Wechsler |
Through the Looking Glass Pharma relations with researchers are critical for developing new technology, and reformers will discourage inappropriate relationships by making any links to pharmaceutical marketing known to all. |
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 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. |
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. |
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. |
Pharmaceutical Executive February 1, 2013 William Looney |
Pathways to Progress Cancer is increasingly understood as a collection of rare and mostly treatable conditions rather than the impregnable, monolith portrayed in popular culture. Industry experts review current and pending efforts to turn great science into good practice. |
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. |
Pharmaceutical Executive October 1, 2005 Andy Bender |
Orchestrating Compliance Product managers at pharmaceuticals are not always happy to see their compliance officers. That may be changing. |
Chemistry World September 30, 2014 |
Transparency measures forced on pharma Previous misdemeanors are compelling the pharmaceutical industry to be more open with financial information and clinical data. |
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. |
Salon.com August 18, 2000 Arthur Allen |
Tainted alliances Are doctors shilling for drug companies? |
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. |
Pharmaceutical Executive October 1, 2010 |
Getting Ready for Sunshine Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research. |
Pharmaceutical Executive September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
Pharmaceutical Executive November 1, 2008 Jill Wechsler |
Resolving Conflicting Interests The Physician Payment Sunshine Act would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors. |
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 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. |
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. |
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. |
Managed Care April 2007 |
A Conversation With Emad Rizk, MD: Disease Management Beyond the Call Center The man who heads McKesson Health Solutions, the third largest disease management program in the country, says it's time to roll out a new model. |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. |
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 June 1, 2005 Joanna Breitstein |
Turn the Page Changes in ethics and expectations are driving the way pharma interacts with medical publishers. |
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, 2010 |
When the Payer IS the Player As Medicare, Medicaid, and the nation's web of private payers gain market power, how can pharma stay ahead of the cost-containment curve? |
Pharmaceutical Executive July 1, 2014 Jill Wechsler |
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. |
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 January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. |
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. |
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. |
Managed Care September 2005 Arthur Lazarus |
Individual Wariness Needed To Spot Biased Drug Research Full and accurate disclosure of conflicts by researchers does not ensure the prevention of publication of articles that are misleading or otherwise biased. Impossible-to-enforce mandates won't work. Pharmacy directors and others must pose the right questions to the right people. |
Pharmaceutical Executive July 1, 2006 Derek Lowe |
What You Need to Know About Adaptive Trials A handful of new statistical techniques and clinical-trial designs will let you change the way you run your business. Here's your guide to the basics. |