Clinical Operations Featured Articles

  1. Lupus Research Alliance Enhances Clinical Trials for Patients 6/16/2017

    The Lupus Research Alliance is the largest non-profit health organization raising money for research into the cause, cure, treatment, and prevention of Lupus and its complications. The research programs funded are typically collaborations with hospitals, medical schools and universities, as well as pharmaceutical companies from around the world. While treatments are available, Farber notes they are far from perfect. This has led the Lupus Research Alliance to step up its efforts to improve clinical trials and get ned medicines to patients.

  2. SCRS Drives Site Payment Solutions 6/7/2017

    Earlier this year, site payment issues were front and center at the European Site Solutions Summit that took place in Barcelona. The Summit, presented by the Society for Clinical Research Sites (SCRS), provides a forum for clinical stakeholders to discuss opportunities to improve clinical trials. In this Q&A, Dan Milam, VP of Global Engagement for SCRS, discusses the Summit, the issue of site payments, and what progress is being made.

  3. Site Payments Still A Global Problem 6/1/2017

    Collecting payments has long been an issue for clinical sites, especially those without the financial resources to withstand payment terms of 90 to 120 days. At the SCRS Global Site Solutions summit last fall, I even heard site personnel state they will pay less attention to studies where the sponsor or CRO does not make payments in a timely manner. We know that 40 percent of sites have cited slow payments as a primary operating concern. Financial stress at sites may even be negatively impacting the success of clinical trials.

  4. Can A New Outsourcing Approach Improve Clinical Trials? 4/25/2017

    For companies wanting to outsource their trials but also harbor concerns over CRO size and staffing, is there a solution? One group thinks they have come up with the answer. Four companies have come together to form a consortium designed to provide pharma with a dedicated team of trial experts focused on making studies more efficient and cost effective. Current members of the alliance include FMD K&L, inSeption Group, Pyxa Solutions, and OneSource Regulatory, with a plan to add more members in the future.

  5. Proposed Tax Change Would Impact Clinical Research 4/11/2017

    Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.

  6. AstraZeneca Strives For Greater Trial Transparency 3/22/2017

    In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.

  7. Open Source Data: Fact Or Fiction 3/3/2017

    At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.

  8. Clinical News Roundup: Women Significantly Benefit From OB/GYN Trials 3/3/2017

    Clinical news roundup for the week of February 26 with information on women and OB/GYN trials, Sanofi partnering with Science 37, benefit explanations tied to increased recruitment, digital tools, and patient recruitment in rare disease trials.

  9. Are You Conducting Proper CRO Oversight? 3/2/2017

    Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.

  10. GSK Uses Apple ResearchKit In Rheumatoid Study 2/21/2017

    As the chief medical officer at GSK, Murray Stewart spends most of his time focused on patients. A recent PARADE (Patient Rheumatoid Arthritis Data from the Real World) study, launched last year, was the first time GSK attempted to use Apple ResearchKit in a clinical study. Within 48 hours, the company had over 200 downloads, and was hopeful they would not just receive data from patients, but insightful information.